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View metadata, citation and similar papers at core.ac.brought to you byCOREprovided by Carolina Digital Repository U.S. BIOSIMILAR MARKET: ONGOING POLICY CHALLENGES AMONG KEY HEALTH CARE STAKEHOLDERS
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The Form US biosimilar market refers to the regulatory framework established by the FDA for the approval and monitoring of biosimilar products, which are biologics highly similar to an already approved biological product.
Manufacturers of biosimilars are required to file the necessary forms with the FDA as part of the application process for biosimilar approval.
To fill out the form for the US biosimilar market, manufacturers must provide detailed information about the biosimilar product, its formulation, and data demonstrating its similarity to the reference biologic product.
The purpose of the form in the US biosimilar market is to facilitate the FDA’s evaluation process for biosimilar products, ensuring they meet safety, efficacy, and quality standards comparable to their reference products.
The form must report information including product characterization, analytical data, clinical data, manufacturing processes, labeling, and post-market surveillance plans.
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