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Medicines for Europe calls for Biotech Act reforms to address 'biosimilar void'

Published

4 August 2026

Topic

regulatory

Sectors

Biotech

Geography

Europe

Source

Read at gabionline.net

Verified

Fusion42 · 4 August 2026 · Fusion42 review

Medicines for Europe calls for urgent reforms in the EU Biotech Act to address a critical biosimilar development gap threatening patient access, healthcare sustainability, and European biotech leadership. Key recommendations include regulatory streamlining, increased EU biotech manufacturing funding, opposition to SPC extension proposals, and skills development to counter rising global competition.

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

◆ The Wire takeaway

European biosimilar founders face a regulatory overhaul that opens direct routes to market entry and eases development costs. You must act quickly to leverage these changes or risk the market moving to Asian competitors.

Coverage

1 source · 4 Aug 2026

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Topics

Biotechbiosimilarsbiotech-actregulatory-reformmanufacturingintellectual-property