Woodcock cites 'vigorous interest' in biosimilar development

Regulatory NewsRegulatory News | 28 May 2021 |  By 

Janet Woodcock, the acting commissioner of the US Food and Drug Administration (FDA), says there has been a “significant increase” in biosimilars approvals as the pharmaceutical industry has shown renewed interest in developing these drugs.
The agency has also met some of the “key deliverables” of its 2018 Biosimilars Action Plan to develop a more competitive market for these products, said Woodcock, who gave the keynote address at the annual meeting of the Association of Affordable Medicines on 26 May. At the meeting, she cited some of the latest industry actions and approvals during the public health emergency of the COVID-19 pandemic and described efforts to spur drug development through the Generic Drug User Fee Amendments of 2012 and the Biosimilars User Fee Amendments of 2017 (BsUFA II). 
Referring to biosimilars, Woodcock told attendees, “I am pleased to say that interest in this sector continues to be vigorous.” She said that FDA approved 29 biosimilars, 20 of which are currently marketed, up from 12 approved and four marketed biosimilars when the Biosimilars Action Plan was released in July 2018.
In another sign of interest, Woodcock said that as of 1 May, 94 programs are participating in the biosimilar product development program. This figure is up from the 63 programs participating in October 2018, the 73 in October 2019 and the 84 in the program by September 2020. (RELATED: FDA’s Biosimilar workload: 57 development programs, $81 M spent in first three fiscal years, Regulatory Focus, 14 March 2016)
The agency also received a healthy number of meeting requests to discuss the development of biosimilars for 43 different reference products. Woodcock said that “the future looks even brighter as this industry becomes more mature.”
Despite initial high hopes, the launch of the biosimilars market has been sluggish in the US. A recent Health Affairs blog post points to insurance formulary problems, along with prescriber knowledge gaps and patent issues, as explanations for slower uptake of biosimilars in the US as compared with Europe.  (RELATED: Insurance, physician barriers impede wider adoption of biosimilars, Regulatory Focus, 12 April 2021)
To further encourage the industry’s growth, Woodcock said the agency is developing a biosimilar education curriculum for medical, nursing and pharmacy schools and plans to expand the availability of biosimilar-related continuing education for health care providers to increase the depth of familiarity for health care workers.
Woodcock touted the agency’s success in meeting some key milestones of its Biologics Action Plan. One such deliverable was the release of the Purple Book, which she called a “dynamic, easy-to-use online search engine with timely information about all licensed biological products.”
In August 2020, FDA updated the Purple Book database to include all FDA-licensed biological products and to provide exclusivity information on these products. (RELATED: FDA Purple Book database now includes all CBER-, CDER-licensed biological products, Regulatory Focus, 3 August 2020)
Woodcock said that progress “continues to be made” on the outstanding deliverables.
Woodcock said that the agency is also continuing to work with industry to strengthen biosimilar product development through the BsUFA III negotiations now underway. She said that negotiations are focused on four key areas intended to strengthen the program: maximizing scientific and regulatory clarity, facilitating communication, ensuring predictability and promoting efficiency in biosimilar and interchangeable product development.
COVID-19 challenged everything
 Woodcock also addressed how the pandemic affected the agency’s workload. She said that “COVID-19 challenged everything we do: assessment, inspections, research, surveillance and policy. Both new and long-standing issues were raised, including supply chain, changing demand and decision-making based on evolving science and risk.”
She said that during the public health emergency, the agency “prioritized” the assessment of generic drug submissions involving potential COVID treatments and approved more than 900 original and supplemental abbreviated new drug applications (ANDAs) for these drugs.
Even during the pandemic, she said that the agency approved or tentatively approved “hundreds of ANDAs,” including many first generics.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you