Today, FDA issued a draft guidance with questions and answers (Q&As) related to development and licensure of biosimilar and interchangeable biological products.
The “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act” draft guidance provides up-to-date, development-related guidance to biosimilars sponsors and other stakeholders on discrete issues that do not warrant a “full” guidance document. The Q&As in this guidance, when finalized, will be added as a revision, to the final guidance document Questions and Answers on Biosimilar Development and the BPCI Act, as appropriate. The draft guidance released today provides new Q&As and does not replace the draft guidance document entitled, “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2). FDA believes that guidance for industry that provides answers to commonly asked questions regarding FDA’s interpretation of the BPCI Act will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products. These draft Q&A’s on interchangeability are designed to provide clarity for developers who want to demonstrate that their proposed biological product meets the statutory interchangeability standard under the Public Health Service Act.
These Q&A guidance documents are part of a series of guidance documents that FDA has developed to facilitate development of biosimilar and interchangeable products and they are another step we’re taking to provide increased regulatory certainty and predictability for stakeholders, including prospective applicants engaged in the development of interchangeable biosimilar products. This draft guidance will help promote competition in the biological product market by providing advice on the pathway for “interchangeable” biological products, such as a proposed interchangeable insulin, which may be substituted without the involvement of the prescriber subject to state law, similar to how generic drugs can be substituted for brand name drugs prescribed for patients.
Increased competition from biosimilar and interchangeable products can help bring down the costs of biological products, improving patient access to important therapies.
Download the complete guidance document from https://www.eventura.world/documents