Inside the Sandoz-Henlius licensing deal for biosimilars of Repatha, Benlysta, and Erbitux — and why one of the three targets has stayed biosimilar-free years after its patents expired
SHANGHAI / GLOBAL BIOPHARMA — Sandoz has agreed to pay Shanghai Henlius Biotech up to $77 million upfront — and as much as $314 million in total, once development and sales milestones are included — for ex-China rights to three biosimilar candidates: copies of Amgen’s cholesterol drug Repatha (evolocumab), GSK’s lupus therapy Benlysta (belimumab), and the colorectal cancer drug Erbitux (cetuximab), currently marketed by Bristol-Myers Squibb, Eli Lilly, and Merck KGaA across different territories. At Bionext AI Market Insights, we think the least obvious of the three targets — Erbitux — is actually the most interesting, because it’s a drug whose core patents expired years ago and still has no biosimilar on the market anywhere.
What Was Announced
Under the agreement, announced August 17, 2026, Henlius will handle development and manufacturing for all three biosimilar candidates, while Sandoz secures exclusive rights to register and commercialize them everywhere outside China. The payment structure breaks down as up to $77 million in upfront fees, up to $160 million tied to development milestones, and up to $77 million in additional commercial/sales-based milestones — a total near-term-plus-milestone package of roughly $314 million for this initial three-asset tranche, with Henlius expecting to invoice up to $100.5 million of that within 2026 alone.
The deal also includes an option — not part of the core $314 million figure — for Sandoz to license a recombinant human hyaluronidase enzyme Henlius has in development, a technology used to enable subcutaneous (rather than intravenous) delivery of biologic drugs, conceptually similar to the platform Halozyme has commercialized in the West.
This isn’t the companies’ first collaboration: it builds on an earlier oncology-focused partnership the two firms struck in 2025, and the framework leaves room to expand further — Sandoz has described the arrangement as covering up to 10 biosimilars in total, which would push the maximum deal value toward $322 million and grow Sandoz’s overall biosimilar pipeline from 39 assets to as many as 46.
Why Erbitux Is the Deal’s Most Telling Detail
Cetuximab’s global sales grew to roughly $1.7 billion in 2025, and its core patents have been expired for a long time — the kind of setup that normally triggers a wave of biosimilar competition, as we’ve covered extensively with Stelara’s now-crowded field of eight-plus competitors. Erbitux has had none. The reason, per multiple industry reports, is structural: cetuximab is a technically difficult molecule to replicate at biosimilar-grade consistency, and no manufacturer has successfully brought a copy to market despite years of open patent runway.
That makes this deal a useful data point on where biosimilar competition is actually constrained: not by legal exclusivity, which ran out long ago, but by manufacturing difficulty. If Henlius’s HLX05-N candidate — currently in Phase I clinical development in China, with the first patient dosed in July 2026 — successfully navigates that complexity, it would be the first cetuximab biosimilar to reach Western markets, a genuinely different kind of “first” than the crowded, patent-driven biosimilar launches we’ve tracked elsewhere in this series.
A Pricing Footnote Worth Flagging
Henlius’s own disclosure, citing IQVIA data, put evolocumab’s (Repatha’s) global 2025 sales at approximately $6.6 billion — notably higher than Amgen’s own reported product revenue for Repatha specifically, cited elsewhere at roughly $3 billion (up 36% year-over-year). That gap is consistent with a pattern we’ve flagged repeatedly in this series: IQVIA-sourced market-size figures typically reflect list/gross pricing, while company-reported product revenue reflects net, post-rebate sales. Whichever figure is closer to reality, the direction of travel is the same — evolocumab is a fast-growing, multi-billion-dollar franchise, which is exactly the kind of asset that makes a biosimilar licensing deal economically worth $150M+ in milestone payments even at the “technical development” (i.e., early/preclinical) stage HLX16 currently sits at.
Why This Deal Fits a Broader Pattern
China as the emerging biosimilar supply base. Henlius develops and manufactures; Sandoz — a company with an established Western regulatory, sales, and distribution footprint — commercializes everywhere except China. That division of labor (Chinese biotech originates and manufactures, Western partner commercializes ex-China) is becoming a recognizable deal template in biosimilars specifically, distinct from the more balanced co-development structures common in innovative/novel-mechanism licensing.
Sandoz’s volume strategy. Growing a biosimilar portfolio from 39 to a potential 46 assets is a scale play, not a single-product bet — consistent with how we’ve seen biosimilar economics work elsewhere in this series (Stelara’s field of competitors driving price down through sheer volume of entrants, rather than any single biosimilar winning decisively).
Asset-stage risk spread. The three initial targets sit at meaningfully different development stages — HLX05-N already in Phase I clinical trials, HLX16 in earlier technical development, and the belimumab candidate in early development — giving Sandoz a portfolio with near-term milestone triggers (cetuximab) alongside longer-dated optionality (evolocumab, belimumab), rather than betting the full $314 million on one readout.
What to Watch
For Erbitux specifically: Whether HLX05-N can clear the manufacturing complexity that’s kept this molecule biosimilar-free for years will be the clearest test yet of whether “patent-expired but biosimilar-free” drugs represent a genuine opportunity class or a graveyard of failed attempts investors haven’t fully priced in.
For originator companies: Amgen, GSK, and the Erbitux co-marketers (BMS, Lilly, Merck KGaA) now have a credible, funded biosimilar threat with a defined territorial scope (ex-China) and a named clinical-stage lead asset — a more concrete competitive signal than the earlier, more speculative years of “eventual” biosimilar risk.
For deal structure across the industry: Watch whether more Western biosimilar players adopt the same China-originates/West-commercializes template, given Henlius and Organon’s own prior 2022 biosimilar licensing agreement (covering Perjeta and Prolia/Xgeva biosimilars) suggests this isn’t Henlius’s first time running this exact playbook with a different partner.
BioNextAI Market Insights View
The headline dollar figure here is modest by big pharma M&A standards, but the deal is a clean illustration of two forces we’ve tracked throughout this series converging: biosimilar competition increasingly targeting any commercially viable off-patent biologic — not just the handful of blockbusters that dominate headlines — and China-based biotechs increasingly functioning as the manufacturing and early-development engine for that competition, with Western partners providing the regulatory and commercial infrastructure to bring it to market. Erbitux’s decade-long biosimilar-free run despite expired patents is the more interesting story here than the deal size itself — it’s a live test of whether “patent cliff” and “biosimilar entry” are actually the same event, or whether manufacturing complexity can functionally extend an originator’s runway well beyond what patent law alone would suggest.
About BioNextAI Market Insights Bionext AI Market Insights delivers data-driven intelligence on biopharma commercial strategy, market access, and competitive dynamics for investors, strategy teams, and industry stakeholders.
This analysis is based on publicly available company announcements and third-party reporting current as of publication, including coverage from Reuters, Fierce Pharma, BioSpace, PharmExec, PharmaShots, and Henlius’s Hong Kong Stock Exchange filing. It does not constitute investment advice. Deal terms described reflect disclosed upfront-plus-milestone structures and may not represent guaranteed payments.
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