Global Biosimilars Market Enters a New Phase as Competition and Regulatory Change Reshape the Market

The global biosimilars market is entering a new phase. Alira Health’s 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 US 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.