THE BIOSECURE EFFECT: EU MARKET ACCESS IMPLICATIONS FOR CHINA-ORIGINATED PD-(L)1 INHIBITORS
Author(s)
Alistair Blair, MSc1, Anwen Tay, BSc1, Richard Macaulay, BA, PhD2.
1Precision AQ, London, United Kingdom, 2Precision AQ, Edinburgh, United Kingdom.
1Precision AQ, London, United Kingdom, 2Precision AQ, Edinburgh, United Kingdom.
OBJECTIVES: To characterise the emerging EU HTA landscape for China-originated PD-(L)1 inhibitors and identify patterns in outcomes, pricing, and commercialisation as US legislative and regulatory barriers increasingly redirect Chinese innovators toward Europe.
METHODS: All China-originated PD-(L)1 inhibitors with EMA marketing authorisation as of 20 May 2026 were identified. Completed HTA assessments were extracted from NICE (England), G-BA (Germany), and HAS (France) for each indication. German list prices were benchmarked against six established PD-(L)1 comparators. Manufacturer-level patterns in pricing, indication targeting, and commercial strategy were analysed.
RESULTS: Four agents received EMA approval across 18 indication-drug pairs: tislelizumab (9 indications), serplulimab (5), toripalimab (2), and sugemalimab (2); two lack FDA approval. HTA progress varies considerably across markets, with the greatest activity in Germany. In England, no completed assessment exists for any product. In France, four assessments are complete, only one with a published reimbursement price. In Germany, 10 assessments have concluded, of which nine were for tislelizumab; eight resulted in no added benefit ratings (two in orphan-designated indications). Distinct manufacturer-level pricing strategies are emerging. Tislelizumab adopted discount positioning in Germany (€4,123/month vs €5,589 for pembrolizumab, a 26% discount). Toripalimab set a free price at a premium (€6,951/month), targeting two indications with limited PD-(L)1 competition. Serplulimab entered at parity with established competitors (€4,951/month). Sugemalimab has no completed assessment or price in any market.
CONCLUSIONS: The US Biosecure Act, combined with FDA scrutiny of China-centric clinical data, signals an increasingly hostile environment for Chinese pharmaceutical innovation in the US, accelerating a strategic pivot toward Europe. The absence of US market access frees these manufacturers from Most Favored Nation reference price constraints, enabling aggressive discount strategies. Established PD-(L)1 manufacturers, whose pricing flexibility is constrained by the need to protect US reference prices, may be unable to respond in kind, with significant implications for EU competitive dynamics.
METHODS: All China-originated PD-(L)1 inhibitors with EMA marketing authorisation as of 20 May 2026 were identified. Completed HTA assessments were extracted from NICE (England), G-BA (Germany), and HAS (France) for each indication. German list prices were benchmarked against six established PD-(L)1 comparators. Manufacturer-level patterns in pricing, indication targeting, and commercial strategy were analysed.
RESULTS: Four agents received EMA approval across 18 indication-drug pairs: tislelizumab (9 indications), serplulimab (5), toripalimab (2), and sugemalimab (2); two lack FDA approval. HTA progress varies considerably across markets, with the greatest activity in Germany. In England, no completed assessment exists for any product. In France, four assessments are complete, only one with a published reimbursement price. In Germany, 10 assessments have concluded, of which nine were for tislelizumab; eight resulted in no added benefit ratings (two in orphan-designated indications). Distinct manufacturer-level pricing strategies are emerging. Tislelizumab adopted discount positioning in Germany (€4,123/month vs €5,589 for pembrolizumab, a 26% discount). Toripalimab set a free price at a premium (€6,951/month), targeting two indications with limited PD-(L)1 competition. Serplulimab entered at parity with established competitors (€4,951/month). Sugemalimab has no completed assessment or price in any market.
CONCLUSIONS: The US Biosecure Act, combined with FDA scrutiny of China-centric clinical data, signals an increasingly hostile environment for Chinese pharmaceutical innovation in the US, accelerating a strategic pivot toward Europe. The absence of US market access frees these manufacturers from Most Favored Nation reference price constraints, enabling aggressive discount strategies. Established PD-(L)1 manufacturers, whose pricing flexibility is constrained by the need to protect US reference prices, may be unable to respond in kind, with significant implications for EU competitive dynamics.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA13
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
Oncology