A collection of associations for higher education wrote to FDA Commissioner Margaret Hamburg urging a requirement for biosimilar applicants to certify that they have complied with the information exchange and patent dispute resolution provisions of the BPCIA. The concern raised is that:
“biosmilar sponsors can effectively circumvent every patent litigation provision of the statute simply by failing to provide timely requirement for notice and access to the reference product sponsor without meaningful consequences, despite the requirement for such notification.”
As stakeholders in the patent dispute resolution process, the higher education associations urge the Food and Drug Administration that:
“A mandatory yet simple requirement that biosimilar applicants certify their compliance with the notice and access provisions of the statute is warranted.”
This is another instance where manufacturers and trade associations believe FDA must play a role in refereeing potential disputes between pioneer companies and biosimilar applicants. Other close watchers, including the Biotechnology Industry Organization (BIO) and Pharmaceutical Manufacturers of America (PhRMA), have made similar comments in responses to the FDA draft guidances on biosimilars released earlier this year.
The November 5, 2012 letter was signed by:
- The American Council on Education (ACE)
- The Association of American Medical Colleges (AAMC)
- The Association of American Universities (AAU)
- The Association of Public and Land-grant Universities (APLU)
- The Association of University Technology Managers (AUTM) and
- The Council on Governmental Relations (COGR).