What to Watch in the Biosimilar Market in H2 2026 and Beyond

Regulatory change, new approvals, and shifts in company strategy shaped the biosimilars market in the first half of 2026. Regulatory changes lowered development costs, while approvals from the Food and Drug Administration (FDA) and the European Commission broadened the range of approved biosimilars. At the same time, a new wave of generics companies moved to acquire development, manufacturing, or commercial capabilities they had previously accessed through licensing.

Building on these shifts, this chapter of Alira Health’s 2026 Global Biosimilars Market Midyear Review examines four key developments expected to shape the market in the second half of 2026 and early 2027:

1. Execution of announced acquisitions. Amneal Pharmaceuticals expects to close the Kashiv BioSciences acquisition in H2 2026, subject to shareholder and regulatory approval, and Sun Pharmaceutical Industries expects to close the Organon acquisition in early 2027, subject to Organon shareholder approval and regulatory clearances. Both transactions remain proposals until those conditions are met. Integration of these businesses will show whether ownership of development and manufacturing capability delivers the launch speed and cost position that the acquirers have paid for, and the outcome could determine whether the next tier of generics companies internalizes capability or continues to license it.
   
   
2. Regulatory follow-through. The FDA comparator-pharmacokinetics guidance of March 9, 2026, remains in draft as of September 2026. Finalization could give sponsors certainty on the use of non-United States (US) comparators and could confirm the possibility of the pharmacokinetic similarity study savings of up to approximately $20 million per program (learn more in the report chapter “Changes in the Biosimilar Regulations in H1 2026 in the United States and European Union”). The question for H2 2026 is whether developers, particularly smaller and non-US companies, begin redesigning active programs to use the lower-cost pathway, because the savings are only available to programs that have not yet completed their clinical package.
   
   
3. Commercial uptake for approved products. H1 2026 approvals opened new molecule classes and added competition to established classes, and the two groups could behave differently. The first US golimumab biosimilars could show how quickly price erosion and share shift occur in a newly opened class, and Ennumo™, the eighth US pegfilgrastim biosimilar, could show what differentiation remains available in a class where price is already compressed. Formulary access, contracting, supply reliability, and litigation outcomes could determine the pace in both cases.
   
   
4. Licensing at scale. Not every H2 2026 signal will come from the acquisitions above. Alvotech’s rest-of-world patent settlement converts into a real test over the next year, with launches staggered across the European Economic Area from May 1, 2026, and Japan from November 1, 2026, through regional partners ADVANZ PHARMA, STADA, Biogaran, and Fuji Pharma. Whether those launches convert into share at the pace the settlement implies could provide a direct read on how much a cleared patent position is worth on its own. Separately, the Samsung Bioepis agreement with Sandoz, covering up to five future biosimilar candidates led by SB36, is a licensing commitment to pipeline rather than an approved product, and its value might not be visible until those candidates clear development, a longer horizon than the other three developments above. Together, the two agreements are the licensing-side counterparts to the acquisition-focused watch items, and will provide evidence on how licensing at this scale compares with ownership-based models.
   • Deal Upate as of October 2, 2026: Samsung Bioepis has since signed a comparable agreement with Teva Pharmaceuticals for up to six candidates, led by SB41 and SB44, showing that this portfolio-level licensing model extends beyond a single developer-generics partnership.

Additional longer-term watch item: pembrolizumab. Pembrolizumab warrants monitoring now because developers and the originator are already taking steps that could shape future biosimilar competition. For generics companies, upcoming filings, partnerships, manufacturing commitments, and patent developments will provide early evidence of whether they are building the capabilities needed to compete in this major market.

KEYTRUDA^® generated $29.5 billion in sales in 2024, and at least seven developers are positioning candidates. Formycon has reported Phase I results for FYB206, Amgen is developing a pembrolizumab candidate alongside its ABP 206 and ABP 692 programs, and Merck & Co. is developing the subcutaneous formulation KEYTRUDA QLEX™, so biosimilar positioning and originator lifecycle defense are both already under way. Given the size of the molecule and that only one of the current top six biosimilar companies by revenue is a generics company, the positions taken over the next 18 months could shape not just the pembrolizumab ranking but whether generics companies close that gap by the start of the 2030s.

In H1 2026, generics companies have taken five routes to position themselves in biosimilar space: 

1. Full internalization (e.g., Fresenius Kabi)
2. Manufacturing-only ownership (e.g., Sandoz)
3. Development-only ownership (e.g., Amneal Pharmaceuticals)
4. Commercial-scale route (e.g., Sun Pharmaceutical Industries)
5. Product-only route (e.g., Accord BioPharma)

The first three routes show acquisitions used to convert a specific recurring cost into an owned asset; the choice among them depends on which single cost (development, manufacturing, or both) a company’s own portfolio volume justifies removing. Routes four and five show that acquisition also works without focusing on capability acquisition; companies may buy revenue or an established commercial position instead and leave the capability decision for later.

The developments of H1 2026 highlight the importance of choosing which biosimilar capabilities to own and which to access through licensing or partnerships. The acquisitions discussed in the chapter “Biosimilar Deals: M&A and Licensing in H1 2026” illustrate different priorities, from securing development and manufacturing capabilities to expanding commercial reach. Their value will depend on whether the acquired businesses deliver benefits that justify the investment and integration required.

For strategy, business development, and investment teams, this means assessing ownership at the portfolio level. In Alira Health’s assessment, acquiring a development platform or manufacturing capacity may be justified when it supports multiple products at sufficient scale. Licensing can remain a more efficient way to access individual assets or enter specific geographies. Its continued importance is reflected in the transaction mix: licensing accounts for 26 of the approximately 31 additional transactions tracked in the period.

These choices also have implications for dedicated biosimilar developers and contract development and manufacturing organizations (CDMOs). Developers need to consider how licensing agreements support near-term funding and commercialization while preserving longer-term strategic options, including a potential acquisition. For CDMOs, customers’ moves to bring selected capabilities in-house reinforce the importance of differentiated expertise and a diversified customer base.

The next phase will test how these approaches perform in practice. Acquisition completion and subsequent integration, launches through licensing partners, and uptake of newly approved products will provide evidence of where ownership creates an advantage and where partnerships remain effective. Success will depend on how well each model supports a company’s portfolio, resources, and commercial ambitions.