Biosimilars Gain Traction with Regulators and Manufacturers

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Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

The stars finally may be aligned for Americans to gain greater access to alternative biotech therapies in the coming months. FDA recently approved important new biosimilars for market, updated guidance on follow-on development, and reached agreement with industry on an agenda for advancing biosimilar testing and production over the next five years. Of note will be access to the first biosimilar to treat macular degeneration, providing an important alternative for patients experiencing serious vision impairment from this and related eye diseases. That advance follows FDA authorization in July of the first interchangeable biologic, a new treatment for diabetes that can be substituted for widely used Lantus insulin glargine.

The development of additional innovative follow-ons should gain from an FDA final guidance that updates recommendations for testing and documenting product similarity and interchangeability. The advisory addresses key issues such as demonstrating similar strengths of injectable biosimilars, pediatric assessments, postapproval manufacturing changes, dealing with indications covered by exclusivity, and the need for biosimilars to have similar routes of administration, dosage form, and strength to a reference product.

These advances will be augmented by the proposal for advancing biosimilar development and approval under the third iteration of the Biosimilar User Fee Act (BsUFA III). FDA recently released the agreement with manufacturers for a revised and expanded BsUFA program as spelled out in a 36-page “Commitment letter”. In posting the letter Sept. 21, 2021, FDA provided industry and interested parties with time to prepare comments and questions on this regulatory program for a public meeting to be held on Nov. 2, 2021 via webcast. Information on these developments and on the process involved in ensuring reauthorization of the BsUFA program for 2023-2027 before it expires in a year can be found at

The BsUFA III commitment letter describes a range of initiatives to facilitate the testing and oversight of biosimilar development, notably by issuing additional guidance plus findings from FDA scientific studies to advance interchangeable products. The program clarifies timelines for agency review of biosimilar applications and updates review goals for supplements, which vary based on the need to consider new clinical data. FDA authorizes additional meetings with sponsors during product development to address specific questions and gain timely clarification of agency requirements. And the BsUFA program sets timeframes for pre-approval inspections where needed and for electronic data submissions comparable to those provided in the updated user fee program for drugs and biologics (PDUFA VII) [see outline of BsUFA III goals letter from the Association for Accessible Medicine .


While these milestones are encouraging, the road ahead to widespread use of biosimilars remains uncertain. Physicians and patients in the United States continue to show reluctance in switching from brands to new alternatives, and insurers and formularies remain uneven in coverage and reimbursement practices. Although FDA has approved 31 biosimilars, only about 60% have come to market, as lengthy patent and exclusivity disputes delay the process. FDA’s July 30, 2021 approval of Mylan’s diabetes drug Semglee as interchangeable to Sanofi’s Lantus and eligible for substitution at the pharmacy should make it easier for patients to switch, even if initial savings are modest. That approval marks an important advance, opening the door to more widespread acceptance of follow-on biologics and potential cost savings for consumers.

About the author

Jill Wechsler is BioPharm International's Washington editor.