China’s National Medical Products Administration (NMPA) approved more novel oncology drugs than the US Food and Drug Administration (FDA) between 2020 and 2025, a shift accompanied by the expansion of China-developed biosimilars into European and North American markets, according to a study in Health Affairs Scholar, and investigation by Friends of Cancer Research.
The analysis found the NMPA approved 94 novel cancer drugs over the six-year period, compared with 87 by the FDA. The shift was driven by the latter half of the period: between 2020 and 2022, the FDA approved 1.8 times more cancer drugs than the NMPA, but in the final three years the NMPA approved 1.7 times more than the FDA.
The US retains clear advantages in genuine innovation. Of 167 drugs approved by both countries during the study period, 36 were first-in-class therapies; the FDA approved 30 of these first, 13 of which the NMPA subsequently approved as well. As of the end of the study period, the FDA had not approved any of the six first-in-class drugs approved by the NMPA first. Overall, the FDA reviewed cancer drug applications faster than the NMPA. Among applications using expedited pathways, FDA review was a median of 119 days faster than non-expedited FDA review, while the NMPA's expedited pathway reduced review time by a median of 149 days.
The approval shift comes alongside—though the study does not establish a causal link—the expansion of China-developed biosimilars into European and North American markets.
Henlius has led this biosimilar push. Its trastuzumab biosimilar Zercepac received European Commission (EC) approval in July 2020, the first China-developed monoclonal antibody biosimilar approved in Europe. The company's denosumab biosimilars Bildyos and Bilprevda, referencing Prolia and Xgeva, respectively, both cleared by the EC in September 2025. In the US, the FDA approved Hercessi (trastuzumab-strf) in April 2024 and Poherdy (pertuzumab-dpzb) in November 2025 as the first interchangeable biosimilar to Roche’s Perjeta [1]. Henlius also secured Canadian approval for Adheroza (trastuzumab) in 2026.
Qilu Pharmaceutical has similarly extended its European footprint, with Rimmyrah (ranibizumab) authorised in the EU in January 2024 and Nylaspeg (pegfilgrastim) receiving a positive CHMP opinion in June 2026 [2].
The study authors suggested that structural factors—including faster clinical trial initiation and enrolment, and lower costs in China—may influence where sponsors prioritise early development, while noting that the FDA retains substantial advantages in review speed and first-in-class innovation. For Europe, the parallel trend is the steady arrival of Chinese-developed biosimilars, with Henlius now holding EU approvals across trastuzumab and denosumab, and Qilu adding ranibizumab and, pending EC decision, pegfilgrastim.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves Poherdy (first interchangeable pertuzumab) and Armlupeg (pegfilgrastim) biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Oct 22]. Available from: www.gabionline.net/biosimilars/news/fda-approves-poherdy-first-interchangeable-pertuzumab-and-armlupeg-pegfilgrastim-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for biosimilar Denosumab Ascend and pegfilgrastim Nylas [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Oct 22]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-biosimilar-denosumab-ascend-and-pegfilgrastim-nylaspeg
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