Global Biosimilars Market in 2026: Challenges, Opportunities, and Changes

The biosimilar market has matured steadily since 2018. In 2026, multiple companies now compete on each molecule in the biosimilar market. Price erosion has increased as a result, and regulatory requirements for approval have eased, making commercial launches more achievable. This executive summary of Alira Health’s 2026 Global Biosimilars Market Midyear Review provides an overview of these opportunities as well as the changes and challenges that companies with biosimilar products must address. 

Much of the new competition comes from traditional small-molecule generics companies, which entered biosimilars with limited large-molecule experience. Most originally did so by in-licensing, gaining a product to sell without building a development organization or a biologics plant. In H1 2026, some of these companies stopped licensing and bought the capability instead.

The two largest transactions in H1 2026 were the Amneal Pharmaceuticals agreement on April 22, 2026, to acquire Kashiv BioSciences for approximately $1.1 billion of total potential consideration, which converts Amneal Pharmaceuticals’ own licensing counterparty into a subsidiary, and the Sun Pharmaceutical Industries agreement on April 26, 2026, to acquire Organon in an all-cash transaction at an enterprise value of $11.75 billion. The Sun Pharmaceutical Industries transaction is an exception to the pattern of the period. It acquires commercial scale and an established portfolio, and the Organon biosimilar business itself rests on a license from Samsung Bioepis. Sun Pharmaceutical Industries expects the combined group to reach approximately the seventh-largest biosimilar position worldwide, and of the six positions ahead of it, only Sandoz belongs to a generics company. 

The movement of the generics industry into biosimilars has so far taken place in transactions rather than in revenue. Control of development capability, manufacturing capacity, and commercial reach is increasingly what separates companies able to launch a broad portfolio from those that depend on terms set by other parties.

Fresenius Kabi reached the same conclusion four years earlier when it acquired 55% of the contract development and manufacturing organization mAbxience, and Sandoz did the same in December 2025 with the purchase of the Just-Evotec Biologics manufacturing site in Toulouse, France.

We have also witnessed regulatory convergence that is lowering development barriers. The Food and Drug Administration (FDA) and the European Medicines Agency both moved toward approval led by analytical characterization and pharmacokinetic data, and both reduced the clinical work required to demonstrate biosimilarity. The FDA draft guidance from October 29, 2025, removed comparative efficacy studies as the default expectation. The FDA’s revised draft question-and-answer guidance as of March 9, 2026, allowed wider use of non-US-licensed comparators in pharmacokinetic studies, which the agency expects to halve the cost of that work, a savings of approximately $20 million per program. The Committee for Medicinal Products for Human Use adopted a matching reflection paper on March 16, 2026. Lower and more predictable development costs widen the set of molecules that can carry a business case and favor developers with pipeline breadth over developers dependent on a single lead asset.

Price and margin erosion in established classes with several competing products, among them adalimumab, bevacizumab, and trastuzumab, has not deterred new entrants from targeting biologics approaching loss of exclusivity. Biologics generating more than $300 billion in global sales are expected to lose exclusivity through 2030, a figure cited by Amneal Pharmaceuticals when announcing its acquisition of Kashiv BioSciences. The FDA approved 87 biosimilars in total by the end of June 2026, and approximately one in ten of the reference biologics losing exclusivity this decade currently has a biosimilar in development, so a large proportion of reference biologics losing exclusivity this decade do not currently have a biosimilar in development.

Biosimilar competition is also expanding across a broader range of product classes. H1 2026 brought the first golimumab biosimilars in the US, Immgolis™ and Immgolis Intri™, a new interchangeable insulin glargine, LANGLARA™, a new interchangeable ranibizumab biosimilar, Ranluspec™, and additional denosumab, filgrastim, and pegfilgrastim entrants. Competition now extends well beyond the first-wave oncology and immunology molecules, and in these newer classes the commercial risk is shifting from approval timing to formulary access, contracting, and supply.

In H2 2026, strategy and corporate development teams should ask two questions:

• Considering development capability, manufacturing capacity, and commercial reach, which does the company use often enough to justify owning, and which should it continue to buy from others?
• What portfolio volume justifies replacing a royalty and a manufacturing margin with the fixed cost of owning development and manufacturing, given that ownership only pays at a throughput no single asset can deliver?

To learn more, access the 2026 Global Biosimilars Market Midyear Review, which provides a mid-year assessment of the global biosimilar market, covering regulatory developments, product approvals, and dealmaking in the US and Europe during the first half of 2026.