Safety & Sameness
Over the last decade, the E.U. monitoring system for safety concerns has not identified any relevant difference in the nature, severity, or frequency of adverse effects with biosimilars and their originator biologic medicines. In addition to the years of manufacturers’ and patients’ safe experience with these therapies in Europe, Americans can rely on strict scientific scrutiny by the FDA to ensure the safety of biosimilars.
The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, created an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCIA). Under the BPCIA, 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. The FDA has made it clear that approved biosimilars, like all chemical and biologic medicines, must be held to a very high standard and that interchangeable biologics will meet additional requirements in keeping with BPCIA provisions.
The FDA currently uses state-of-the-art science to review and approve biologics. The FDA’s extensive expertise and in-depth understanding of biologic products is applied to biosimilars, which are evaluated based on many of the same scientific principles and “highly similar” analytical standards applied to all biologics.