In 2015 the first biosimilar was approved in the U.S., and there are more than 50 biosimilars on the way. Everyone involved—health care providers, payers, regulators, policymakers, patient advocates, and patients—needs a source of clear, unbiased, evidence-based information to better understand biosimilars and make wise decisions on policy and use.
This overview covers what biosimilars are, how they may be developed and manufactured, the regulatory procedures around approval and use, and how they will be used to expand treatment options for U.S. patients. The FAQs contain answers to the most common questions people have about biosimilars.
Top Three Reasons Biosimilars Are as Safe as Reference Biologics
Biosimilars are not generics—they are highly similar versions of biologic medicines, which by their nature, are difficult to reproduce exactly (even within one manufacturing facility). However, physicians and patients should feel confident that the U.S. regulatory pathway for biosimilars ensures the following:
1 Biosimilars are designed to match the structure and function of the reference biologic with an identical amino acid sequence and an indistinguishable three-dimensional shape.
2 The FDA approves biosimilars based on the same high standards for manufacturing and quality used for all biologics.
3 Patients can be assured that FDA-approved biosimilars have the same safety and efficacy profile as their reference biologics