Biosimilar Medicines Conference Amsterdam 2026: SPC Extension, Biotech Act and What It Means for Manufacturers

Two days in Amsterdam. The Biosimilar Medicines Conference covered many topics: CES waivers, global reliance pathways, AI at the EMA, procurement reforms. Several points were genuinely contentious.

One topic kept coming back.

The Biotech Act contains a proposal to extend supplementary patent protection (SPC) by 12 months. The proposal is framed as an industrial policy instrument. The biosimilar industry reads it differently.

Europe already has the longest SPC protection worldwide: up to 16.5 years, compared with 14 years in the United States. The proposed extension would benefit those companies that have publicly communicated that they are directing 99 percent of their future research and development investments to the United States and China. The costs fall on patients and healthcare systems. The estimated impact of a delayed market opening for just three molecules (Keytruda, Darzalex, Opdivo) amounts to 7.7 billion euros per year.

At the same time, 70 percent of the biologics losing exclusivity status by 2032 have no biosimilar candidate in development. The regulatory instruments to address this are already laid out in the Biotech Act: CES waivers, harmonized IP frameworks, procurement reforms. An SPC extension works against all three.

The political outcome will directly determine what biosimilar market entries will look like from 2027 onwards: development timelines, patent clearance, commercial viability at launch.

This is exactly the area in which we support biosimilar manufacturers: from regulatory strategy and HTA positioning through clinical development programs to a robust market entry and supply chain planning. If the next patent cycle window is on your radar, now is the right time for an initial assessment.