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Wire · regulatory

EU Lawmakers Back Unlimited Biosimilar Stockpiling Under SPC Waiver

14 September 2026 · By · Wire by Fusion42

Published

14 September 2026

Topic

regulatory

◆ Sectors

Biotech

◆ Geography

Europe

◆ Source

Read at insights.citeline.com →

◆ Verified

Fusion42 · 14 September 2026 · Fusion42 review

EU lawmakers have supported allowing unlimited stockpiling of biosimilars under the Supplementary Protection Certificate (SPC) waiver, potentially easing market entry and supply chain flexibility for biosimilar manufacturers in Europe.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

EU biosimilar founders gain a rare regulatory opening allowing unlimited stockpiling, removing a key barrier to supply reliability and market readiness.

◆ Coverage

1 source · 14 Sep 2026

◆ Related on Wire

◆ Topics

Biotechbiosimilarsspc-waivereu-regulationpharmamarket-access