The Alliance for Safe Biologic Medicines urges the FDA to adopt "steps to ensure patient safety is at the forefront of the biosimilars pathway." Further, the FDA needs to "make clear that clinical studies will be necessary for the foreseeable future due to the complexity and diversity of human biology and the limits of scientific knowledge today." The Alliance is a trade organization composed of biopharma companies and individuals that has set up to advise the FDA on biosimilars policy while it is under discussion (i.e. a trade lobby). Company's like Novo Nordisk and Roche (Genentech) are members. See in-Pharma Technologist and Fierce Biotech here and here.
They appear to be asking the FDA to make its proposed regulations less flexible than they are currently written and to impose more strict guidelines requiring clinical trials, as well as sterner traceability measures and a pharmacovigilance system that "distinguishes a biologic reference product from its biosimilar."
I've written before that I think delay tactics to make it harder to get biosimilars to the market (and at a higher cost) are so much whistling past the graveyard (see blog post). To me, the economic and government forces favoring the implementation of biosimilar guidelines and subsequent approval of these products is a given. Governments want to save on healthcare costs, it's that simple. Will they compromise safety to do so? No. But, I think they will try to set up flexible approval systems that give the regulatory bodies some latitude to approve some biosimilar applications faster than others with more or less clinical data support needed depending on the situation. The FDA seems to be giving itself some flexibility.
I don't see innovators trying to delay implementation and market competition as a very effective strategy. It's ironic that many of the innovators themselves are likely to be among the first biosimilar applicants (with a competitor's drug of course). I'm further amused that many of these same companies are simultaneously in favor of other legislative efforts underway (FAST, TREAT, etc.) to speed the drug approval process. In that instance, they've suggested only safety data is needed and a "case by case" consideration of drug licenses -- particularly for diseases without other good treatment options -- is just the way to go (see blog posts here and here).
I think we should get on with it. Get biosimilar guidelines in place and get the process toward approval started. Biosimilars ARE coming. If innovators want to be innovators, then innovate. If they want to be biosimilar competitors, then compete -- but don't block or slow the process down.
Posted by Bruce Lehr Apr 18th 2012.