Biogenerics Are Happening: Slowly, Product-By-Product
This article was originally published in RPM Report
FDA's guidance on biogenerics is on the backburner: Congress is showing little interest in pushing the agency towards them. But some follow-on products are already making it to the market.
You may also be interested in...
It isn’t a 351K pathway drug, but it does set up an interesting comparison for sponsors using the formal biosimilar pathway compared to the 505(b)(2) NDA route.
A Transparency Case Study: Horizant Approval for RLS Offers Window Into Complexity of Complete Response Disclosures
The rejection of XenoPort’s restless leg syndrome therapy in February 2010 shocked investors, and so did the April 2011 approval of the application after a nifty piece of regulatory re-engineering by the sponsors. Would public release of the CR letter have helped investors handicap the prospects? That seems unlikely in this case.
FDA is open for business on biosimilars as it works out the specifics of the new review pathway. But for companies considering an entry into the space, two big questions still remain: Does a profitable market exist, and how conservative will FDA be on those initial approvals? Executives from across the biopharmaceutical industry weigh in during The RPM Report’s FDA/CMS Summit.