Multiple sources indicate that FDA is close to releasing an initial draft guidance on biosimilar products. Last Friday, Reuters reported that Janice Soreth, deputy director of the FDA's Europe office in London, stated that FDA might release the guidance "as early as the next few weeks, maybe even days." Soreth made the comments at Windhover's Pharmaceutical Strategic Alliances Conference in New York. Soreth's comments are consistent with BioCentury's September 22nd report that CDER director Janet Woodcock stated that the guidance would be issued "promptly."
It is clear that FDA has been steadily working toward a biosimilars draft guidance. After a long period of radio silence, in August the New England Journal of Medicine published an article titled "Developing the Nation's Biosimilar's Program" co-authored by FDA employees, including CDER director Janet Woodcock. We reported on that article here. Most commentators believe that FDA's upcoming guidance will hew closely to the principles set out in August's NEJM article.
In particular, FDA will likely allow itself a large amount of flexibility in determining the requirements for the approval of a biosimilar application, including the types of clinical and/or analytical studies necessary. Agency flexibility is particularly critical here because (1) biological products vary significantly in terms of complexity and difficulty in characterization and (2) analytical techniques will likely evolve over time. In addition, it would not be surprising for FDA to adopt principles from recent EMA draft guidelines. Finally, given the lack of attention paid to interchangeability in the NEJM article, it seems doubtful that FDA will focus much on such requirements in the upcoming guidance.
FDA and industry have also recently reached a "tentative" agreement on the user fee structure for biosimilar applications. Indeed, the proposed user fee structure reflects FDA's expectation that developing a biosimilar product will require more early-stage interaction with FDA. The tentative agreement appears to be similar to the original FDA proposal, which included product development and application fees for pending products as well as product and establishment fees for marketed products. Also, the tentative agreement requires at least $20 million in "non-user fee funds" (read federal funding).