WASHINGTON The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent and scientific regulatory structure; and enable innovation and competition when creating regulations governing follow-on biologics, according to testimony released in advance of an FDA hearing by a drug lobbying group.
The Pharmaceutical Research and Manufacturers of America will testify Wednesday at the FDA’s public hearing on the implementation of the approval pathway for follow-on biologics that was included in the healthcare-reform bill. PhRMA’s testimony also included statements about biosimilarity, interchangeability and other topics.
The hearing began Tuesday morning and includes testimony from numerous interested organizations and companies.
The healthcare-reform bill, passed late last year, includes provisions for a regulatory approval pathway for follow-on biologics, also known as biosimilars, knock-off versions of biotech drugs. The bill allows for 12 years of data exclusivity for innovator biologics, meaning that the FDA would have to wait that long before it could grant approval to biosimilar versions — compared with generic pharmaceutical drugs, for which the exclusivity period is five years.
Also unlike generic drugs, it is difficult and often impossible to characterize, or fully map out, the chemical structures of biotech drugs and the mechanisms by which they work, hence the use of the term “biosimilars.” What this means is that subtle differences in biosimilars resulting from genetic differences in the cells used to create them could cause them to affect the body differently from the originals on which they’re based, thus requiring a more complex approval process that may include clinical trials.