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Healthcare

Regeneron vs. Amgen: Who's Actually Shielded From Medicare's Price Gun

CMS can only negotiate a drug's price if it doesn't already have biosimilar competition — and that single carve-out is quietly deciding which biotech's revenue base survives the IRA intact.

Image: Money Racket
By at Money Racket · Apr 15, 2026

The Inflation Reduction Act lets Medicare set a "maximum fair price" on a drug's Part B or Part D spend once it's been on the market long enough (7 years for small molecules, 11 for biologics) — but it can't touch a drug once a biosimilar is "approved and marketed." That one clause is a loophole big enough to drive a franchise through, and it's splitting Regeneron and Amgen onto opposite sides of the ledger.

CMS can't negotiate a price on a drug that already has a biosimilar rival — so the fastest way to escape Washington's price gun is to lose market share on your own terms first.

Who cashes in:

Regeneron REGN is the loophole's cleanest beneficiary. Eylea has been formally exempted from CMS negotiation because interchangeable aflibercept biosimilars (Yesafili, Opuviz) are already FDA-approved and reaching the market — the exact trigger that pulls a drug off the negotiation table entirely. Regeneron effectively gets to lose share to biosimilar competition on its own terms (pricing, rebates, formulary contracts) instead of having Washington set the number. Eylea HD's newer, longer-duration dosing and later-expiring formulation patents (into 2039) also give Regeneron a bridge product to shift volume toward as older Eylea erodes.

Amgen AMGN sits on the other side of the same mechanism for its legacy franchise, but that's also where the opportunity lives: Enbrel (IPAY 2026) and Otezla (IPAY 2027) already absorbed their MFP hits, meaning the negotiation shock for those specific products is now sunk, known, and priced in — not an overhang anymore. The real swing factor is Repatha (evolocumab), which crossed the 11-year biologic threshold around 2026 and is a candidate for a future CMS selection cycle; watch whether Amgen can get a biosimilar approved-and-marketed before CMS locks in a price, which would flip Repatha into Eylea's exempt category.

Who is exposed:

Amgen AMGN carries the nearer-term risk precisely because its biggest biologics (Repatha, and eventually other single-source franchises without biosimilar competitors queued up) don't have an obvious "approved and marketed" biosimilar escape hatch on the same timeline Regeneron does. Gilead GILD and Biogen BIIB both have aging single-source biologics running the same 11-year clock with less visible biosimilar cover lined up, keeping them structurally exposed to future IPAY cycles (2029-2030 and beyond).

The play: This isn't "biotech good, biotech bad" — it's a bet on biosimilar-timing arbitrage. A company whose patent cliff and biosimilar approvals land just ahead of CMS's negotiation clock effectively converts a regulatory threat into a market-share problem it already knows how to fight. Watch CMS's IPAY 2029 selection list and FDA's biosimilar approval calendar together — the gap between them is where the next winner gets picked.

Source: original report ↗

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