Biosimilars Round Up: July 2026

July brought continued momentum across the biosimilars landscape, from congressional efforts to strengthen market competition to new analytical and clinical data supporting biosimilar development.

This monthly roundup highlights some of the month's biggest stories, including advances in biosimilar policy, proposed romosozumab and ustekinumab biosimilars, and the FDA's acceptance of Sandoz's generic tirzepatide applications.

Biosimilar Bills Advance in Congress, but Broader Reform Remains Unfinished

Congress is once again taking up legislation aimed at improving biosimilar adoption, with several bipartisan bills advancing through committees this year. The proposals target issues such as reimbursement, regulatory efficiency, and patient access, signaling that biosimilars remain a priority for lawmakers.¹

Still, many of the policy changes stakeholders have long pushed for have yet to move forward. Reforms addressing pharmacy benefit manager practices, payment incentives, and broader market barriers remain absent, leaving questions about whether the current legislation will meaningfully increase biosimilar uptake on its own.

Romosozumab Biosimilar Matches Reference Despite Structural Differences

A proposed romosozumab biosimilar demonstrated comparable functional activity to the reference product despite small differences in disulfide bond patterns, according to new analytical data.²

Researchers found the structural differences did not affect target binding or other critical quality attributes, supporting biosimilarity. The findings highlight the importance of comprehensive analytical testing and add to the growing evidence supporting biosimilar development in osteoporosis, where fewer competitors are currently in the pipeline than in oncology or immunology.

FDA Accepts Sandoz Generic Tirzepatide Applications

The FDA has accepted Sandoz's abbreviated new drug applications for generic versions of tirzepatide, marking another milestone in the race to bring lower-cost alternatives to the blockbuster diabetes and obesity therapy.³

Unlike monoclonal antibodies, tirzepatide is regulated as a peptide, making it eligible for the generic approval pathway rather than the biosimilar pathway. The applications also underscore a growing regulatory gap, as peptide-based medicines continue to blur the line between traditional generics and biologics.

Repeated Switching Data Support Biosimilar ABP 654

New data suggest patients can safely switch multiple times between ustekinumab and the investigational biosimilar ABP 654 without compromising efficacy, safety, or immunogenicity.⁴

The results add to a growing body of evidence supporting switching between reference biologics and biosimilars. As payers increasingly implement biosimilar-first policies, studies like this may help reassure clinicians who remain hesitant about repeated transitions during long-term treatment.

References

1. Jeremias S. Biosimilar bills gain steam in congress, but key reforms still wait. AJMC. July 23, 2026. Accessed July 31, 2026. https://www.centerforbiosimilars.com/view/biosimilar-bills-gain-steam-in-congress-but-key-reforms-still-wait

2. McCormick B. Romosozumab biosimilar matches reference in functional testing despite disulfide differences. AJMC. July 16, 2026. Accessed July 31, 2026. https://www.centerforbiosimilars.com/view/romosozumab-biosimilar-matches-reference-in-functional-testing-despite-disulfide-differences

3. Jeremias S. FDA accepts Sandiz generic tirzepatide applications amid biosimilar development gap. AJMC. July 13, 2026. Accessed July 31, 2026. https://www.centerforbiosimilars.com/view/fda-accepts-sandoz-generic-tirzepatide-applications-amid-biosimilar-development-gap

4. Jeremias S. Biosimilar ABP 654 maintains efficacy, safety after repeated switching from ustekinumab. AJMC. July 7, 2026. Accessed July 31, 2026. https://www.centerforbiosimilars.com/view/biosimilar-abp-654-maintains-efficacy-safety-after-repeated-switching-from-ustekinumab