FDA re issued a statement on low-cost biosimilars: chemically synthesized peptides are no longer excluded!

Today, the FDA reissued a statement on low-cost biosimilars and interchangeable protein products, including every insulin currently on the market Insulin is a life-saving drug used by many Americans to treat diabetes However, in recent years, the rising price of insulin products has caused many patients' serious concerns about the ability to obtain insulin needed for survival It is understood that FDA has held a public hearing to listen to the opinions of stakeholders, and FDA is also preparing to submit and review the applications of bio generic drugs and interchangeable insulin products According to the FDA, once approved, these products will bring new competition to the insulin market and help provide affordable treatment options for diabetics Last month, the FDA issued the statement on improving the development efficiency of bio generic and interchangeable insulin products (please refer to https://mp.weixin.qq.com/s/bc18apsqlzju5uolu5rn1q), which is to help more diabetic patients get better treatment methods, and also explains the guidance of "precautions for clinical immunogenicity of bio similar or interchangeable insulin products" Case In today's statement, the FDA said that from March 2020, most of the protein products approved as drug products will face competition from bio generic and interchangeable products However, "chemically synthesized polypeptides" are excluded from this transformation, which means that products belonging to the category of "chemically synthesized polypeptides" will not enter the market as biological imitations or interchangeable products, and must enter the market in different ways than the first two Such products will also not be able to enter the market through generic approaches, as the original products will be classified as biological preparations This exclusion could undermine the competitiveness of such products, because it means that if developers synthesize a generic protein product (such as insulin generic) by chemical methods, the product will not be able to enter the market through bio generic or interchangeable ways, but must submit a new drug application, which may require more resources FDA said the "chemically synthesized polypeptides" generic product will help patients, because it provides a more effective and simplified way for the subsequent insulin and other protein products chemically synthesized, and improves the market potential In addition to expanding access to low-cost biosimilars and interchangeable protein products, the "chemically synthesized polypeptides" type of generic products will help promote potential innovation in manufacturing methods, which may enhance the efficiency of future manufacturing processes These measures are to ensure an effective way for FDA to bring potential low-cost bio generic drugs and interchangeable protein products to the market, expand the access and competition of these products, and ultimately help American patients Statement on low cost biosimilar and exchangeable protein products statement from: Department Commissioner for policy, legislation, and International Affairs - Food and Drug Administration Anna Abram Director - Center for Drug Evaluation and Research Janet Woodcock M.D   Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients In March 2020 most protein products that were approved as drug products (including every insulin currently on the market) will open up to biosimilar and interchangeable competition However, “chemically synthesized polypeptides” are excluded from this transition, which means that a product that falls within this category won’t be able to come to market as a biosimilar or interchangeable product, but will have to come to the market under a different pathway Such a product would also not be able to come to market through the generic drug pathway because the originator product will have been classified as a biologic, and will not be available for copying This exclusion could hurt potential competition because it means that if a developer were to chemically synthesize a copy of a protein product (e.g., an insulin copy), the product would not be able to come to market through the abbreviated biosimilar or interchangeable pathway, but instead would have to submit a new drug application, which could be much more resource-intensive Removing this exclusion will help patients because it provides the potential for chemically synthesized follow-on insulins and other protein products to come to market through more efficient abbreviated pathways, regardless of how they are manufactured In addition to expanding access to lower-cost biosimilar and interchangeable protein products, removing this exclusion will help to promote potential innovation in manufacturing methods, which could lead to future efficiencies in manufacturing processes The FDA, an agency within the U.S Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices The agency also is responsible for the safety and security of our nation’s food supply, The original text: http://suo.im/6xdchu Jennie turtle states that: This article only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.