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Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product.

Products that are proven to be highly similar to previously licensed biological medicines are referred to as “biosimilars”. A legal and regulatory framework has been implemented in Europe to create an abbreviated registration process for biosimilars. This has enabled the approval of several products that provide patients and healthcare authorities with more cost-effective options for proven safe and effective therapies. 

How are biosimilars approved?

Biosimilars were created under the Biologicals Price Competition and Innovation Act (BCPI) of 2009 and signed into law through The Patient Protection and Affordable Care Act (Affordable Care Act) on March 23, 2010. The BCPI Act created an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed (approved) biological product.
Under this law, a biological product may be demonstrated to be biosimilar if data show that, among other things, the product is highly similar to an already-approved biological product, also called the reference product, and has no clinically meaningful differences in terms of safety, purity, and potency from the reference product. Therefore, the biosimilar approval relies on the agency’s previous findings that the FDA-approved reference product is safe and effective.

Source: FDA:


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