- Today, the FDA issued a new statement on low-cost bio generics and interchangeable protein products, including every insulin currently on the market.
- In today’s statement, the FDA said that starting March 2020, most protein products approved as drug products will face competition from biosimilars and interchangeable products.
- Original statement:
- 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.
Today, the FDA issued a new statement on low-cost bio generics and interchangeable protein products, including every insulin currently on the market.
Insulin is a life-saving drug that many Americans use to treat diabetes. However, in recent years, the rising price of insulin products has caused many patients to worry about the ability to obtain insulin for survival. It is understood that FDA has held a public hearing to listen to the opinions of stakeholders. FDA is also preparing to submit and review the applications for 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 patients with diabetes.
Last month, the FDA issued the statement on improving the efficiency of the development of bio generics and interchangeable insulin products The statement aims to help more patients with diabetes to obtain better treatment methods. It also explains the guidance notes of clinical immunogenicity of biologically similar or interchangeable insulin products Case.
In today’s statement, the FDA said that starting March 2020, most protein products approved as drug products will face competition from biosimilars and interchangeable products.
However, “chemosynthetic peptides” are excluded from this transformation, which means that products belonging to the category of “chemosynthetic peptides” will not be able to enter the market as biological imitations or interchangeable products, and must enter the market in different ways from the former two.
Such products will also not be able to enter the market through generic drugs, as the original products will be classified as biological agents. This exclusion may undermine the competitiveness of such products, because it means that if a developer synthesizes a generic of a protein product (such as an insulin generic) by chemical means, the product will not be able to enter the market through bio generic or interchangeable channels, but will have to submit a new drug application, which may require more resources.
The original FDA has this restriction, that is, chemically synthesized peptides can not be listed as biological analogues or “biological interchanges”, nor can they go through the generic drug application path. Instead, they have to go through separate approval. This kind of restriction is a kind of harm to the market and competition, resulting in the medicine can not be used. So now the restrictions are lifted.
The FDA is trying to better help patients use more drug options, regardless of the manufacturing method. Moreover, FDA believes that it can promote the innovation and progress of production process and method, which is beneficial to the society.
Ultimately, the FDA’s approach to increasing the cost of these products to the U.S. market is an effective way to increase the cost of these products for both patients and biopharmaceuticals.
Original statement:
Statement on low-cost biosimilar and interchangeable protein products
Statement From:Deputy 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, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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