September 9, 2025
What if the biosimilar wave is just a ripple?
The biosimilar market is on the verge of a major "wave," with nearly $200 billion in biologics set to lose exclusivity by 2036. The opportunity is massive, but recent launches have stumbled, revealing that pricing pressures, regulatory uncertainty under the IRA, and PBM formulary "lock-outs" are making the business case much harder to justify.
What You'll Learn
- $200B on the horizon, but don't expect a tidal wave. We explore how pricing pressures and adoption hurdles are changing the game.
- Recent launches stumbled. We dig into what went wrong and how to avoid it.
- It's not a race, it's a strategic strike. Learn how to pick the right targets for success.
Three Hurdles To Clear
- The IRA curveball and how policy uncertainty is rewriting the rules
- Reimbursement reality check. Part B economics are a mess and difficult to navigate
- Pharmacy benefit managers (PBMs) add a new twist with formulary lock-outs
Strategic Plays for a New Reality
- Pick your battles. Focus on biologics with strong legal footing or commercial advantage for formulary positioning
- Make provider economics work. Offer solutions such as cost guarantees, buy-and-bill support, or pass-through discounts to close the gap
- Engage PBMs early or bypass them. Secure exclusive deals or explore alternative channels such as direct-to-employer plays and 340B programs