Biosimilars gain traction with regulators and manufacturers

The stars could finally be aligned so that Americans have better access to alternative biotech therapies in the months to come. The FDA recently approved important new biosimilars for the market, updated further development guidelines, and reached agreement with industry on a program to advance biosimilar testing and production over the next five. years. Noteworthy is the access to the first biosimilar to treat macular degeneration, offering an important alternative for patients with severe visual impairment due to this eye disease and associated eye diseases.¹ The breakthrough follows the July FDA clearance of the first interchangeable biologic, a new treatment for diabetes that can be substituted for the widely used Lantus insulin glargine (see previous reports by Jill Wechsler here and here.)

The development of additional innovative follow-ups should benefit from a final guide from the FDA that updates recommendations for testing and documenting the similarity and interchangeability of products. The opinion addresses key issues such as demonstrating similar strengths of injectable biosimilars, pediatric evaluations, post-approval manufacturing changes, treatment of proprietary indications and the need for biosimilars to have routes of administration, dosage form and strength similar to a reference product.²

These advances will be complemented by the proposal to advance the development and approval of biosimilars under the third iteration of the Biosimilar User Fees Act (BsUFA III). The FDA recently released the agreement with the manufacturers for a revised and expanded BsUFA program, as set out in a 36-page “letter of commitment”.³ By issuing the letter on September 21, 2021, the FDA has given industry and interested parties time to prepare comments and questions on this regulatory program for a public meeting to be held on November 2, 2021 via webcast. .⁴ (Information on these developments and the process involved in securing the reauthorization of the BsUFA program for 2023-2027 before it expires in one year can be found at https://www.fda.gov/industry/biosimilar-user-fee-amendments / bsufa-iii-fiscal-years-2023-2027.)

The BsUFA III Letter of Commitment outlines a series of initiatives to facilitate testing and monitoring of biosimilar development, including issuing additional guidance as well as scientific study findings from the FDA to advance interchangeable products. The program clarifies agency review timelines for biosimilar applications and updates supplement review goals, which vary based on the need to consider new clinical data. The FDA allows additional meetings with sponsors during product development to answer specific questions and obtain timely clarification of agency requirements. And the BsUFA program sets deadlines for pre-approval inspections if necessary and for electronic data submissions comparable to those provided in the updated User Fee Program for Drugs and Biologics (PDUFA VII). . (See the outline of the BsUFA III objective letter from the Association for Accessible Medicine.⁵)

While these milestones are encouraging, the way forward for widespread use of biosimilars remains uncertain. In the United States, doctors and patients continue to show reluctance to switch brands to new alternatives, and insurers and forms remain uneven in coverage and reimbursement practices. Although the FDA has approved 31 biosimilars, only around 60% have made it to the market, as lengthy patent and exclusivity litigation is delaying the process. The July 30, 2021 FDA approval of Mylan’s diabetes drug, Semglee, as interchangeable with Sanofi’s Lantus and eligible for drugstore substitution should make the switch easier for patients, although the initial savings are modest. This approval marks an important step forward, opening the door to wider acceptance of follow-up biologics and potential cost savings for consumers.

Remarks

1. https://content.govdelivery.com/accounts/USFDA/bulletins/2f29d4f
2. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-biosimilar-development-and-bpci-act-guidance-industry
3. https://www.fda.gov/media/152279/download
4. https://public-inspection.federalregister.gov/2021-20432.pdf
5. https://accessiblemeds.org/sites/default/files/2021-09/AAM-BsUFA-III-One-Pager-9-21-2021.pdf