What changed
The global biosimilar market has reached a 20-year milestone. The first regulatory approval cited was Europe’s 2006 approval of somatropin, a recombinant human growth hormone.
The market is now being framed around three competitive priorities: lower costs, more differentiated product portfolios and partnerships that extend across borders.
Why it matters
Twenty years after the first approval, biosimilars are no longer defined simply by entering a market after an original biologic. The harder question is how manufacturers compete once products become increasingly genericized.
Cost efficiency may determine who can stay competitive. Differentiated portfolios could help companies avoid relying on a single product. Global partnerships may offer another route to reach patients and markets, though no specific agreement or winner has been identified.
The immediate shift is strategic rather than regulatory: global biopharma companies, biosimilar manufacturers and European regulators are now part of a market shaped by maturity. Which approach works best remains unsettled.
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