Wire · regulatory
Medicines for Europe calls for Biotech Act reforms to address 'biosimilar void'
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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.
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1 source · 4 Aug 2026
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