UPDATE (21 February) – Here is a decent video interview of Rachel Sherman, head of the Office of Medical Policy for the FDA, on the Biosimilar guidelines:
Today we add the 351(k) pathway for product development, joining 505(b)(2), 510(k), and others. Yes, its the draft guidelines for biogenerics from the US FDA:
“When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers.”
The press release lists three documents for our consideration:
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Flipping through this PDF, one of the key statements is:
The sponsor of a proposed product must include in its submission to FDA information demonstrating that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
While this sounds like an NDA, it’s not really a surprise. Long-time observers of these guidance documents have speculated that any US legislation will include “no clinical difference” language. We also note (again, not surprisingly) that clinical immunogenicity will be required.
Quality Considerations…: This document is the CMS piece of the draft guidelines. We don’t see any real surprises here. There are requirements for physicochemical characterization, as well as functional characterization (including receptor binding).
Q&A: This document makes interesting statements regarding Exclusivity.
There are really no surprises here. It still looks like the 351(k) pathway will remain limited to companies who can afford to conduct these clinical trials. Therein lies a potential conundrum. If 351(k) products have to be priced at a minimal discount to the brand, will they actually become affordable?