The Food and Drug Administration (FDA) has scheduled a May 11, 2012, public hearing in Silver Spring, Maryland, “to obtain input on recently issued draft guidances relating to the development of biosimilar products.” Information about and links to the draft guidances appear in Issue 29 of this Bulletin. FDA is also soliciting input on topics for future biosimilars-related policies.
Those wishing to present during the public hearing must register by April 11, and FDA will accept written comments until May 1. A live Webcast can be viewed at http://www.fda.gov/Drugs/NewsEvents/ucm265628.htm on the day of the hearing, and a recording will be available at the same site for one year.
According to its Federal Register notice, FDA is requesting comments “from a broad group of stakeholders, such as health care professionals, health care institutions, manufacturers of biomedical products, interested industry and professional associations, patients and patient associations, third party payers, current and prospective BLA [biologics license application] and new drug application (NDA) holders, and the public.” Specifically, FDA seeks feedback on whether (i) particular issues in the guidance documents have been addressed satisfactorily, (ii) the agency should have addressed other issues, (iii) FDA’s thinking “is sufficiently clear to provide meaningful guidance to stakeholders,” and (iv) the usefulness and clarity of the documents can be enhanced. See Federal Register, March 2, 2012.
Meanwhile, a Nature Biotechnology editorial contends that FDA’s pathway to approval for biosimilars may make it difficult for all but brand manufacturers to demonstrate that a biosimilar product is clinically similar to the reference product. According to the editorial, FDA went further than what is already required in the European Union and appears to be calling for identity with the reference product rather than with defining similarity. It also states that biologics originators “will find in the guidances a pleasingly detailed and potentially arduous path for any biosimilar manufacturer hoping to cut into a market share of their brand products. Such US brand companies may also see the clarifications about FDA’s biosimilar pathway as a basis for going out and buying companies that already have a foothold in the European biosimilars space, whether European, Indian, Chinese, Korean or otherwise. Because the FDA is placing so much emphasis on analytical characterization and proof of similarity, brand manufacturers will be in a strong position to use their internal confidential business information about biomanufacturing processes in biosimilar subsidiaries to create new revenue streams.” See Nature Biotechnology, March 2012.