Groups seek clarity on interchangeability in BsUFA III
Groups seek clarity on interchangeability in BsUFA IIIIndustry groups and biosimilar manufacturers are seeking explicit guidance from the FDA on interchangeable biosimilar products. The comments were made to the agency as part of the reauthorization process for Biosimilar User Fee Act (BsUFA III) program.
The recommendations for improvements in the third iteration of FDA’s biosimilars review program were made as part of a public docket opened by FDA. The agency also recently held a public meeting to kick off the reauthorization process for BsUFA III, which will begin in FY 2023 and run through FY 2027.
“While FDA has published several guidance documents related to biosimilars, industry continues to struggle with the lack of clarity regarding the Agency’s policy on certain aspects of interchangeability as well as regulatory expectations for certain post-approval changes for biosimilar or interchangeable products,” Andrea Maresca wrote on behalf of the Biosimilars Forum.
The Biosimilars Forum noted that FDA has specifically excluded interchangeable biologics from its biosimilar guidance documents. “We appreciate that these exclusions may have been necessary at that time because the initial core interchangeability guidance had not yet been issued. However, it is now an appropriate time to fill in these gaps,” Maresca added.
Arlene Wolny, head of US regulatory affairs at Sandoz BioPharma, echoed the need for more interchangeability information from FDA to reduce development risks for industry. The company recommended that the agency develop interchangeable guidance focused on promotion and advertising, labeling, product presentation, and categories of post-approval process changes.
The Arthritis Foundation also pointed to interchangeability as an area where FDA could be doing more patient education. “Clearing up lingering points of confusion can help increase confidence in biosimilars, and in particular biosimilars that are not deemed interchangeable,” wrote Anna Hyde, a vice president at the Arthritis Foundation.
PhRMA and the Association for Accessible Medicine’s (AAM’s) Biosimilars Council also both urged FDA to provide more information about how the agency will assess interchangeable biosimilar products. “While we have not yet seen an interchangeable product licensed under BsUFA II, we will very likely see one during the five years encompassed by BsUFA III,” Cory Wohlbach, of Teva Pharmaceuticals, wrote on behalf of AAM’s Biosimilars Council. “For companies seeking interchangeability approval for their biosimilars, clear guidance to industry on remaining issues will significantly facilitate development and regulatory review, leading to increased patient access to the valuable therapies.”
Early meetings, revised timelines, and anti-competitive practices were some of the other issues raised in comments about BsUFA III.
PhRMA called on FDA to establish review timelines for safety labeling updates so that manufacturers of biosimilar and interchangeable products would have timely access to updated information related to the reference product.
Meanwhile, Biocon is asking FDA to consider moving from a fixed review timeline to an adaptive timeline, which would consider the agency’s review burden when setting the timelines. For instance, a product that does not require comparative clinical trials has a lower review burden than a product that needs a full comparative trial of safety and immunogenicity, wrote Sundar Ramanan, Biocon’s vice president of global regulatory affairs.
Biocon also suggested a shorter review timeline as an incentive for developing biosimilars in new areas. “To spur further competition for molecules with limited or no biosimilars, the agency should consider a lower review timeline for the first biosimilar application, much akin to the accelerated review process for drugs with breakthrough therapy designation under Prescription Drug User Fee Act (PDUFA),” Ramanan wrote.
Some commenters called on FDA to create more opportunities for sponsors to interact with the agency earlier in the development process. AAM’s Biosimilars Council recommended an additional meeting type that would not require initial analytical data. This meeting would help to get FDA input on clinical endpoints and study design.
The Biosimilars Forum echoed the importance of early-stage and pre-development meetings, as well as the need to create a mechanism for industry to obtain clarification from FDA about advice or comments given during FDA-sponsor meetings.
A 10-member coalition of public interest and consumer groups, and unions, also weighed in on how to revise BsUFA. The coalition focused its comments on how FDA could get biosimilar products to the market faster. Its correspondence also recommended that the agency coordinate with the Federal Trade Commission (FTC) to identify anti-competitive business practices by original biologic sponsors, such as rebate walls that keep newly approved biosimilars from gaining formulary access.
The coalition also called on FDA to hold a joint public workshop with FTC and the Centers for Medicare and Medicaid Services to increase understanding of how rebate walls contribute to biosimilars being blocked from drug formularies. “It is imperative that FDA, FTC, and CMS engage the patient and provider community in these workshops given that they are most directly impacted by the harms of the rebate wall,” the coalition wrote.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products.