Drugmakers Debate Whether Parts of FDA’s Biosimilar Guidance are Unconstitutional

Regulatory NewsRegulatory News | 14 February 2019 |  By 

Drugmakers and trade groups have raised questions with two US Food and Drug Administration (FDA) guidance documents on biosimilars, including one explaining how FDA plans to transfer drugs previously approved under new drug applications (NDAs) to be biologic license applications (BLAs).

On this so-called “Deemed to be a License” guidance, which explains the NDA to BLA transition, all but one of the biopharma companies and industry groups took issue with the agency’s approach to exclusivity.

“PhRMA disagrees strongly with FDA’s plan to strip transition products of unexpired Hatch-Waxman exclusivity on the transition date and make them ineligible for reference product exclusivity,” the group said. “FDA’s approach 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.”

Similarly, Novartis raised concerns 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.”

And BIO, while acknowledging that “this issue impacts only a small percentage of the already small population of transition products,” the group says FDA’s move is an “unexpected usurpation of lawfully granted exclusivity rights could chill future investment decisions in precarious disease areas.”

On the side of those supporting FDA, however, the generic drug industry group AAM said it agreed with FDA’s position as 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.

“Moreover, AAM 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,” the comment says.

But AAM also “strongly opposes” FDA’s blanket “non-approval” policy for NDAs and 505(b)(2) applications that are tentatively approved or otherwise pending as of 23 March 2020.

“The policy is already having a devastating effect on current development programs for many important protein products, including insulins, thereby impairing competition from lower-cost biological medicines, increasing healthcare costs in the United States, and, most importantly, limiting patient access to affordable biological products,” AAM said.

The generics group also requests that FDA amend a separate Q&A to describe 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,” AAM said.

Eli Lilly, meanwhile, also urges 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.”

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