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Trastuzumab biosimilar Ogivri approved in Canada Posted 07/06/2019

India-based biologicals specialist Biocon and US-based partner Mylan announced on 22 May 2019 that Health Canada had approved Mylan’s trastuzumab biosimilar Ogivri.

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.

Ogivri is a biosimilar of Roche’s Herceptin (trastuzumab). It was co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

Ogivri is the first trastuzumab biosimilar approved in Canada and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the market.

The approval by Health Canada was based on robust data from structural and functional characterization using multiple orthogonal techniques, non-clinical studies and pharmacokinetic evaluation in healthy subjects and patients and a safety, efficacy and immunogenicity study in relevant patient populations, which compared Ogivri to Herceptin. The data, according to Biocon/Mylan, ‘demonstrated that Ogivri is highly similar to Herceptin with no clinically meaningful differences in terms of efficacy, safety, purity and potency’.

Biocon and Mylan’s trastuzumab biosimilar is currently approved in more than 65 countries around the world. The companies gained European approval in December 2018 [1], after a positive recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in October 2018 [2]. The pair also received approval for Ogivri (MYL‑1401O) from the US Food and Drug Administration (FDA) and from the Brazilian Health Surveillance Agency’s (Agência Nacional de Vigilância Sanitária, ANVISA) in December 2017 [3, 4].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Mylan gains nod for Ogivri and launches Hulio in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 7]. Available from: www.gabionline.net/Biosimilars/News/Mylan-gains-nod-for-Ogivri-and-launches-Hulio-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Ogivri [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Ogivri
4. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilars receive EMA and ANVISA approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 7]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilars-receive-EMA-and-ANVISA-approval

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Source: Biocon

Comments (1)

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