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		<title>FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options</title>
		<link>https://www.creative-biolabs.com/blog/index.php/fda-taking-new-steps-to-better-inform-physicians-about-biosimilars-through-education-about-these-potentially-cost-saving-options/</link>
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		<dc:creator><![CDATA[biolabs]]></dc:creator>
		<pubDate>Tue, 21 Nov 2017 07:52:10 +0000</pubDate>
				<category><![CDATA[Antibody Engineering Research]]></category>
		<category><![CDATA[biosimiar]]></category>
		<category><![CDATA[Therapeutic Antibody]]></category>
		<guid isPermaLink="false">http://www.creative-biolabs.com/blog/?p=1127</guid>

					<description><![CDATA[&#8220;The global biosimilar market is growing rapidly as patents on blockbuster biologic drugs expire.Although many companies are keen on getting a share in the biosimilars market given its promising outlook, bringing these<a class="moretag" href="https://www.creative-biolabs.com/blog/index.php/fda-taking-new-steps-to-better-inform-physicians-about-biosimilars-through-education-about-these-potentially-cost-saving-options/">Read More...</a>]]></description>
										<content:encoded><![CDATA[<p><em>&#8220;The global biosimilar market is growing rapidly as patents on blockbuster biologic drugs expire.Although many companies are keen on getting a share in the biosimilars market given its promising outlook, bringing these complex molecules from bench to launch can be a challenge, not just during the development stage but also in terms of the manufacturing process involved.Key guidance documents and education from FDA aim to help manufacturers utilize recommended methods for developing and testing biosimilars, including a recent draft guidance that outlines statistical approaches for evaluating analytical similarity. &#8220;</em></p>
<p>The cost of prescription drugs is an ongoing concern, however, a growing market for potentially lower-cost biological products called biosimilars can offer more competition and options for patients.</p>
<p>Biosimilars can potentially reduce costs for consumers by creating price competition for products that previously faced few market competitors. FDA wants to ensure that health care providers have the information they need when considering prescribing biosimilars when these products are available.</p>
<p>An FDA-approved biosimilar is highly similar to — and has no clinically meaningful differences in terms of safety, purity and potency (safety and effectiveness) from — an already FDA-approved biological product, called the “reference product.” In general, biological products are highly complex and are often used to treat patients with serious and life-threatening conditions.</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/11/FDA-training.png"><img decoding="async" fetchpriority="high" class="aligncenter size-full wp-image-1128" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/11/FDA-training.png" alt="FDA training" width="581" height="392" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/11/FDA-training.png 581w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/11/FDA-training-300x202.png 300w" sizes="(max-width: 581px) 100vw, 581px" /></a></p>
<p>FDA is working to help ensure that patients and their health care providers are well informed about biosimilars.</p>
<p>FDA’s Center for Drug Evaluation and Research (CDER) has approved seven biosimilars to date.  As more biosimilars are approved by FDA, we want health care providers to understand what these drugs are, and how they can help patients. So we are taking new steps to make sure providers are properly informed about biosimilars by launching an educational campaign today.</p>
<p>We planned and researched extensively prior to developing the materials for this education and outreach effort. Through this process, we learned the specific areas that health care providers had questions about. These include questions about the data and information FDA reviews when it’s making decisions to approve a biosimilar. Based on that feedback, FDA has developed educational materials to help health care providers gain a better understanding of these important products and the approval process they undergo. This includes fact sheets and graphics for health care professionals, as well as materials for organizations to use in disseminating this information to their interested members. These resources:</p>
<ul>
<li>Provide the basic definitions of terms like: biological product, reference product, biosimilar, interchangeable; and other terms to facilitate understanding of the relationship between biosimilars and their reference products;</li>
<li>Describe the rigorous standards any biosimilar must meet prior to approval and explain how the FDA approval pathway works for these products; and,</li>
<li>Provide easily accessible information about the data and information FDA reviews to determine biosimilarity, and how to find more resources.</li>
</ul>
<p>The new website also highlights information about an important reference for biosimilars known as the Purple Book. This reference can help prescribers and patients learn which biological reference products currently have one or more approved biosimilar or interchangeable product approved by FDA.</p>
<p>Next, FDA plans to embark on additional research with health care professionals to learn more about the types of information prescribers need to properly communicate with their patients about biosimilars. An increase in market competition, offered by a growing complement of biosimilars, may lead to meaningfully reduced costs for both patients and our healthcare system. As with the significant savings that we’ve seen through the introduction of generic drugs in the United States, biosimilars could also lead to substantial savings, thereby potentially improving access and promoting better public health outcomes. Understanding the rigorous process FDA uses to evaluate biosimilars can help prescribers and patients maximize the benefits from these products.</p>
<p>Source: https://blogs.fda.gov/fdavoice/index.php/2017/10/fda-taking-new-steps-to-better-inform-physicians-about-biosimilars-through-education-about-these-potentially-cost-saving-options/</p>
<p>&nbsp;</p>
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		<title>Top 10 R&#038;D Expense of Pharmaceutical Giants (II)</title>
		<link>https://www.creative-biolabs.com/blog/index.php/top-10-rd-expense-of-pharmaceutical-giants-ii/</link>
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		<dc:creator><![CDATA[biolabs]]></dc:creator>
		<pubDate>Wed, 01 Nov 2017 04:27:05 +0000</pubDate>
				<category><![CDATA[Antibody Engineering Research]]></category>
		<category><![CDATA[antibody development]]></category>
		<category><![CDATA[Antibody Discovery]]></category>
		<category><![CDATA[biosimiar]]></category>
		<category><![CDATA[Therapeutic Antibody]]></category>
		<guid isPermaLink="false">http://www.creative-biolabs.com/blog/?p=1094</guid>

					<description><![CDATA[6. AstraZeneca &#160; AstraZeneca&#8217;s research and development line was mixed last year. The Clinical Phase III trial result of Olaparib used for the treatment of BRCA mutations related advanced ovarian cancer after<a class="moretag" href="https://www.creative-biolabs.com/blog/index.php/top-10-rd-expense-of-pharmaceutical-giants-ii/">Read More...</a>]]></description>
										<content:encoded><![CDATA[<p><strong>6. AstraZeneca</strong></p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/AstraZeneca.png"><img decoding="async" class="aligncenter size-full wp-image-1095" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/AstraZeneca.png" alt="AstraZeneca" width="602" height="45" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/AstraZeneca.png 602w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/AstraZeneca-300x22.png 300w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/AstraZeneca-600x45.png 600w" sizes="(max-width: 602px) 100vw, 602px" /></a></p>
<p>&nbsp;</p>
<p>AstraZeneca&#8217;s research and development line was mixed last year. The Clinical Phase III trial result of Olaparib used for the treatment of BRCA mutations related advanced ovarian cancer after chemotherapy treatment was satisfactory. If everything goes smoothly, this drug will take up a large field.</p>
<p>Osimertinib Mesylate, an innovative drug that targets EGFRT790M-positive lung cancer, was eventually approved by the FDA at the end of 2016 after more than two years of clinical studies. Clinical data showed that this drug significantly had better effects than its competitor Clovis.</p>
<p>Qtern is a combined product (a fixed dose combination of saxagliptin and daglitaxel) that was listed on March 9 of 2017 after experiencing many setbacks. It may be able to restore AstraZeneca&#8217;s declining diabetes sector.</p>
<p>In the field of tumor research, anti-CTLA-4 monoclonal antibody <span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Anti-Human-CTLA4-Therapeutic-Antibody-Ticilimumab-=-tremelimumab-13493.htm" target="_blank">Tremelimumab</a> </strong></span>and PD-L1 inhibitor <span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Durvalumab-67669.htm" target="_blank">Durvalumab</a></strong></span> are highly anticipated. While, following Avelumab of Pfizer/Merck’s entering the market as the fourth one, AstraZeneca can only be the fifth to enter the market of immune checkpoint cancer drugs at most, ranking after Merck, Bristol-Myers Squibb, Roche, Pfizer and Merck.</p>
<p>Recently, increasing voices are questioning the toxicity of anti-CTLA-4 monoclonal antibody Tremelimumab in drug combination. As the problem gradually exposes its true appearance, AstraZeneca may take measures to deal with this crisis.</p>
<p>Last December, AstraZeneca spent $ 4 billion in the acquisition of AcertaPharma. This acquisition helped AstraZeneca gain Acalabrutinib. Acalabrutinib has an identified orphan drug status from CLL/SLL, MCL and lymphoplasmic lymphoma, and is of great market value.</p>
<p>Although Selumetinib has previously been identified as an orphan drug, repeated Clinical Phase III trial failure not only reduced people’s expectation on it, but may also lead to the termination of this project.</p>
<p>Taking into account the serious central side effects of the psoriasis drug IL17 antibody Brodalumab, the project partner Amgen withdrew from cooperation with AstraZeneca in 2015. However, it was eventually listed in February this year as other systemic treatment program without responding to adult moderate to severe plaques psoriasis.</p>
<p>ZS-9 is AstraZeneca&#8217;s nightmare. Hyperkalemia drug was purchased by AstraZeneca with $ 2.7 billion in 2015. During the acquisition, FDA refused its application because of its manufacturing factory. In March this year, FDA again refused its listing application with the same reason.</p>
<p>Faced with such operational pressure, AstraZeneca announced to cut $ 1 billion from its R&amp;D expense. Small department like neuroscience was directly dissolved.</p>
<p><strong>7. Sanofi</strong></p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Sanofi.png"><img decoding="async" class="aligncenter size-full wp-image-1096" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Sanofi.png" alt="Sanofi" width="598" height="44" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Sanofi.png 598w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Sanofi-300x22.png 300w" sizes="(max-width: 598px) 100vw, 598px" /></a></p>
<p>Sanofi&#8217;s local R&amp;D department in recent years had nearly no contribution, and almost all of the R&amp;D tasks were passed on to Regeneron and other partners. It is no wonder that CEO Elias Zerhouni emphasized the importance of coopertaion repeasdly. The first targeted biotherapy Dupixent (Dupilumab) for the treatment of moderate to severe atopic dermatitis (AD) was co-developed by Sanofi and Regeneron. It has been favored by the outside world, and is expected to change the market structure of this field. It is still in clinical trials of indications for nasal polyposis.</p>
<p>Another type of co-development rheumatoid arthritis drug sarilumab was rejected by FDA beacause of production line problem. It should have been surpassed by its rival Baricitinib (Eli Lilly, Incyte), but Baricitinib didn’t make it to the end. Currently, <span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Sarilumab-67711.htm" target="_blank">sarilumab</a></strong></span> is completing relevant data. Eli Lilly and Incyte are believed to have been far lagged behind.</p>
<p>Diabetes drug sotagliflozin is an SGLT-1/2 inhibitor, which is a product developed by Sanofi with a huge sum of money with Lexicon. While, no news are disclosed recently.</p>
<p>Anti-CD38 <span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Cetuximab-32082.htm" target="_blank">Isatuximab</a></strong></span> is a therapeutic agent for multiple myeloma and will compete with Johnson &amp; Johnson&#8217;s first CD38 targeted drug Darzalex for the market. However, Johnson &amp; Johnson has embarked on clinical work to expand the indications with the intention of reducing the loss caused by the competition.</p>
<p><strong>8. Eli Lilly</strong></p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Eli-Lilly1.png"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-1101" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Eli-Lilly1.png" alt="Eli Lilly" width="594" height="48" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Eli-Lilly1.png 594w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Eli-Lilly1-300x24.png 300w" sizes="(max-width: 594px) 100vw, 594px" /></a></p>
<p>Psoriasis drug Taltz&#8217;s successful approval last year was a good thing for Eli Lilly. The share of the market for biosimilar erosion over the years seemed to have improved by raising the price of medicine rather than introducing more new products.</p>
<p><a href="http://www.creativebiolabs.net/Anti-Human-Abeta-Therapeutic-Antibody-Solanezumab-13647.htm" target="_blank"><strong><span style="color: #0000ff;">Solanezumab</span></strong></a>&#8216;s third clinical trial failed. This drug seems to have no help in improving the condition of Alzheimer&#8217;s patients. JAK1/2 inhibitor Baricitinib was regarded as a groundbreaking drug of 2017, but was rejected because of security problem.</p>
<p>At the beginning of the year, Eli Lilly’s CEO stood down and handed over the power to the new CEO David Ricks, who began to cut spending and layoffs at the beginning of his term of office. Of course, this reduction in spending behavior in the industry is a common phenomenon, but Eli Lilly is always reluctant to completely reorganize their R&amp;D line. Compared to its peers, Eli Lilly does spend a lot in R&amp;D, and this situation will have to continue or it can‘t repair this tattered R&amp;D line.</p>
<p><strong>9. Gilead</strong></p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Gilead.png"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-1098" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Gilead.png" alt="Gilead" width="599" height="43" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Gilead.png 599w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Gilead-300x22.png 300w" sizes="(max-width: 599px) 100vw, 599px" /></a></p>
<p>In 2016, Gilead was eager to squeeze into the R&amp;D giant. It spent a total of $ 5.1 billion on research and development, but the investors were not satisfied with result brought by the huge amount of money.</p>
<p>The high efficiency showed in the clinical research data of the publication of the HIV drug Bictegravir may bring Gilead back to the glory of Hepatitis c cocktail era. Last year, the anti-alcoholic steatohepatitis drug acquired by Gilead with $ 600 million performed well in the recent data of Clinical Phase I trial.</p>
<p>In addition, Gilead&#8217;s position in the field of hepatitis C drugs is being threatened by factors such as drug price restrictions, imitation competition, and declining market capacity. Therefore, Gilead has had to shift the focus further to HIV.</p>
<p>In November 2016, Gilead spent $ 510 million to buy Momelotinib. It had a poor performance in the Clinical Phase III study of the treatment of myelofibrosis. The original research NASH drug GS-4997 has also been questioned. In addition, Gilead still had to terminate the clinical study of the repeatedly failed pancreatic cancer monoclonal drug simtuzumab and ulcerative colitis drug GS-5745.</p>
<p>Moreover, Gilead lost the lawsuit in the dispute with Merk. The court said that Sovaldi and Harvoni infringed upon the patent right of Merk, and asked Gilead to pay $ 2.54 billion of infringement fee.</p>
<p><strong>10. Bristol-Myers Squibb</strong><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Bristol-Myers-Squibb.png"><br />
</a></p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Bristol-Myers-Squibb1.png"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-1100" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Bristol-Myers-Squibb1.png" alt="Bristol-Myers Squibb" width="597" height="49" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Bristol-Myers-Squibb1.png 597w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/10/Bristol-Myers-Squibb1-300x25.png 300w" sizes="(max-width: 597px) 100vw, 597px" /></a></p>
<p>Bristol-Myers Squibb used to be a leader in the field of immune checkpoint inhibitors. Due to clinical frustration, it had to give the priority in this field to Merck’s Keyrruda.</p>
<p>Although Bristol-Myers Squibb did not do its best in market operation, but based on the company&#8217;s experience in the field of cancer immunization research, it continues to use the advantages and focus on this area in the future, emphasizing on researching the applications of LAG-3, GITR, CFS1R, IDO and other targets in the field of tumor. In addition to the field of cancer, CD28, TYK2 and BTK are also optimistic for the company&#8217;s research direction.</p>
<p>It seems that what Bristol-Myers Squibb need is time. This company has excellent research and development strength and is respected by the industry. While, accumulation is mostly needed for it, and of course, it also needs good business operation.</p>
<p>Previous: <span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creative-biolabs.com/blog/index.php/top-10-rd-expense-of-pharmaceutical-giants/">Top 10 R&amp;D Expense of Pharmaceutical Giants (I)</a></strong></span></p>
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		<title>Top 10 R&#038;D Expense of Pharmaceutical Giants (i)</title>
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		<dc:creator><![CDATA[biolabs]]></dc:creator>
		<pubDate>Fri, 29 Sep 2017 04:29:34 +0000</pubDate>
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		<guid isPermaLink="false">http://www.creative-biolabs.com/blog/?p=1072</guid>

					<description><![CDATA[Generally, when the business of a pharmaceutical giant reaches a plateau, its business volume won’t change much during this period. Instead, it will try to optimize its structure, including R&#38;D and production<a class="moretag" href="https://www.creative-biolabs.com/blog/index.php/top-10-rd-expense-of-pharmaceutical-giants/">Read More...</a>]]></description>
										<content:encoded><![CDATA[<p>Generally, when the business of a pharmaceutical giant reaches a plateau, its business volume won’t change much during this period. Instead, it will try to optimize its structure, including R&amp;D and production lines.</p>
<p>Similarly, it is not often to see erratic fluctuations in the R&amp;D expense of pharmaceutical giants. Most of the time, it sustains a steady increase. However, the R&amp;D expense of Merck in 2016 surged 3.4 billion US dollars. This year, we found through statistics that the total R&amp;D expanse of TOP 5 pharmaceutical enterprises has reached about 5 billion US dollars, among which Roche and Merck ranked first and second respectively. Gilead also increased its investment in R&amp;D, and spent 2 billion US dollars more than last year. While, it was not an easy year for Eli Lilly in terms of R&amp;D, as it experienced the failure of<span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Anti-Human-Abeta-Therapeutic-Antibody-Solanezumab-13647.htm" target="_blank"> Solanezumab</a></strong></span> and Baricitinib one after another.</p>
<p>The main reason for their increase in R&amp;D expanse is that they all saw the value of the tumor therapy area, tumor immune therapy in particular. Senior players have begun to divide ‘territory’, such as Bristol-Myers Squibb&#8217;s opdivo focused on PD-1 inhibitor field and Merck&#8217;s keytruda. Other players will soon be forced to leave the table. In a word, they have to speed up the progress before considering the return.</p>
<p>In addition to develop new products relying on their own R&amp;D team, acquisition is also a shortcut. One of the two biggest acquisition events of last year was Pfizer’s acquisition of Medivation for 14 billion US dollars. The outside world explained that Pfizer wanted to strengthen its own product line by this acquisition. It can obtain enzalutamide for prostate cancer and talazoparib for breast cancer through this acquisition. The other event was Johnson &amp; Johnson&#8217;s acquisition of Swiss biotech company Actelion for 30 billion US dollars. Analysts said that Johnson &amp; Johnson wanted to buy some potential products before the arrival of patent expiration. However, the outside world’s evaluations to these two acquisitions were different. The final result needs further observation.</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/rd-expense.jpg"><img decoding="async" loading="lazy" class="aligncenter wp-image-1073 size-full" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/rd-expense.jpg" alt="Income and R&amp;D expense proportion of pharmaceutical giants in 2016" width="608" height="431" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/rd-expense.jpg 608w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/rd-expense-300x213.jpg 300w" sizes="(max-width: 608px) 100vw, 608px" /></a></p>
<p>&nbsp;</p>
<p>1. Roche</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/roche.png"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-1074" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/roche.png" alt="roche" width="604" height="48" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/roche.png 604w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/roche-300x24.png 300w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/roche-600x48.png 600w" sizes="(max-width: 604px) 100vw, 604px" /></a></p>
<p>Roche, the Swiss headquartered pharmaceutical giant, has been taken up the top positions of R&amp;D expense for a few years. The R&amp;D departments are mainly gRED in Basel and gRED in California. It also improves its R&amp;D line through cooperation. Recently, Roche reached an agreement with Bristol-Myers Squibb to co-develop adnectin, a drug used to treat duchenne muscular dystrophy (DMD). In the cooperation, Roche needs to pay $170 million in advance, and $205 million follow-up project support costs.</p>
<p>At present, Roche already has several blockbuster products in product line. In March of this year, FDA approved Roche’s monoclonal antibody drug Ocrevus (<span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Anti-CD20-Therapeutic-Antibody-ocrelizumab-327.htm" target="_blank">ocrelizumab</a></strong></span>) for relapsing multiple sclerosis (RMS) treatment and primary progressive multiple sclerosis PPMS) treatment. The outside world commented that this drug had the potential to change the treatment pattern of multiple sclerosis, and were optimistic about its future prospects. Last year, Roche also introduced the dominant PD-L1 inhibitor tecentriq.</p>
<p>With today’s situation where drug combination strategy wins the market, the success of a drug can lead to a variety of follow-up strategies, just like Roche&#8217;s Phase III clinical trials of combination drug that is in progress at this moment. It was found by comparing that the combination scheme of combing Perjeta (ER2/neu receptor antagonist) and <strong><span style="color: #0000ff;"><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Anti-Human-ErbB2-Therapeutic-Antibody-trastuzumab-13489.htm" target="_blank">Herceptin</a></span></strong> did better than traditional treatment for early stage post-operative breast cancer patients in reducing mortality and relapse rates.</p>
<p>It was noted that the success of the clinical trial will further strengthen Roche&#8217;s position in the field of tumors. In addition, Roche&#8217;s Alecensa also defeated Pfizer&#8217;s Xalkori in competing for the top position of treating ALK+ lung cancer.</p>
<p>Roche also expects emicizumab to make great achievements in the treatment of hemophilia. However, taking into account the death of the Phase III clinical trial and a series of side effects, the outside world begins to doubt the safety of this drug.</p>
<p>In the field of Alzheimer&#8217;s disease treatment, the failure of <span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Anti-Human-Abeta-Therapeutic-Antibody-Gantenerumab-13704.htm">Gantenerumab</a></strong></span> is regrettable, while it also urges people to think about how much we know about AD.</p>
<p>2. Merck</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/merk.png"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-1075" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/merk.png" alt="merk" width="605" height="47" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/merk.png 605w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/merk-300x23.png 300w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/merk-604x47.png 604w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/merk-600x47.png 600w" sizes="(max-width: 605px) 100vw, 605px" /></a></p>
<p>&nbsp;</p>
<p>To say Merck’s R&amp;d director Roger M. Perlmutter saved Merck’s R&amp;D line may be overstating, but he did stop Merck from missing the blockbuster drug keytruda. After staying in the market of cancer immunization, Merck began to expand the application rang of keytruda. There are currently more than 10 keytruda-based clinical Phase III research are in progress.</p>
<p>Ertugliflozin, co-developed by Merck and Pfizer, is in the process of approving by Europe and the United States. Taking into account its good performance in Phase III clinical trial, these two pharmaceutical companies should have a good expectation to the drug.</p>
<p>Merck’s biggest setback in last year is the failure of Verubecestat targeting for mild to moderate Alzheimer&#8217;s disease in Phase III clinical trial. Currently, there is no company that can break the curse of AD drug research and development.</p>
<p>Merck doesn’t seem to keen to it in terms of acquisition. It spent $95 million in the acquisition of Israel&#8217;s cCAM, trying to stabilize its position in the field of immune tumors by acquiring the company&#8217;s product line. However, it failed in Phase I clinical trial.</p>
<p>3. Novartis</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/novertis.jpg"><img decoding="async" loading="lazy" class="aligncenter wp-image-1076 size-full" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/novertis.jpg" alt="Novartis" width="606" height="51" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/novertis.jpg 606w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/novertis-300x25.jpg 300w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/novertis-604x51.jpg 604w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/novertis-600x51.jpg 600w" sizes="(max-width: 606px) 100vw, 606px" /></a></p>
<p>Novartis’ kisqali was approved by the FDA at the beginning of 2017. Kisqali (ribociclib,formerly known as LEE011) was combined with aromatase Inhibitors as an initial endocrine regimen for female patients with HR-positive, HER2-negative advanced or metastatic breast cancers. With excellent clinical data, it is expected to have an annual sale of $2.5 billion.</p>
<p>The clinical study of Psoriasis IL-17 blockers new drug Cosentyx shows better results than similar products. Along with Johnson &amp; Johnson&#8217;s Stelara and Amgen’s Enbrel, it is expected to replace their blockbuster drug position in the future.</p>
<p>Zykadia (Ceritinib) was also given priority in the treatment of ALK+ non-small cell lung cancer recently as well as breakthrough therapy designation in lung cancer brain metastases.</p>
<p>In contrast, the FDA&#8217;s positive attitude towards CAR-T should be Novartis&#8217; most pride of this year. As a pioneer of CAR-T, its CTL019 will also be a blockbuster drug.</p>
<p>The field of cardiovascular disease will no longer be a specialty of Novartis after the Entresto patent expires. Entresto&#8217;s sales having been poor, serelaxin’s failure in clinical trial and competitors already exists in this field are all challenges to Novartis’ strength in the field of cardiovascular.</p>
<p>Maybe the huge market in the field of cardiovascular is taken into account, Novartis has never given up this field. In 2016, it reached an agreement with Ionis by $1.65 billion to co-develop two cardiovascular drugs.</p>
<p>Novartis made a series of adjustments to the company&#8217;s structure by the end of 2016, which is also the highly efficient way of running Novartis in facing the declining revenue &#8211; optimizing the structure and layoffs, including disbanding the company&#8217;s cell and gene therapy sector.</p>
<p>4. Pfizer</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/pfizer.jpg"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-1077" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/pfizer.jpg" alt="pfizer" width="609" height="47" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/pfizer.jpg 609w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/pfizer-300x23.jpg 300w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/pfizer-604x47.jpg 604w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/pfizer-600x47.jpg 600w" sizes="(max-width: 609px) 100vw, 609px" /></a></p>
<p>In 2010, when Pfizer’s CEO was still Ian Read, the company did not have too many research projects. Relying on the company&#8217;s strong financial resources, Ian Read established a R&amp;D product line through acquisitions.</p>
<p>The immune checkpoint project <span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Avelumab-67640.htm" target="_blank">Avelumab</a></strong></span> co-developed with Merck (Germany) is one of them. It was officially approved for the treatment of metastatic megal cell carcinoma patients who had received at least one course of chemotherapy this year.</p>
<p>Pfizer spent $295 million working with Opko to co-develop long-acting growth hormones. However, the phase III clinical trial result released in October last year was a failure.</p>
<p>5. Johnson &amp; Johnson</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/jonsonjonson.jpg"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-1078" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/jonsonjonson.jpg" alt="jonson&amp;jonson" width="608" height="53" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/jonsonjonson.jpg 608w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/jonsonjonson-300x26.jpg 300w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/jonsonjonson-604x53.jpg 604w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/09/jonsonjonson-600x53.jpg 600w" sizes="(max-width: 608px) 100vw, 608px" /></a></p>
<p>Johnson &amp; Johnson is quite special in the list. This company is consisted of three segments, including pharmaceuticals, consumer goods and medical equipment, but it is quite a large value considering only its investment in drug R&amp;D.</p>
<p>Johnson &amp; Johnson is actively working with small businesses around the world in order to expand its business fields. Perhaps there may be surprises. In March 2010, Johnson &amp; Johnson published the Phase III clinical study of IL-23 monoclonal antibody <span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Anti-IL23A-Therapeutic-Antibody-guselkumab-13576.htm" target="_blank">Guselkumab</a></strong></span> for the treatment of moderate to severe plaque psoriasis. Although the drug R&amp;D progress is slow, it was worthwhile from the results.</p>
<p>Multiple myeloma drug darzalex has been regarded as a potential blockbuster drug by the industry, but Johnson &amp; Johnson has a conservative valuation for this drug. Johnson &amp; Johnson itself does not deny that Guselkumab and <span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Anti-Human-IL6-Therapeutic-Antibody-Sirukumab-13575.htm" target="_blank">Sirukumab</a></strong></span> will take up dominant position in the future.</p>
<p>Humira is still the global sales champion currently, so rheumatoid arthritis has been a major field for pharmaceutical companies. Johnson &amp; Johnson&#8217;s sirukumab is one of them. While, the feedback (due to security issues, the jury voted down its approval by 12:1) of recent FDA expert jury showed that this idea might probably be stranded.</p>
<p>The result of the clinical trial of antidepressant drug Esketamine will soon be published. Johnson &amp; Johnson acquired Apalutamide for the treatment of non-metastatic ovariasis against prostate cancer in 213. It is unknown whether Apalutamide will bring new dominant drugs for it after spending so much money in the acquisition.</p>
<p>Johnson &amp; Johnson&#8217;s R&amp;D line is in good condition. Of course, just like other pharmaceutical giants, acquisition is a good solution when their development reached the period of stagnation, Johnson &amp; Johnson, for instance. It spent $30 billion in the acquisition of Actelion this year, so as to enter the arterial hypertension market.</p>
<p>Next: <span style="color: #0000ff;"><strong><a style="color: #0000ff;" href="http://www.creative-biolabs.com/blog/index.php/top-10-rd-expense-of-pharmaceutical-giants-ii">Top 10 R&amp;D Expense of Pharmaceutical Giants (II)</a></strong></span></p>
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		<title>A Quick View of the Global R&#038;D Situation of EGFR Drugs</title>
		<link>https://www.creative-biolabs.com/blog/index.php/situation-of-egfr-drugs/</link>
					<comments>https://www.creative-biolabs.com/blog/index.php/situation-of-egfr-drugs/#comments</comments>
		
		<dc:creator><![CDATA[biolabs]]></dc:creator>
		<pubDate>Thu, 27 Jul 2017 04:07:59 +0000</pubDate>
				<category><![CDATA[Antibody Engineering Research]]></category>
		<category><![CDATA[antibody drug]]></category>
		<category><![CDATA[biosimiar]]></category>
		<category><![CDATA[drug patent]]></category>
		<category><![CDATA[egfr-targeted drug]]></category>
		<category><![CDATA[Therapeutic Antibody]]></category>
		<guid isPermaLink="false">http://www.creative-biolabs.com/blog/?p=913</guid>

					<description><![CDATA[1. There are 102 EGFR-targeted drugs that are approved globally and in clinical research in total. Up to now, there are 20 EGFR-targeted drugs approved by the global market (Europe, USA, Japan,<a class="moretag" href="https://www.creative-biolabs.com/blog/index.php/situation-of-egfr-drugs/">Read More...</a>]]></description>
										<content:encoded><![CDATA[<p>1. There are 102 EGFR-targeted drugs that are approved globally and in clinical research in total.</p>
<p>Up to now, there are 20 EGFR-targeted drugs approved by the global market (Europe, USA, Japan, South Korea, etc.), 80 in clinical application and research stage, and 2 in NDA application.</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug1.png"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-914" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug1.png" alt="EGFR-targeted drugs" width="590" height="327" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug1.png 590w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug1-300x166.png 300w" sizes="(max-width: 590px) 100vw, 590px" /></a></p>
<p>2. EGFR-targeted drugs are mainly small molecule inhibitors.</p>
<p>Molecular targeting drugs developed for EGFR are divided into two major categories:</p>
<p>1) There are 18 monoclonal antibodies, such as <strong><span style="color: #0000ff;"><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Cetuximab-32082.htm" target="_blank">cetuximab</a></span></strong> and <strong><span style="color: #0000ff;"><a style="color: #0000ff;" href="http://www.creativebiolabs.net/Panitumumab-22418.htm" target="_blank">panitumumab</a></span></strong>. They can bind to EGFR extracellular region and block ligand-dependent EGFR activation.</p>
<p>2) There are 68 small molecule inhibitors, including small molecule multi-target receptor tyrosine kinase (RTKs) Inhibitors and small molecule tyrosine kinase inhibitors (EGFR-TKls), which can inhibit tyrosine kinase’s activity in EGFR intracellular region.</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug21.png"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-916" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug21.png" alt="Small molecule inhibitors" width="380" height="219" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug21.png 380w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug21-300x173.png 300w" sizes="(max-width: 380px) 100vw, 380px" /></a></p>
<p>3. 9 EGFR small molecule inhibitor drugs are approved.</p>
<p>1) AstraZeneca has 3 approved drugs, occupying one third of the global market.</p>
<p>2) The approved EGFR small molecule inhibitors are mainly sued for the treatment of non-small cell lung cancer.</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug3.png"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-917" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug3.png" alt="9 EGFR small molecule inhibitor drugs are approved" width="746" height="483" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug3.png 746w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug3-300x194.png 300w" sizes="(max-width: 746px) 100vw, 746px" /></a></p>
<p>3) In the United States, there are 8 approved EGFR small molecule inhibitor drugs which have patent protection. Gefitinib is confronting with patent cliff.</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug4.png"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-918" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug4.png" alt="8 approved EGFR small molecule inhibitor drugs" width="573" height="334" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug4.png 573w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug4-300x175.png 300w" sizes="(max-width: 573px) 100vw, 573px" /></a></p>
<p>&nbsp;</p>
<p>4. 4 EGFR-targeted monoclonal antibodies are approved.</p>
<p>1) Antibody class EGFR-targeted drugs are mainly used for the treatment of rectal cancer, head and neck cancer.</p>
<p>2) Eli Lilly has 2 approved drugs, dominating the EGFR monoclonal antibody market.</p>
<p>3) Cetuximab is the champion of the year, with sales twice as much as panitumumab of the same indication.</p>
<p><a href="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug-6.png"><img decoding="async" loading="lazy" class="aligncenter size-full wp-image-919" src="http://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug-6.png" alt="4 EGFR-targeted monoclonal antibodies are approved." width="693" height="481" srcset="https://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug-6.png 693w, https://www.creative-biolabs.com/blog/wp-content/uploads/2017/07/egfr-drug-6-300x208.png 300w" sizes="(max-width: 693px) 100vw, 693px" /></a></p>
<p><strong>Notes:</strong> The global sales showed in the histogram are the original sales of the relevant company. The above data was retrieved on July 12, 2017.</p>
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