Biosimilar Exclusivity / Trade Secret Concerns Raised from FDA's Biosimilar Draft Biosimilar Guidances
On February 9, 2012, FDA released draft guidances on biosimilars on scientific considerations, quality considerations, and general questions related to the new 351(k) approval pathway for biosimilars. One of the exclusivity provisions found in the 351(k) pathway provides for 12 years of innovator exclusivity. The duration of the innovator exclusivity was a contentious topic and debated fiercely during the development of biosimilar legislation. The 12-year term was viewed by the branded industry as a major victory.
Now, FDA's proposed approach to awarding 12 years of exclusivity for novel biologics and its protection of reference product trade secrets during the course of examining a biosimilar application has ignited new concerns. Innovators are upset over the language in the draft guidances that proposes that biological license application ("BLA") sponsors should request 12 years of innovator marketing protection. Furthermore, innovator drug companies are dubious of the protection afforded by FDA in shielding innovators' trade secret information during FDA's communications with biosimilar sponsors during the evaluation process.
The draft guidance states that an applicant:
[M]ay include in its BLA submission a request for reference product exclusivity under section 361(k)(7) of the [Public Health Service] Act, and FDA will consider the applicant's assertions regarding the eligibility of its proposed product for exclusivity. At this time, FDA suggests that an applicant's request for reference product exclusivity specifically describe how the proposed product meets the statutory requirements in section 351(k)(7) of the PHS Act, and include adequate data and information to support the request.