Drug makers and trade groups have recently raised questions regarding a United States Food and Drug Administration (FDA) guidance document on biosimilars.
“Deemed to be a License” Guidance
The first guidance, the “Deemed to be a License” guidance, which explains the transition from new drug applications (NDAs) to biologic license applications (BLAs), has seen opposition from all but one of the biopharma companies and industry groups. i
PhRMA raised concerns that the FDA’s approach and “plan to strip transition products of unexpired Hatch-Waxman exclusivity on the transition date and make them ineligible for reference product exclusivity” raises “serious issues under the Takings Clause of the Fifth Amendment of the US Constitution with respect [to] NDA holders’ property rights in their trade secrets and in statutory exclusivity.”
Novartis also raised concerns, opining that rescinding unexpired regulatory data protection as part of the transition would “unjustly deprive sponsors of their confidential trade secrets and other proprietary information and property rights, raising serious constitutional concerns and undermining confidence in the laws and rights pursuant to which innovators make their R&D investment decisions.”
Eli Lilly urged the FDA to clarify the parameters for “branded biosimilars,” including “explicitly confirming that the Agency will permit such a submission under section 351(k). FDA should clarify what the biosimilarity data requirements would be for such a product and whether a switching study would be necessary to support an interchangeability determination.”
The only group that seems to agree with the FDA is the generic industry group The Association for Accessible Medicines (AAM), which believes that after the transition date, any unexpired period of exclusivity or listed patent associated with an approved NDA would no longer be relevant to a “deemed” BLA or to a 351(k) application seeking to rely upon the deemed BLA as a reference product. AAM also “agrees that a ‘deemed’ BLA is not entitled to the 4- or 12-year exclusivity periods available to biological products that are ‘first licensed’ under section 351(a) of the PHS Act because such products are not ‘first licensed’ under the PHS Act.”
Q&A Guidance
AAM also requested that the FDA contemplate amending a Q&A document that describes when 351(k) applicants can use foreign comparators without the need for clinical bridging studies. “Enabling this approach would reduce the development cost for sponsors of biosimilars and interchangeable products, in turn leading to increased patient access to more affordable alternatives to costly reference biologics,” the group said. The group then went on to detail its own proposal in the comment, including outlining how a foreign product can qualify as a “foreign comparator,” the way the comparator product should be approved according to ICH standards, and how the comparator product shall be identified.