A Comparison of the Biosimilar Accessibility in China, the EU, and the U.S.: China’s Biosimilars Commercialized at an Impressive Speed

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.

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The number of biosimilars in the EU is calculated according to the generic name, including some products voluntarily withdrawn;Etanercept is not calculated in China.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 approved in the year;

► 2019 was the first year of the era of biosimilars in China, with 4 monoclonal antibodies approved for marketing and accelerated commercialization;

► Review and approval policy differences aside, from the perspective of monoclonal antibodies, fusion proteins, and G-CSFs, the number of approved biosimilars to global super-blockbuster drugs (monoclonal antibodies + fusion proteins) is basically equal in the EU and the U.S.

II. A comparison of monoclonal antibody, fusion protein and G-CSF biosimilars in the EU and the U.S.

I’ve sorted out the marketing and commercialization status of monoclonal antibody, fusion protein and G-CSF biosimilars in China, the EU, and the U.S. according to the public information, to compare the accessibility from perspectives of respective number approved, number commercialized, earliest approval time, and commercialization time.

A Comparison of the Accessibility of Main Biosimilars in China, the EU, and the U.S.

Formally commercialized on Dec. 31, 2019; #Whether Ogivri, Trazimera, and Kanjinti will be commercialized is still unclear; &Whether Fulphila, Udenyca, and Grasustek will be commercialized is still unclear; **The drugs are deemed commercialized when their prices are published on the internet. The biosimilar Cyltezo developed by Boehringer Ingelheim has been approved for marketing in the EU, however, the company has abandoned the EU market and chosen to focus on the U.S. market of the drug that is expected to be commercialized in the U.S. on July 1, 2023.

The commercialization status of some biosimilars is unknown. Seen from the current situation:

► In terms of the total number of monoclonal antibody, fusion protein and G-CSF biosimilars, the EU has 36, the U.S. has 25, and China has 4, with the proportion of successfully commercialized biosimilars: 70% in the EU, 44% in the U.S., and 75% in China;

► In terms of the accessibility of monoclonal antibody, fusion protein and G-CSF biosimilars, both the EU and the U.S. have at least one biosimilar commercialized, except adalimumab and etanercept;

► China is the best in terms of the accessibility of etanercept, with Yisaipu approved earlier than the original drug;

► China, despite the small number of biosimilars, is very quick with the commercialization, with the accessibility not late for long;

► The first trastuzumab biosimilar will be approved in China in 2020 and is expected to be commercialized very soon.

Finally, the accessibility of biosimilars has greatly reduced patients’ burden as seen from the recent prices available on the internet, for example, the prices of Anjianning and Ankeda are 11-16% lower than the negotiated NRDL prices of the original drugs in 2019!

Biosimilars are of great significance as they make innovation benefit more patients!

Prices of Original Drugs and Biosimilars in China

*Negotiated NRDL prices in 2019

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