Rachel Behrman, Director of the US Food and Drug Administration’s (FDA) Office of Critical Path Programs, outlined the challenges that follow-on biologics pose for regulators and companies at the Federal Trade Commission’s (FTC) meeting.
These included the inability at this time to ascertain that the active pharmaceutical ingredient (API) in the follow-on biologic is identical to its brand-name equivalent. In addition Behrman predicted that concerns about immunogenicity will have to be addressed in all applications.
Regulatory considerations raised by Behrman suggested that the follow-on biologics pathway may mirror the existing processes for generics and similars in many respects.
The FDA would want to know if the biogeneric is sufficiently similar to the licensed product to allow the agency to rely on existing scientific knowledge. There is also the issue of whether the FDA has legal access to this information.
Behrman said that the use of existing knowledge is fundamental to the FDA’s pathways, referring to a research paper she co-authored that was published in Nature Drug Discovery in 2007.
The paper states that: “The agency has a longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources…and avoiding ethical concerns associated with unnecessary duplication of…human testing.”
Another facet of any follow-on biologics regulations will be the need for data that confirms the biogeneric and the brand-name product could be used interchangeably.
Behrman described this as “very tricky” to ensure for biologics as they have a much higher potential to create an immunogenic response, which can diminish efficacy and safety.
All these factors highlight the complexity in the regulatory processes of biologics, which Behrman said would increase the time taken for the FDA to review an application.
In addition she implied that the difficulty in manufacturing and completing the regulatory processes for biogenerics may impact on the number of companies that are equipped to produce them.
The full roundtable can be viewed here.
GPhA welcomes roundtable
The Generic Pharmaceutical Association (GPhA) released a statement following the roundtable praising the FTC for holding the discussion.
In the release the GPhA reiterates its view that Hatch-Waxman is a reliable model to use for adopting biogenerics. Hatch-Waxman was made law in 1984 to allow for generics to be approved by submitting bioequivalence studies.
The GPhA believes that this model works for originator companies, generic manufacturers and consumers. It states: “As our elected officials grapple with issues like market exclusivity and patent resolution measures, they must do so recognising that competition will unleash innovation, while at the same time assuring that affordable lifesaving medicines are available for patients in need.”