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Trastuzumab biosimilars receive EMA and ANVISA approval Posted 26/01/2018

Trastuzumab products from Celltrion Healthcare (Celltrion) and Biocon/Mylan have received approval in Europe and Brazil.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 December 2017 that it had recommended granting marketing authorization for the trastuzumab biosimilar Herzuma.

The trastuzumab biosimilar, Herzuma, is produced by South Korean biotechnology company Celltrion. The company submitted the application for its trastuzumab biosimilar (CT‑P6) to EMA back in November 2016 [1]. Celltrion has also submitted biosimilar applications to Japan’s Ministry of Health, Labour and Welfare (MHLW) in April 2017 [2] and to the US Food and Drug Administration (FDA) in July 2017 [3].

The product is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had worldwide sales of CHF 6.8 billion in 2016. The patents on Herceptin will expire in the US in June 2019 and expired in Europe in July 2014 [4].

On 29 December 2017 Biocon and Mylan’s trastuzumab follow-on biological was approved by the Brazilian regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA), through their Brazilian partner Libbs Farmaceutica (Libbs).

Co-developed by Biocon and Mylan, this is the first trastuzumab follow-on biological to be approved in Brazil. Libbs will commercialize the product in Brazil under the brand name Zedora.

Biocon/Mylan had their trastuzumab biosimilar (Ogivri) approved by FDA in December 2017 [5]. They also resubmitted their application for approval to EMA in December 2017 [6].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Celltrion submits trastuzumab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-trastuzumab-biosimilar-application-to-EMA
2. GaBI Online - Generics and Biosimilars Initiative. Celltrion making progress with biosimilars in China and Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-making-progress-with-biosimilars-in-China-and-Japan
3. GaBI Online - Generics and Biosimilars Initiative. Two trastuzumab biosimilars submitted to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/News/Two-trastuzumab-biosimilars-submitted-to-FDA
4. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Ogivri [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Ogivri
6. GaBI Online - Generics and Biosimilars Initiative. EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-applications-for-pegfilgrastim-and-trastuzumab-biosimilars-from-Biocon-Mylan

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Source: Celltrion, EMA, Mylan

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