MEPs seek to boost biosimilars in pharma protection deal
EU Legal Affairs Committee support compromise offering drugmakers longer protection in return for European investment, while clearing the way for faster biosimilar competition
The European Parliament’s Legal Affairs (JURI) Committee has agreed a compromise that would link an extension of Supplementary Protection Certificate (SPC) protection to investment in Europe, while enabling biosimilar manufacturers to compete from day one after expiry.
The agreement, reached as part of JURI’s work on the Biotech Act, would allow originator companies to obtain an additional 12 months of SPC protection, but only if they meet conditions designed to support European clinical research and manufacturing.
MEP Tiemo Wölken (S&D, Germany) told Vital Signs that the compromise was “a balanced deal that benefits both innovative industry and biosimilar manufacturers.”
“Originators can gain an additional 12 months of SPC protection, linked to conducting multi-country clinical trials in the Union and maintaining a significant share of production here,” Wölken said. “This allows us to support innovation while also working towards our goal of strengthening Europe’s strategic autonomy.”
Wölken also pushed back against calls for longer or unconditional SPC extensions. “What does the Union gain from handing out additional years of market exclusivity if there is nothing in return?” he asked.
“If we grant additional monopoly protection, we should also secure a clear benefit for Europe, our production capacity, our clinical research and ultimately for our strategic autonomy.”
Crucially for Europe’s biosimilar industry, JURI is proposing to extend the SPC manufacturing waiver to biosimilars allowing unlimited stockpiling before protection expires.
“Biosimilar manufacturers will benefit from unlimited stockpiling possibilities, allowing them to prepare for market entry on day one after patent expiry,” Wölken said.
He stressed the economic distinction between the two sides of the compromise: “The SPC extension will place a significant burden on member states’ health systems, whereas stockpiling comes at no additional cost.”
The approach reflects a broader push to make EU pharmaceutical policy deliver tangible benefits for European production. Wölken linked the deal to the Critical Medicines Act and its emphasis on considering European manufacturing in procurement decisions.
“We need to use these instruments together to strengthen European production, resilience and strategic autonomy,” he said.