2026 Global Biosimilars Market Midyear Review

This report provides a midyear assessment of the global biosimilar market, covering regulatory developments, product approvals, and dealmaking in the US and Europe during the first half of 2026.

2026 Global Biosimilars Market Midyear Review

This report provides a midyear assessment of the global biosimilar market, covering regulatory developments, product approvals, and dealmaking in the US and Europe during the first half of 2026.

Inside the Report

Executive Summary

The global biosimilars market is entering a new phase. The 2026 Global Biosimilars Market Midyear Review examines how regulatory change, an approaching wave of biologic loss of exclusivity, and intensifying competition are reshaping the strategies companies use to compete.

The midyear review tracks the latest market, regulatory, and competitive developments in the United States and Europe and examines what they mean for the next phase of biosimilar growth.

Three developments mark this new phase:

Companies are rethinking which capabilities they need to own.
Generics companies are selectively acquiring development, manufacturing, and commercial capabilities they previously accessed through licensing or partnerships. Amneal Pharmaceuticals’s proposed acquisition of Kashiv BioSciences and Sandoz’s move to bring manufacturing capacity in-house illustrate this shift, while Sun Pharma’s proposed $11.75 billion acquisition of Organon represents another route to building commercial scale.
Regulatory convergence is improving development economics.
The FDA and EMA are moving toward greater reliance on analytical characterization and pharmacokinetic data. The FDA estimates its revised comparator approach could save up to 50% of pharmacokinetic study costs, while comparative efficacy studies that may no longer be required by default can cost approximately $24 million and take one to three years.
The opportunity remains substantial, but competition is broadening.
More than $300 billion in global biologic sales are projected to lose exclusivity until 2030, yet only around one in ten relevant reference biologics currently has a biosimilar in development. H1 2026 brought six US approvals and ten European authorizations across an increasingly diverse range of product classes.

Changes in the Biosimilar Regulations in H1 2026 in the United States and Europe

This chapter explores how regulatory changes in the US and Europe are reducing the clinical work required to demonstrate biosimilarity and examines their impact on the cost of developing a biosimilar in H1 2026.

ARTICLE – 3 MIN. READ

Biosimilar Approvals and Launches in H1 2026

This chapter sets out biosimilar approvals granted in the US and marketing authorizations granted in Europe during H1 2026, including the date, molecule, reference product, and company for each entry.

ARTICLE – 4 MIN. READ

Generics Companies’ Positioning in Biosimilar Industry in H1 2026

Generics companies signed the two largest biosimilar transactions of H1 2026. This chapter explores how leaders manage their biosimilar business and how generics companies position themselves in the market.

ARTICLE – 5 MIN. READ

Biosimilar Deals: M&A and Licensing in H1 2026

This chapter examines major M&A and licensing activity in the biosimilar market, focusing on generics companies buying development and manufacturing capability rather than continuing to license assets.

ARTICLE – 6 MIN. READ

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

This chapter explores four key developments in H2 2026 and early 2027, including execution of announced acquisitions, regulatory follow-through, the transition from approval to commercial uptake, and licensing at scale.

ARTICLE – 4 MIN. READ

Alira Health’s Expertise in Biosimilar Industry

At Alira Health, we guide CDMO selection and GMP-compliant facility design for biosimilar commercialization, helping clients address regulatory, clinical, pricing, and market access challenges globally.

2 MIN. READ

Meet the Report Authors

Christian Hughes
Principal, Transaction Advisory Services

Daniel Dayas
Senior Associate, Transaction Advisory Services

Disclaimer

This material including, without limitation, the statistical information herein, is provided for informational purposes only. Nothing in this material should be viewed as tax, investment, legal, or other form of advice, and may not be relied on in making an investment or any other decision.

This material is based in part on information from third-party sources that Alira Health believes to be reliable, but which has not been independently verified by Alira Health. For this reason, Alira Health does not represent that the information is accurate or complete.
This material contains forward-looking statements based on information available at the time it was prepared and on certain assumptions as to future events made by Alira Health in good faith which future events are inherently uncertain and which assumptions may ultimately prove to have been inaccurate.
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The information in this report is updated as of the end of H1 2026 (June 30, 2026).

Author's Note and Methodologies

This report provides a mid-year assessment of the global biosimilar market, covering regulatory developments, product approvals, and dealmaking in the United States (US) and Europe during the first half of 2026 (January to June).

It is a companion to Alira Health’s annual Global Biosimilars Report and follows the same market and competitive dynamics lens, updated for developments since our Q3 2025 edition.

This report draws on company disclosures, regulatory releases from the Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP), and the European Commission, and specialist industry trackers including GlobalData, Big Molecule Watch, GaBI Online, and Pearce IP. The judgements set out here reflect Alira Health’s own estimates and interpretation of the underlying data. Alira Health cannot guarantee the accuracy of every figure presented, particularly given the pace of change during the period, and individual data points are subject to revision.

Regulatory and approvals tracking: Reviewed FDA and the EMA/CHMP guidance, decisions, and marketing authorizations relevant to biosimilars announced or effective during H1 2026.

Deal activity: Reviewed biosimilar-related licensing, partnership, and mergers and acquisitions transactions announced globally between July 2025 and June 2026, drawing on GlobalData’s Deals Advanced Data Export.

Verification notes. Selected figures required a specific judgment call, noted here:

FILKRI™ approval date. Most wire coverage cites February 17, 2026, but the FDA’s underlying Biologics License Application approval, per Big Molecule Watch’s tracker and the associated Biologics Price Competition and Innovation Act docket, and separately confirmed by GaBI Online’s approvals record, is dated January 15, 2026. We use January 15, 2026, throughout which supports FILKRI’s status as the year’s first approval.
Approvals lists. The six US and ten European Union approvals shown were checked against EMA/CHMP meeting highlights, individual European Public Assessment Report pages, and each product’s company release; one European Union item (Fubelv™, etanercept, Biosimilar Collaborations Ireland) was excluded from this edition because its exact European Commission decision date could not be confirmed beyond “May 2026” in public sources.
Key players’ market share figures. Sandoz (17.0%), Pfizer (13.9%), and Amgen (12.3%) reflect FY2024 global biosimilar revenue share, the most recent full-year dataset available. The combined figure of approximately 43% is derived from those three shares. The figures are revenue-based and are not comparable to share-price performance data.
Sandoz/Just-Evotec Biologics. Terms, signed November 4, 2025, and closed effective December 5, 2025, with roughly $350 million upfront and up to about $300 million additional, are as disclosed by Sandoz and Evotec and corroborated by third-party trackers.
Beyond-the-headlines deal count. The approximately 31 additional transactions are drawn from GlobalData’s Deals Data Export, filtered to biosimilar-tagged deals announced between July 2025 and June 2026; the underlying dataset does not capture the three headline transactions in Q4 2025/H1 2026, so the two figures should read as additive, not overlapping.

All other figures, from deal values and approval counts to portfolio and market-share figures, are sourced inline or in the tables above.