How Will Biosimilars Fare in the FDA Post Gottlieb and Christl?

News that FDA Commissioner Scott Gottlieb, MD, will step down from his position in 1 month’s time took stakeholders by surprise on Tuesday and raises questions about how the agency will approach biosimilars when it comes under new leadership.

Throughout his tenure at the FDA, Gottlieb has been vocal about the importance of creating a sustainable biosimilars market in United States. In addition to releasing the Biosimilar Action Plan, he called on drug makers to “end the shenanigans,” including the misuse of Risk Evaluation and Mitigation Strategy programs. He has also taken aim at lengthy patent litigation practices in the United States, pay for delay tactics, and rebates and contracting provisions between pharmacy benefit managers and manufacturers, all of which he said were making the biosimilars market unstable in the United States.

Gottlieb’s approach to biosimilars was seen by many as a sea change; James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, told The Center for Biosimilars^® in an interview that Gottlieb represented “a quantum leap in terms of activism.” Shehan said that Gottlieb’s tenure at the FDA compared with those of previous commissioners has been “a pretty stark contrast” in terms of “what he’s done and been willing to do to make the drug market more competitive.”

Biosimilar developers were in harmony with that assessment; the Biosimilars Council, a division of the Association for Accessible Medicines, told The Center for Biosimilars^® in an email that a “testament to his commitment to bringing more affordable generic and biosimilar medicines to patients are the record number of approvals seen during his tenure. But [Gottlieb] understood that approvals were not enough to spur competition, and his leadership extended to improving market conditions to ensure these generic and biosimilar medicines would not be blocked.”

The Biosimilars Forum, also in an email to The Center for Biosimilars^®, said that “Commissioner Gottlieb has shown strong leadership in both his words and actions to increase access to biosimilars and bring real savings to the US healthcare system…As Congress debates solutions to rising health care costs, it’s been voices like Commissioner Gottlieb’s that are needed to properly highlight the safety, effectiveness and lower costs of these treatments and combat the rampant misinformation that is hurting the US biosimilars market.”

While Gottlieb’s departure has garnered the most attention, it is not the only recent FDA shake-up that could have an impact on the agency’s approach to biosimilars.

Leah Christl, PhD, previously the associate director for therapeutic biologics, director of the therapeutic biologics and biosimilars staff in the office of new drugs in the FDA’s Center for Drug Evaluation and Research, left the FDA in February 2019. Christl, who was replaced at FDA by Sarah Yim, MD, moved to Amgen, reported Regulatory Focus, where she will serve as the drug maker’s executive director of global regulatory and research and development policy beginning on March 11.

During her time at the FDA, Christl was key in facilitating such efforts as developing the agency’s approach to interpreting the Biologics Price Competition and Innovation Act, as well as negotiating and implementing the Biosimilar User Fee Acts.

Christl also frequently served as the face of the agency in communicating about biosimilars; from her “Ask Me Anything” session on biosimilars at the website Reddit to her frequent appearances at biosimilars meetings, Christl was vocal about the need for stakeholder education on biosimilars and the need for the FDA to play an active role in that educational effort.

“It’s not just enough to say, ‘trust us, we got this,’” said Christl in a 2018 presentation on biosimilars. “It’s really important to explain what we’re doing, how we’re doing it, and what we’re looking for in our scientific standards. That then gives people the information to understand the underpinnings of the approval of those products and have confidence that they will be safe and effective products.”

Departure of both Gottlieb and Christl from the agency in short succession raises questions about how ongoing initiatives related to biosimilars will be carried forward under new leadership.

Key projects taken up during Gottlieb and Christl’s tenure include long-awaited and highly anticipated final guidance on interchangeability. Christl had previously indicated that the FDA would issue either revised draft or final guidance no more than 2 years after the end of the comment period on the draft guidance, or May 2019.

Stakeholders are also currently awaiting an agency response to a 2018 citizen petition, filed by Pfizer, asking the FDA to issue guidance on how drug companies may communicate about biosimilars in order to address misinformation about these products.

Other ongoing efforts related to biosimilars include the enhancement of the Purple Book, assessment of the feasibility of using non—US-licensed comparator products in biosimilar development, and coordination with the Federal Trade Commission to address unfair delays to market competition, among others.