Woodcock Bemoans Lack Of 'Biobetter' Provision In BPCIA
Executive Summary
CDER director lobbied for inclusion of a 505(b)(2)-like category for biologics, but it was ultimately not included in the 2010 legislation creating the biosimilar pathway; Woodcock urges patience on the development of the biosimilar marketplace and notes the agency will be keeping an eye on the development of biobetters, which are relatively new innovations.
While striking an overall optimistic tone on the future of the US biosimilars market, Center for Drug Evaluation and Research (CDER) director Janet Woodcock bemoaned the absence of a "biobetter" pathway from the Biologics Price Competition and Innovation Act (BPCIA).
Speaking on 23 September at the Drug Information Association's Biosimilars Conference, Woodcock said that despite her lobbying efforts for the inclusion of a biobetter provision in the legislation, the enacted law does not contain a pathway analogous to the 505(b)(2) pathway for small molecule drugs.
Biobetters are informally known as biological products that are designed to be improved versions of existing biologics. They could, for example, feature a different route of administration from the approved product or consist of a new dosage form.
But without a 505(b)(2)-like pathway for biologics, biobetters must be developed as novel biologics.
Woodcock said that the US Food and Drug Administration will have to keep an eye on what she referred to as an emerging trend of companies developing biobetters, specifically biologics designed for use with medical devices. Manufacturers have taken to developing autoinjectors and other delivery devices as alternatives to the burdensome intravenous infusion process typically associated with biologics, she noted.
"This will add another twist to the whole biosimilar area and we are keeping our eye on that. … And so these drug delivery systems and new dosage forms, basically and so forth, we are going to have to take a look at," Woodcock said.
Any action, however, will be "some time off" in the future, she added, since most biobetters are more recent innovations. (See sidebar for a story on how the issue may play out for insulin.)
Striking An Optimistic Tone
Woodcock nevertheless was extremely optimistic about the future of the biosimilars market in the US. She noted that there are 83 biosimilars for 38 reference products enrolled in the FDA's biosimilar development program.
"That's really quite spectacular," Woodcock said.
She also alluded to recent media coverage that raised concerns about the slow growth of the biosimilars market in the US. Notably, Peter Bach, director of Memorial Sloan Kettering's Center for Health Policy and Outcomes, and Mark Trusheim, a visiting scientist at the MIT Sloan School of Management, recently authored an op-ed in The Wall Street Journal arguing that it is time for the US to "throw in the towel" on biosimilars. (Also see "Gottlieb Calls On Congress To Act On US Biosimilars Uptake" - Generics Bulletin, 27 Aug, 2019.)
The CDER director argued that it was unrealistic to expect that biosimilars would boom overnight in the US. The market was similarly slow take off in the European Union, she said. (Also see "Biosimilars In EU: From 'New Mess' To Beacon For Safety" - Pink Sheet, 26 Jun, 2017.)
"It takes a great deal of time to get your act together to produce a new biological product," Woodcock said. "And if you have to produce that to certain specifications to match an innovator, that's even more difficult. And if you have to do scientific work to reverse engineer the innovator when you don't have really good access to the API, the drug substance, then you even have another challenge. And so it was predictable that a long time would happen."
Throughout the nearly 10 years for which the BPCIA has been enacted, the FDA has approved 23 biosimilars, nine of which have launched.
"I think it's been remarkable with what alacrity the industry has gotten itself together, has done the reverse engineering, has done the development programs, has produced biosimilar products and gotten them through the US regulatory process," Woodcock continued.
And although patent disputes have continued to prevent many of the approved biosimilars from launching, Woodcock contended that they are "growing pains" of the law which "I think it will sort itself out over time."
"I think some patience and some optimism is really warranted," she said.
Woodcock's comments echo those of former FDA Commissioner Scott Gottlieb, who in several instances said that it wasn't realistic to expect biosimilars to take off so quickly in the US. (Also see "Gottlieb Shifts From Regulatory To Reimbursement Focus In One Of First Post-Commissioner Appearances" - Pink Sheet, 12 May, 2019.)
Gottlieb has been a frequent cheerleader for biosimilars both during his time as a commissioner and as a private citizen. In 2018, the agency unveiled its Biosimilars Action Plan to help accelerate competition in the field. (Also see "Avoiding ‘Groundhog Day’: US FDA’s Biosimilar Action Plan Applies Lessons From Generic Competition" - Pink Sheet, 23 Jul, 2018.)
[Editor’s note: Join Pink Sheet executive editor Nielsen Hobbs and Catalyst Healthcare Consulting president Nancy Myers for a webinar to discuss the past and the future of the commissioner position on 22 October at 11am EDT. Registration is free and open now.]
Generics, Biosimilars Will Have Similar Development Paradigms
Woodcock also contended that the biosimilar development paradigm is eventually going to resemble the generic drug development paradigm.
She credited modern technology with helping the scientific community to learn more about originator biological products than was known when they were first approved.
"As we develop confidence, as we learn more about immunogenicity, as we develop analytical methods that are more fingerprint-like and so forth, we are going to be able to have more confidence and less residual uncertainty after all the analytical comparisons are done," Woodcock said. "We are going to have more confidence in the performance in the biosimilar, because we know not just more about the biosimilar, we know more about the innovator than we did when we approved it.
"And so that's one of the goals, that as we gain scientific knowledge, we can make these programs as streamlined as possible," the CDER director continued. "And from what I have seen, that's definitely, definitely going to be possible."