Biosimilars Handbook

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.

“The high standards for approval of biosimilar and interchangeable products mean that patients and health care professionals can be assured that when those products go to market, they will meet the standards of safety, efficacy and high quality that everyone expects and count on. Efforts to undermine trust in these products are worrisome and represent a disservice to patients who could benefit from these lower-cost treatments.”

Margaret Hamburg, M.D.
Former U.S. FDA Commissioner

The highly similar regulatory standard is conceptually the same standard currently applied to brand biologics undergoing manufacturing changes—a showing of similarity between batches of active ingredients before and after the change. This enables the FDA to conclude that the new batches have no clinically meaningful difference and they retain the same safety as the product before the change was made. Any FDA-approved biosimilar is within the acceptable range of variability observed between batches of the original reference product.

FDA-approved biosimilar medicines meet scientific and clinical criteria and go through rigorous analysis. Patients, doctors and others can be assured that biosimilars are safe, effective, high-quality alternatives to costly brand biologic drugs.