THE RISE OF CHINA - ARE CHINESE MEDICINAL PRODUCTS SUCCESSFULLY LAUNCHING IN EUROPE?
Author(s)
Paula Skowron, MPharm1, Karolina Banas, MPharm1, Anirban Hore, MPharm2, Alice Chiu, MSc3, Peter Wagner, BMS4, Anke van Engen, MSc5.
1IQVIA, Warsaw, Poland, 2IQVIA, Bangalore, India, 3IQVIA, London, United Kingdom, 4IQVIA, Frankfurt, Germany, 5IQVIA, Amsterdam, Netherlands.
1IQVIA, Warsaw, Poland, 2IQVIA, Bangalore, India, 3IQVIA, London, United Kingdom, 4IQVIA, Frankfurt, Germany, 5IQVIA, Amsterdam, Netherlands.
OBJECTIVES: Chinese biopharmaceutical companies are increasingly expanding globally, with more innovative therapies entering Europe. This research examined European regulatory approvals and health technology assessment (HTA) outcomes for medicinal products from Chinese marketing authorization holders (MAH) compared with rest-of-the-world (RoW) MAHs.
METHODS: Medicinal products from Chinese MAHs approved by the European Medicines Agency (EMA) in 2021-2025 were identified and reviewed using European regulatory and HTA reports identified via the Market Access Insights (MAI) platform. Biosimilars and generics were excluded. HTA outcomes were classified as positive, positive with conditions/restrictions, or negative, and compared with RoW MAH products approved in the same therapeutic area and time period. Pivotal trial population and decision drivers were analyzed.
RESULTS: In 2021-2025, five Chinese MAH products received EMA approval across 18 indications, all in oncology. Approvals increased from 1-2 annually in 2021-2023, to 9 in 2024, and 4 in 2025. Among pivotal trials, 48% included mixed population (26% predominantly Caucasian, 22% predominantly Asian), 43% Asian-only, and 9% Caucasian-only. Among 102 HTA reports for Chinese MAH products published between January 2021 and May 2026, 87 had a formal HTA outcome. Negative outcomes were more frequent for Chinese than RoW MAH products (22% vs 18%), while positive outcomes were less frequent (20% vs 25%). Fewer positive HTA outcomes for Chinese MAH products were observed in Germany, France, and Poland. Asian or predominantly Asian trial populations were criticized in 48% of HTAs but impacted HTA outcome in only 13%. The most common drivers of negative HTA outcomes for Chinese MAH products were inappropriate comparator (37%), lack of cost-effectiveness (32%) and not generalizable trial population (21%).
CONCLUSIONS: Chinese MAHs are launching more products in Europe but face HTA challenges, with fewer positive HTA outcomes compared to products from RoW MAHs. Alignment with European evidence expectations will be critical to avoid HTA disadvantage.
METHODS: Medicinal products from Chinese MAHs approved by the European Medicines Agency (EMA) in 2021-2025 were identified and reviewed using European regulatory and HTA reports identified via the Market Access Insights (MAI) platform. Biosimilars and generics were excluded. HTA outcomes were classified as positive, positive with conditions/restrictions, or negative, and compared with RoW MAH products approved in the same therapeutic area and time period. Pivotal trial population and decision drivers were analyzed.
RESULTS: In 2021-2025, five Chinese MAH products received EMA approval across 18 indications, all in oncology. Approvals increased from 1-2 annually in 2021-2023, to 9 in 2024, and 4 in 2025. Among pivotal trials, 48% included mixed population (26% predominantly Caucasian, 22% predominantly Asian), 43% Asian-only, and 9% Caucasian-only. Among 102 HTA reports for Chinese MAH products published between January 2021 and May 2026, 87 had a formal HTA outcome. Negative outcomes were more frequent for Chinese than RoW MAH products (22% vs 18%), while positive outcomes were less frequent (20% vs 25%). Fewer positive HTA outcomes for Chinese MAH products were observed in Germany, France, and Poland. Asian or predominantly Asian trial populations were criticized in 48% of HTAs but impacted HTA outcome in only 13%. The most common drivers of negative HTA outcomes for Chinese MAH products were inappropriate comparator (37%), lack of cost-effectiveness (32%) and not generalizable trial population (21%).
CONCLUSIONS: Chinese MAHs are launching more products in Europe but face HTA challenges, with fewer positive HTA outcomes compared to products from RoW MAHs. Alignment with European evidence expectations will be critical to avoid HTA disadvantage.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA316
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas