Tussle over BPCIA “Market” Versus “Data” Exclusivity Continues; This Time the Generic Supporters Chime In

January 21, 2011

By Kurt R. Karst –     

Following the submission of two letters to FDA from both members of the U.S. House of Representatives and the U.S. Senate (see our previous posts here and here) critical of the Agency’s recent characterization of the 12-year reference product exclusivity period provided by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) as “marketing exclusivity” rather than “data exclusivity,” several generic drug manufacturers (Hospira, Momenta Pharmaceuticals, Hospira, Mylan Labs, Teva Pharmaceuticals, and Watson Pharmaceuticals) and other companies and organizations (AARP, Aetna, CVS Caremark, Express Scripts, GPhA, Humana, Medco, and the Pharmaceutical Care Management Association) have added their voice to the debate. 

Under the BPCIA (PHS Act § 351(k)(7)(A)-(B)), FDA cannot approve a biosimilar or interchangeable product that references a brand biologic product until 12 years after the first licensure of the reference (brand) product; however, a biosimilar or interchangeable applicant can submit an application to FDA 4 years after the date on which the reference product was first licensed.  This is somewhat similar to the FDC Act, which provides a 5-year period of new chemical entity exclusivity during which time an ANDA or a 505(b)(2) application containing the protected active moiety cannot be submitted to FDA, except that the application can be submitted beginning at year 4 of the exclusivity period if the ANDA or 505(b)(2) application contains a Paragraph IV certification to an Orange Book-listed patent to the reference listed drug containing the protexted moiety.

In a January 20, 2011 letter to FDA Commissioner Dr. Margaret Hamburg, the generic supporters say that PHS Act § 351(k)(7)(A)-(B) creates periods of both data and market exclusivity:

[D]uring the initial four years of the 12-year period, effectively a reference brand product has both data exclusivity for its application and market exclusivity in relation to biosimilar applicants under the Section 351(k) pathway.  After the initial four years, the data exclusivity expires (meaning that a biosimilar application that benefits from a reference brand biologic showing of safety and efficacy can be filed), and the market exclusivity continues for the remaining eight years. Congress wisely recognized the confusion that the terms “data” and “market” exclusivity caused during the legislative debate and chose to define clearly the process to avoid confusion.

Furthermore, the generic supporters allege that any interpretation of the BPCIA’s reference product exclusivity provisions to prevent the submission of biosimilar or interchangeable product applications for 12 years could have serious consequences.  “If the legislation is interpreted to prevent biosimilar filings for 12 years, consumers will have to endure an unknown period of delay of FDA review and approval that could stretch far beyond the 12-year total that was set in the legislation,” says the letter.  “We concur with the FDA’s initial understanding of the provision and ask that FDA implement the law as passed.”