Managed Healthcare Executive December 12, 2025
Key Takeaways
- Regulatory changes have expedited biosimilar development, eliminating switching studies for interchangeability, reducing costs and timelines for manufacturers.
- Significant 2025 FDA approvals include Poherdy for HER2-positive breast cancer, Omlyclo for allergic conditions, and Merilog and Kirsty for diabetes management.
- Sandoz’s Tyruko, a biosimilar for Tysabri, treats multiple sclerosis and Crohn’s disease, with a focus on safety due to PML risk.
- Denosumab biosimilars, referencing Prolia and Xgeva, launched with competitive pricing, offering substantial cost savings and increased patient access.
The biosimilar market experienced 16 new approvals by early December 2025, marking significant expansion and introducing previously unavailable biosimilar drug classes to patients.
The biosimilar market is beginning to see the impact of a regulatory change made last year....
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