Biosimilars

Biosimilar updates 2025

As of September 2025, the FDA has approved over 50 biosimilars across 15 reference biologics, with adoption driven by payer strategies. Adalimumab biosimilars gained momentum in 2024 as PBMs reshaped formularies—a trend now extending to ustekinumab. The 2025 approval of Omlyclo, the first interchangeable omalizumab biosimilar, marks expansion into respiratory and allergy markets.

Key trends shaping adoption include:

• Consolidation of volume around private-label biosimilars tied to payer–PBM affiliates
• Coverage strategies leveraging $0-copay programs and preferred placement
• Ongoing Medicare price negotiations influencing reference product pricing and contracting

Since 2015, biosimilars have delivered more than $30 billion in cumulative savings, and the 2025 pipeline suggests continued growth in both competition and affordability.¹

Biosimilar utilization: variability in adoption curves

The IQVIA biosimilar uptake chart shows significant variability in market adoption. Adalimumab biosimilar use was modest early on but surged after month 14 as payer formularies and contracting strategies shifted, doubling by month 20. This trend underscores how coverage and pricing, rather than clinical differences, drive uptake. Newer biosimilars like tocilizumab are just beginning to enter the market, signaling continued variability ahead.

Ustekinumab biosimilar landscape: Payer strategies will shape early adoption

Multiple ustekinumab biosimilars are set to launch in 2025, each matching the full FDA-approved label of Stelara. Early adoption will hinge on payer formulary decisions, pricing, and contracting strategies, especially ahead of Medicare price negotiations in 2026.

Private-label biosimilars from Cordavis, Quallent and Nuvaila are expected to drive uptake through lower list prices and preferred formulary placement. Amgen’s Wezlana, launched via Nuvaila with $0-copay options, highlights payer efforts to accelerate adoption.

Interchangeability designations and payer–PBM alignment will shape market share, with affiliated labels likely gaining early traction. This model is expanding across biologics, as seen with the first interchangeable omalizumab biosimilar, Omlyclo, approved in 2025.

Implications for health systems

Health systems should prepare for a payer-driven biosimilar market by anticipating:

• Coverage strategies that favor affiliated private-label biosimilars, often paired with simplified access features such as $0-copay programs.
• Formulary alignment and patient transitions strategies remain necessary as payers adopt unique product preferences.
• Growing interchangeability designations across biosimilar portfolios driving frequent formulary adjustments.

While clinical differences remain minimal, operational factors such as site of care, presentation formats and reimbursement processes will be important. Maintaining at least one formulary alternative is recommended to accommodate payer variability and patient access needs.