Biosimilar News: Approvals & Deals

How to Read This Feed

This is a rolling news digest, organized by theme rather than by date, and written for people who do biosimilar deals rather than merely track them. Each item pairs a verified development with a one-line read on why it matters commercially. It is deliberately distinct from our standing market analysis — for the broad picture of where the value pools sit and how licensing deals are structured across the wider patent cliff, start with Biosimilars, the Patent Cliff and Licensing. This page is the feed; that page is the framework.

A note on scope. The US biosimilar count has crossed roughly 86 approved products by mid-2026, and a digest cannot list them all. We focus on the developments that change a dealmaker’s calculus: first-in-class approvals, the molecules with the largest reference revenue, the policy shifts that reset the rules, and the manufacturers worth knowing as counterparties. For the deep, brand-by-brand list on the most-litigated molecule, see our Humira biosimilar list.

Recent Notable Approvals

A snapshot of the approvals that mattered most across 2025 and into 2026. Dates reflect FDA approval (not launch, which is frequently gated by patent settlements and can lag by months).

The pattern is unmistakable: classes that were monopolies two years ago — denosumab, ustekinumab, aflibercept — now carry four, six, even a dozen approved competitors, and previously untouched molecules like pertuzumab and golimumab have fallen.

The Denosumab Flood

No class better illustrates 2025’s dynamic than denosumab, the Amgen bone-health franchise sold as Prolia (osteoporosis) and Xgeva (cancer-related skeletal events). Sandoz opened the market — its Wyost and Jubbonti (denosumab-bbdz) were approved in March 2024 and launched in June 2025 at a reported discount of roughly 7–14% to the reference list prices. Then the gates opened.

• Feb 2025 — Samsung Bioepis (Ospomyv/Xbryk). The second pair to win an interchangeable designation. Why it matters: interchangeability at launch lets a product chase pharmacy-level substitution from day one.
• 2025 — Celltrion, Fresenius Kabi, Henlius/Organon, Biocon. By late 2025 the FDA had approved roughly six denosumab biosimilars, with Celltrion (Stoboclo/Osenvelt), Fresenius Kabi (Conexxence/Bomyntra) and Biocon (Bosaya/Aukelso) all securing interchangeability. Why it matters: a six-runner field compresses price faster than the typical two-or-three-entrant launch.
• Dec 2025 — mAbxience and Amneal. Further approvals deepened the bench. Why it matters: each new entrant strengthens the payer’s hand at the rebate table.
• Mar 2026 — Teva (Ponlimsi). A Prolia biosimilar from a major generics player. Why it matters: denosumab is now a commodity contest, not a differentiated one.

For a licensor, the lesson is sobering. Being approved is no longer an event; being approved first, with interchangeability and a committed channel partner, is. A denosumab biosimilar arriving fifth or sixth competes almost entirely on rebate depth.

There is a deal-timing point buried in the denosumab story too. The molecules that flooded the market in 2025 were, in most cases, licensed or partnered years earlier — when denosumab still looked like a clean two-or-three-entrant opportunity. The originators that captured value were those who moved before the field was obvious; the ones now negotiating US rights into a six-runner race are accepting far thinner economics. The same dynamic is playing out one molecule ahead in oncology and immunology, which is why we treat early sourcing as the single highest-leverage activity in biosimilar dealmaking.

The Stelara Biosimilar Wave

Ustekinumab (Stelara), Johnson & Johnson’s immunology blockbuster, was the marquee class of 2025. Amgen’s Wezlana (ustekinumab-auub) — the first approved, back in 2023 — launched in January 2025 under a settlement, and a crowd followed almost immediately. By early 2025 roughly half a dozen had launched, including Selarsdi (Alvotech/Teva), Pyzchiva, Otulfi, Yesintek (Biocon) and Steqeyma, with the approved count climbing toward a dozen.

Two 2025 milestones stand out. In May, Bio-Thera and Hikma’s Starjemza (ustekinumab-hmny) and Alvotech/Teva’s Selarsdi (ustekinumab-aekn) secured interchangeable designations — a marker of how quickly the class matured from “biosimilar available” to “pharmacy-substitutable.” Why it matters: Stelara is the test case for whether a richly competitive immunology class delivers the savings that the Humira launch arguably did not, because the channel — not the molecule — controls uptake.

Eye Care and Oncology Firsts

Beyond the immunology and bone-health volume plays, 2025 delivered firsts in two higher-barrier areas.

Aflibercept (Eylea). The retinal anti-VEGF class opened with two interchangeable biosimilars — Samsung Bioepis’s Opuviz and Biocon’s Yesafili — approved in May 2024, followed by Formycon’s Ahzantive, Sandoz’s Enzeevu and Amgen’s Pavblu, and then Celltrion’s Eydenzelt as the sixth approval in October 2025. Several entrants have navigated at-risk launch and patent litigation with Regeneron. Why it matters: ophthalmology biosimilars require careful handling of the high-dose (8 mg) formulations and physician comfort, so the class rewards manufacturers who can pair supply with clinical credibility.

Pertuzumab (Perjeta). In November 2025 the FDA approved Henlius and Organon’s Poherdy (pertuzumab-dpzb) — the first-ever Perjeta biosimilar, and an interchangeable one — for HER2-positive breast cancer. Why it matters: Perjeta had been a biosimilar-free island, and the first entrant being a Chinese-originated molecule (Shanghai Henlius) commercialized by a Western partner (Organon) is the cross-border template in miniature. We unpack that originate-in-China, sell-in-the-West model in our work on biotech M&A and the patent cliff.

The Interchangeability Reset

The most consequential biosimilar news of the cycle is not any single approval — it is the FDA’s steady dismantling of the interchangeability hurdle. Since 2010, US law has carried two tiers: a “biosimilar,” and an “interchangeable biosimilar” that a pharmacist can substitute without prescriber sign-off, the latter historically requiring expensive switching studies. That structure is being taken apart in stages.

• June 2024 — draft guidance dropping switching studies. The FDA concluded that, across approved interchangeables, the risk from switching was insignificant, so dedicated switching studies are generally no longer needed. (Of the early interchangeable approvals, most had already cleared without such data.)
• Late 2025 — proposal to streamline comparative efficacy studies. The agency proposed that large comparative clinical efficacy trials are often unnecessary when analytical and pharmacokinetic data already establish biosimilarity — potentially stripping the single most expensive line item out of biosimilar development.
• The endgame — deem all biosimilars interchangeable. The FDA has signaled it would seek to amend the Public Health Service Act to remove the separate interchangeability standard entirely, treating every approved biosimilar as substitutable.

Why it matters, and to whom. For developers, lower trial cost and a faster path tilt the build-versus-license math and make more molecules economically viable — good news for the pipeline, more competition for any single asset. For licensors, the marketing advantage of an “interchangeable” label erodes, so differentiation shifts to manufacturing reliability, device/formulation, and channel relationships. This is a regulatory tailwind for volume and a headwind for pricing — precisely the combination that makes deal structure, not science, the determinant of returns.

On the Horizon: The Keytruda Cliff

Every biosimilar conversation eventually arrives at pembrolizumab. Merck’s Keytruda was the world’s best-selling single product in 2025 at roughly $31.7 billion (the GLP-1 franchises of Lilly and Novo Nordisk were larger at the molecule level), and its key US exclusivity is expected to lapse around 2028, with European protection running toward 2030–2031 via supplementary protection certificates. It would be the first checkpoint-inhibitor biosimilar opportunity — a category-defining event.

The race is already crowded. Formycon has positioned FYB206 and is reportedly the first non-Chinese developer to complete a pivotal study; Samsung Bioepis, Celltrion, Sandoz, Amgen and Henlius are all advancing programs, with several FDA submissions plausible in 2026–2027. Merck, for its part, is defending with lifecycle moves including a subcutaneous formulation. Why it matters: I/O biosimilars are analytically and clinically harder than the antibodies that came before, and the winners will be those who secured manufacturing capacity and global rights years ahead of the cliff. For a Western company without an internal program, that is an in-licensing decision to make now, not in 2028.

The strategic stakes are unusually high because of what Keytruda became. It is not a single-indication antibody but the backbone of dozens of approved oncology regimens, which means a biosimilar entrant inherits an enormous addressable market and an equally enormous expectation of supply reliability. The likely outcome is a two-tier class: a small group of well-capitalized originators able to manufacture at scale and litigate through the patent thicket, and a long tail of programs that never reach commercially meaningful volume. Picking the right partner from that field — and locking terms before the 2028 window forces everyone to the table at once — is the cross-border judgment call that will define the next decade of I/O biosimilar value.

Pricing, PBMs and Private Label

The defining lesson of the Humira biosimilar launch is that approvals do not lower costs — channels do. Despite a list price up to roughly 85% below Humira, biosimilar uptake stalled for over a year until the pharmacy benefit managers acted. When CVS Caremark removed branded Humira from major formularies in 2024 and steered volume to biosimilars, it moved more than 90% of Humira prescriptions to biosimilars within months — most of it to its own private-label product supplied through Cordavis, the subsidiary it launched in 2023.

That private-label model is now the template. Optum Rx built Nuvaila for Stelara; the major PBMs increasingly populate formularies with a high-list-price branded biosimilar, a low-list-price unbranded version, and a private-label option whose economics the PBM controls. Why it matters: for a biosimilar developer, securing a private-label partnership with a PBM-aligned distributor can matter more than being first to market or even interchangeable. The competition has moved upstream into the rebate architecture, and the policy debate over whether private labeling helps or hinders genuine price competition is live. Anyone licensing a biosimilar into the US must underwrite the channel, not just the asset.

The pricing story also intersects with federal reform. Reference pricing and most-favored-nation mechanics could reshape the spread a biosimilar competes against — we cover that in our explainer on most-favored-nation drug pricing. For biosimilar economics specifically, the interaction between MFN reference points and PBM rebates is the variable to watch.

Europe, Korea, China and the Global Bench

Read the sponsor column of any recent approval table and the same names recur — and few of them are traditional US pharma. Europe’s biosimilar market remains the most mature in the world, with substitution embedded in national health systems years ahead of the US, and its regulators continue to clear new pertuzumab and tocilizumab biosimilars. But the manufacturing center of gravity sits increasingly in Asia.

• Samsung Bioepis (Korea). A prolific originator across denosumab (Ospomyv/Xbryk), aflibercept (Opuviz) and the pembrolizumab race — typically commercialized through Western partners such as Organon and Sandoz.
• Celltrion (Korea). Increasingly self-commercializing in the US, with 2025 approvals across tocilizumab (Avtozma), aflibercept (Eydenzelt) and denosumab (Stoboclo/Osenvelt).
• Biocon (India) and Alvotech (Iceland). Major suppliers of the molecules behind branded and private-label biosimilars, frequently via Western marketing partners (Biocon’s Yesintek; Alvotech/Teva’s Selarsdi).
• Chinese originators — Bio-Thera, Henlius. The fastest-rising group. Bio-Thera’s molecules underpin the interchangeable Starjemza (Stelara) and Immgolis (Simponi); Henlius originated Poherdy, the first Perjeta biosimilar. The pattern is consistent: a Chinese or Korean firm develops the molecule, a Western company (Organon, Hikma, Accord, Teva) takes US commercialization rights.

For a cross-border advisory this is the heart of the matter. The biosimilar pipeline has quietly become a licensing and partnership market, in which the question for a Western company is rarely “should we build this?” and almost always “whose molecule should we license, and on what terms?” Reference pricing pressure in China — and the global push toward most-favored-nation benchmarks — only sharpens the incentive for Asian originators to monetize ex-home-market rights through partners who can navigate US channels.

What We’re Watching Next

The developments most likely to move the next edition of this feed:

• Pembrolizumab submissions. The first FDA filings for Keytruda biosimilars — the timing, sponsors and litigation posture will set the tone for the entire I/O class.
• Final interchangeability rules. Whether the FDA finalizes the elimination of comparative efficacy studies and pursues statutory “all biosimilars interchangeable” — the single biggest swing factor for development cost.
• Denosumab and Stelara price floors. How low net prices fall as five-plus interchangeable entrants compete, and what that implies for return expectations on future me-too programs.
• More untouched-molecule firsts. After pertuzumab and golimumab fell in 2025–2026, which previously biosimilar-free blockbusters draw their first entrant next — and which Asian originator brings it.
• Private-label consolidation. Whether the PBM private-label model faces regulatory scrutiny, and how that reshapes the value of a US commercialization partnership.

The throughline across all of it: biosimilars have shifted from a regulatory and scientific contest to a commercial and cross-border one. The molecules increasingly originate in Asia, the savings are gated by US channels, and the returns are decided at the deal table. For the strategic framework behind these headlines, read Biosimilars, the Patent Cliff and Licensing. If you are evaluating a biosimilar asset — in-licensing a molecule, out-licensing rights, or structuring a commercialization partnership — talk to our team.