The EMA has once again come in behind the U.S. FDA, granting market access to 77 new products in 2023, fewer than half the 157 approvals the FDA processed in the 11 months from January through December 2023.
Biosimilars grabbed a lot of headlines in 2023, thanks to the biggest U.S. biosimilar launch to date targeting Abbvie Inc.’s mega-blockbuster Humira (adalimumab). Eight biosimilars referencing the immunology drug entered the U.S. market under licensing agreements with Abbvie. Amgen Inc.’s Amjevita led the pack with a five-month headstart in January. The others – including the first adalimumab interchangeable, Boehringer Ingelheim GmbH’s Cyltezo – launched in July.
In another step that blurs the distinction between biosimilars and interchangeables, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing a rule to give Medicare Part D plans more flexibility to substitute biosimilars for the reference biologics so Medicare beneficiaries can have timelier access to the lower-cost drugs. The rule would permit the plans to treat the biosimilar substitutions as “maintenance changes” that don’t require prior Medicare approval. Such changes would enable the substitutions to apply to all enrollees – and not just those who begin the therapy after the effective date of the change.
