Biosimilars are special because they can significantly reduce patients’ burden and boost the life science innovation to benefit more people!
The EU is the forerunner in the era of biosimilars, compared to China and the U.S.! The EMA has approved the first biosimilar, i.e., Omnitrope (somatropin), early on Apr. 11, 2006. The EMA has so far approved 53 biosimilars (including 19 monoclonal antibodies, 16 G-CSFs, 5 EPOs, and 2 fusion proteins (etanercept)) and rejected the marketing applications of 2 biosimilars.
The approval of filgrastim Zarxio (filgrastim–sndz) in the U.S. on Mar. 6, 2015 unveiled the era of biosimilars in the U.S. FDA has so far approved the marketing of 27 biosimilars, including 18 monoclonal antibodies, 2 fusion proteins (etanercept), 5 G-CSFs, and 1 EPO.
Hanlikang, the first drug applied for according to the biosimilar standards in China, was approved and successfully commercialized on Feb. 22, 2019, marking the official opening of the biosimilar era in China. 4 biosimilars have been approved in China, all of which are monoclonal antibodies.
Biosimilar Approved in China, The EU and The U.S.
单抗 融合蛋白 胰岛素 生长激素 其他 | Monoclonal antibody Fusion protein Insulin Growth hormone Others |
Source: EMA & FDA & NMPA;
The number of biosimilars in the EU is calculated according to the generic name, including some products voluntarily withdrawn;Etanercept is not calculated in China.
Multiple super-blockbuster drugs have become off-patent in the world. This article gives a simple comparison of the accessibility of biosimilars in different countries and regions based on the differences of China, the EU, and the U.S. in biosimilar review and approval and only involves monoclonal antibodies, G-CSFs, and etanercept in view of the biosimilar review policy differences of China, the EU, and the U.S.
I. The EU is the forerunner in terms of biosimilars
The EU is 10 years earlier than FDA and nearly 15 years earlier than China in terms of the biosimilar review and approval, being a forerunner!
The biosimilar: growth hormone Omnitrope (somatropin) was approved early on Apr. 11, 2006. From the perspective of the number of biosimilars approved for marketing over the years in China, the EU, and the U.S
Number of Biosimilars Approved over the Years by the NMPA & EMA & FDA
Source: The EMA & FDA & NMPA;
The number of biosimilars in the EU is calculated according to the generic name, including some products voluntarily withdrawn; Etanercept is not calculated in China.
► FDA’s biosimilar era was nearly 10 years and the NMPA’s biosimilar era was nearly 15 years later than the EMA’s biosimilar era, as seen from the approval of the first biosimilar;
► 2018 became the turning point of the biosimilar review and approval in the EU, with the number reaching a peak and 14 biosimilars approved for marketing;
► FDA steadily increased the biosimilar review and approval from 2015, which reached a peak in 2019, with 10 biosimilars...
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