BioMed Innovations Blog

The Food and Drug Administration (FDA) plans to hold a public hearing on May 11, 2012, from 8:30 a.m. to 5 p.m., to gather feedback on its recently released draft biosimilars guidance documents.  The FDA’s release of the draft guidance documents is a significant milestone toward the implementation of the Biologics Price Competition and Innovation Act of 2009, which establishes an abbreviated path for the approval of biologic products that are biosimilar to, or interchangeable with, a reference product.  The FDA plans to finalize these draft guidance documents based on the information it receives during the hearing.

Individuals wishing to comment on the FDA’s draft biosimilars guidance may present at the hearing if they register by April 11, 2012, and may submit written comments until May 1, 2012.

The hearing will take place at the FDA’s White Oak Campus, which is located at 10903 New Hampshire Avenue, Building 31, Room 1503, in Silver Spring, Maryland.  The FDA is broadcasting a live webcast of the hearing for those who are unable to attend.  In addition, transcripts will become available no sooner than 30 days after the hearing.

Please review the FDA’s notice, or contact David A. Fazzolare for more information.

The FDA recently announced a notice of public meeting and request for comments in the Federal Register regarding proposed recommendations for a user fee program for biosimilar biological products for fiscal years 2013 through 2017. The Federal Register notice describes the FDA’s proposed user fee program, as well as FDA’s proposed performance goals and procedures.

The public meeting will be held on Friday, December 16, 2011, from 9 a.m. to 1 p.m at FDA’s White Oak Campus in Silver Spring, MD. Registration to attend the meeting must be received by December 14, 2011. The FDA requests that electronic or written comments be submitted by January 6, 2012. Further details on how to register or submit comments can be found here.

The proposed recommendations include four types of fees, including biosimilar product development (BPD) fees, marketing application fees, and establishment and product fees, which are summarized briefly below.

The FDA proposed biosimilar product development fees include an initial BPD fee for each product and an annual BPD fee.  Sponsors are required to pay only a single initial BPD fee for each product no matter how many indications are proposed for the product. The initial BPD fee for each fiscal year from 2013 to 2017 is proposed to be 10 percent of the human drug application fee established under PDUFA for that fiscal year.  Each year thereafter an annual BPD fee is due on or before October 1 until a marketing application that is submitted by the sponsor is accepted for filing or the sponsor stops participating in the BPD program.

The FDA proposed that the marketing application fee be equivalent to the human drug application fee established under the Prescription Drug User Fee Act (PDUFA), less any cumulative BPD fees already paid for the biologic product. The FDA also proposed that the product establishment and product fees be equivalent to the establishment and product fees established under PDUFA for any given fiscal year.

For more information, check out the FDA’s notice published in the Federal Register or contact David Fazzolare.

The Biologics Price Competition and Innovation Act of 2009 (the “Biosimilars Act”) was enacted in 2010 as a component of the Patient Protection and Affordable Care Act. The Biosimilars Act grants biosimilar manufacturers an abbreviated market approval pathway comparable to the abbreviated approval pathway for generic drugs under the Hatch-Waxman Act.

Joanna Brougher and I recently coauthored an article about the Biosimilars Act entitled “Will the Biosimilars Act Encourage Manufacturers to Bring Biosimilars to Market?” The article was published in the Food and Drug Law Institute’s (FDLI’s) Policy Forum and is available for download here. A brief summary of the article follows.

Like the Hatch-Waxman Act as originally enacted, the Biosimilars Act raises concerns that must be dealt with before achieving the right balance between promoting innovation and increasing access to affordable biologic medicines. These concerns include: (1) inadequate incentives to encourage development of biosimilars; (2) uncertain exclusivity timelines for biosimilars that may weaken biosimilar market exclusivity; and (3) ambiguities that allow brand and generic biologics manufacturers to extend their market exclusivity and delay authentic biosimilar competition.

We proposed the following solutions to address these concerns: (1) award market exclusivity to first-to-market biosimilar products and strengthen market exclusivity for first approved interchangeable biosimilars: (2) clarify the uncertain generic exclusivity timelines that diminish the value of interchangeable biosimilar market exclusivity; and (3) amend the Biosimilars Act to remove ambiguities that encourage agreements between brand and generic biologic manufacturers that delay authentic biosimilar competition.

By implementing these solutions, the Biosimilars Act may better encourage development of biosimilar products without reducing existing incentives for innovative biologic development.

I recently wrote an article looking at whether the Biosimilars Act encourages the development of generic biologics, or biosimilars, or whether it instead has the opposite effect of discouraging development of generics. The Biosimilars Act, also known as the Biologics Price Competition and Innovation Act, was signed into law on March 23, 2010 by President Obama as part of the healthcare reform provisions included in the Patient Protection and Affordable Care Act. The Biosimilars Act is designed to provide manufactures of generic biologics an abbreviated approval pathway similar to the approval pathway for generic drugs under the Hatch-Waxman Act.

While the Biosimilars Act seems to strike a balance between innovation and fostering access to medicines, the Act, as written, contains certain provisions that may instead prevent or, at least, discourage development and commercialization of generic biologics. These provisions include, for instance, the uncertain generic exclusivity timelines that may either weaken generic market exclusivity or that may provide loopholes for collusive agreements between innovator and generic manufacturers that may harm generic competition. These uncertain provisions may end up discouraging manufacturers from developing generic biologics, leaving consumers with increasingly fewer generic options.