Table of Contents
WASHINGTON — The Biosimilars Council, a division of the Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, published a new position paper outlining the benefits of updating the existing Food and Drug Administration regulatory process for biosimilar medicines. Biosimilars – medicines derived from living cells that are highly similar to and have no meaningful clinical difference from previously approved biologics – are used to treat a variety of diseases including cancer, rheumatoid arthritis, and irritable bowel disease.
Changes would allow for the elimination of unnecessary regulatory requirements when data demonstrates no clinical meaningful difference between the biosimilar and its biologic reference product.
“The time is now to update and streamline the current regulatory model for biosimilars,” said Craig Burton, Executive Director for the Biosimilars Council. “Around 80 percent of biologics currently do not have a biosimilar product in the works. Let’s reduce that percentage and pave the way for a new generation of lower-cost medications.”
In the position paper, the Biosimilars Council urges the following changes:
Eliminate unnecessary clinical efficacy studies.
To reduce the costs and risks of biosimilar development and encourage industry investment in biosimilars, FDA should clarify in regulations and/or guidance that requests for clinical efficacy studies should be the exception rather than a generally applied rule and explain the limited circumstances in which they might be scientifically justified. FDA should discourage the conduct of comparative efficacy studies when analytical, functional, and PK methodologies are sufficient to detect clinically meaningful differences.
Establish global regulatory comparators to support demonstration of biosimilarity. FDA should work with other regulatory authorities to establish global comparators that would eliminate the need for duplicative PK testing of reference products from different regions of the world to support the requirements of various health regulatory authorities when sponsors seek to use data comparing a proposed product with a non-U.S.-approved comparator product to support a demonstration of biosimilarity.
In 2010, Congress passed the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) as part of the Patient Protection and Affordable Care Act. The BPCIA created an initial abbreviated licensure pathway for biosimilar medicines in the U.S. Since 2015, biosimilars have been used in nearly 700 million days of critical patient therapy and have saved U.S. patients and the healthcare system around $24 billion.
Recommendations included in the position paper will not lower safety, efficacy, or quality standards; nor will they involve an extensive revision of the existing regulatory framework related to biosimilars. The Biosimilars Council does not seek to eliminate clinical efficacy studies altogether—emphasizing the FDA’s authority to request additional evidence in exceptional circumstances where scientifically-justified, risk-based considerations are evident.
