Mylan and Biocon submit trastuzumab biosimilar to EMA

Biosimilars/News | Posted 09/09/2016 post-comment0 Post your comment

Mylan and Biocon announced on 25 August 2016 that the regulatory submission for their proposed trastuzumab biosimilar (MYL-1401O) had been accepted for review by the European Medicines Agency (EMA).

Application V15a16

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 over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

The originator product, Roche’s Herceptin (trastuzumab), had 2014 worldwide sales of CHF 6.3 billion (US$6.2 billion) making it a lucrative target for biosimilars developers. The patents on Herceptin expired in Europe in July 2014 and will expire in the US in June 2019 [1].

The application is based on analytical, functional and preclinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trials for trastuzumab. The PK study has, according to Biocon and Mylan, ‘demonstrated measured bioequivalence’ of MYL-1401O ‘relative to that of the reference drug’. The second study, the ‘HERiTAge Study’, ‘confirmed the efficacy, safety and immunogenicity’ of MYL-1401O compared to Roche’s Herceptin [2].

Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs [3]. The proposed biosimilar pegfilgrastim is one of six biologicals being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar pegfilgrastim in Australia, Canada, Japan, New Zealand, the US and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

In fact, Biocon has already been marketing a trastuzumab ‘similar biologic’ in India since 2013 under the trade name CanMab [4].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related article
Biosimilars of trastuzumab

1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 9]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Mylan presents comparability data for trastuzumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 9]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to parter on insulin products []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 9]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 9]. Available from:

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Source: Biocon, Mylan

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