FDA approves the 25th biosimilar drug to continue to promote the availability of biological products

On November 18, New York local time, Pfizer announced that the FDA had approved the listing of its declared abrila Da (adalimumab afzb) Abrilada is a biomaterial of Humira (adalimumab) With the approval of the drug, Pfizer has 6 approved biomaterials, becoming one of the companies with the largest portfolio of biomaterials Prior to the approval of abrilada, Dr Sarah Yim, acting director of the office of biological products and similar drugs of FDA drug review and Research Center (CDER), issued a public statement, saying that FDA will continue to promote the competition of biological products, and introduced a series of important work carried out by FDA in the review of biological similar drugs The following is the full text of Dr Yim's statement Biological products play a more and more important role in modern medicine, providing an effective treatment for a variety of serious diseases These biological products developed by advanced technology usually come from natural or organic bodies, such as animal and plant cells; some come from microorganisms, such as bacteria or yeast Compared with small molecule drugs, biological products are more complex, especially in the treatment of cancer and autoimmune diseases, such as rheumatoid arthritis, psoriasis and inflammatory enteritis Historically, there was no simplified FDA review approach to bring "follow-up" biological products to the market, so there was a lack of effective competition in the biological products market In 2010, Congress authorized FDA to carry out simplified approval channels for biological similar drugs and interchangeable biological products, which changed the situation of lack of effective competition The approval channel of biological analogues authorizes FDA to review and approve biological analogues; these products can provide more treatment channels for patients and reduce treatment costs Similar biological drugs are highly similar to FDA approved biological products (referred to as reference biological products), and there is no significant difference in clinical FDA's ability to support the launch of safe and effective biologicals is critical for patients and healthcare systems Data source: reference [2] The FDA approved biomimetic drug abrila Da (adalimumab afzb) of Humira to further promote the competition of biological products This approval is the 9th biological similar drug approved by FDA in 2019, and the total number of biological similar drugs approved by FDA is 25 I am very pleased to see this progress and am confident that the market for these therapeutic drugs will continue to grow So far, the FDA's development plan for bioequivalent drugs has registered 74 plans for 38 different reference biological products The detailed discussion on the development of these bio similar drugs and interchangeable products will lay the foundation for the continuous market competition ▲ up to now, 25 biosimilar drugs approved by FDA (data source: reference [3], charted by content team of Wuxi apptec, click the picture to view the large picture) It is important that healthcare professionals and patients can fully rely on these approved products when using FDA approved bioequivalent drugs The biological similar drugs approved by FDA are subject to strict review to determine whether they meet the licensing requirements and are manufactured according to the same quality standards as the brand drugs FDA also continued its work in accordance with the action plan for bioequivalent drugs to improve the efficiency of the development and approval process for bioequivalent drugs and interchangeable products These efforts include the development and implementation of new templates dedicated to the review of bioequivalent drugs, and the development and validation of pharmacodynamic biomarkers tailored for the development of bioequivalent drugs According to the plan, we will continue to be developers of biological similar drugs and further clarify it from the perspective of science and regulations; at the same time, we will carry out communication and publicity work to improve patients' awareness of biological similar drugs, so that clinicians and payers can better understand the safety and effectiveness of biological similar drugs ▲ FDA approved reference biological products of similar biological drugs (data source: reference [3], content team drawing of Wuxi apptec, click the picture to view the large picture) Another important work of FDA in the field of biological analogues is that under the guidance of the U.S Congress, FDA will, in the past, comply with the federal food, drug and Cosmetics Act, The biologics approved by the FD & C act are transformed into biologics approved by the public health service act This work will take effect on March 23, 2020, and FDA is trying to promote this work Such conversion means that these biological products, including insulin and other products with high demand and rising price, will be subject to the regulation of PHS act as other biological products, and open to competition for biological similar drugs On the other hand, such a transformation may lead to the development of more affordable bio similar drug products, including products that can be interchanged with brand insulin; such products will not have any compromise in terms of safety and effectiveness In May this year, the FDA held a public hearing on the development of bioequivalent drugs and interchangeable insulin products We are analyzing suggestions and opinions from different stakeholders, including those who are directly affected by the pricing of insulin, and those who will benefit from the competition of bioequivalent drugs and interchangeable insulin products The conversion is in progress and is a high priority In terms of providing opportunities for increasing access to important therapies, there is great hope that biological analogues and interchangeable biological products will be provided, and FDA will do its best to promote competition in this field [1] Sarah Yim Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product Nov 15, 2019 Retrieved Nov 19, 2019 from https://www.fda.gov/news-events/press-announcements/statement-sarah-yim-md-acting-director-office-therapeutic-biologics-and-biosimilars-fdas-center-drug [2] FDA BIOSIMILARS ACTION PLAN: Balancing Innovation and Competition July 2018 Retrieved Nov 19, 2019 from https://www.fda.gov/media/114574/download [3] Judith Stewart How many biosimilars have been approved in the United States? Nov 18, 2019 Retrieved Nov 19, 2019 from https://www.drugs.com/medical-answers/many-biosimilars-approved-united-states-3463281/ [4] Pfizer FDA APPROVES PFIZER’S BIOSIMILAR, ABRILADA Gamma (ADALIMUMAB-AFZB) FOR MULTIPLE INFLAMMATORY CONDITIONS Nov 18, 2019 Retrieved Nov 19, 2019 from https://investors.pfizer.com/investor-news/press-release-details/2019/FDA-Approves-Pfizers-Biosimilar-ABRILADA-adalimumab-afzb-for-Multiple-Inflammatory-Conditions/default.aspx A kind of