Celltrion seeks approval for bevacizumab biosimilar in Europe, US and Korea

Biosimilars/News | Posted 03/12/2021 post-comment0 Post your comment

South Korean biotechnology company Celltrion announced in October 2021 that it had applied for marketing approval for its candidate bevacizumab biosimilar (CT P16) in Europe, Korea and the US.

Bevacizumab protein structure V16K25

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor alpha (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

Celltrion announced on 1 October 2021 that it had submitted applications for approval of CT P16 with the Korean Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration and the US Food and Drug Administration (FDA).

Then the company announced on 10 October 2021 that it had completed the application procedure for CT P16 with the European Medicines Agency (EMA). The application was submitted, according to Celltrion, ‘after completing global clinical trials for a total of 689 patients at 164 sites in 21 countries since 2018’. The company plans to obtain approval for all indications covered by the originator product, Roche’s Avastin (bevacizumab), including metastatic colorectal cancer and non-small cell lung cancer.

Celltrion also said that it is planning to apply for permits in other major countries, such as Japan.

The patents on Avastin already expired in Korea and the US and will expire in Europe in January 2022 [1]. In view of this, Celltrion has said that it plans to introduce CT P16 to the market from the second half of 2022, once it gains global approval.

There are already nine bevacizumab biosimilars approved in Europe [2], two in the US [3] and two in Korea [4]. However, Celltrion has said that, despite being a latecomer to the bevacizumab market, the company intends to compete on price.

If approved, CT P16 will be Celltrion’s third biosimilar, following Truxima (trastuzumab) and Herzuma (trastuzumab). The company is also working on biosimilars of aflibercept (CT P42), denosumab (CT P41), omalizumab (CT P39) and ustekinumab (CT P43) and plans to have one biosimilar approval every year by 2030.

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 3]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-South-Korea

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