The Drugs Controller General of India (DCGI) approved the traztuzumab ‘similar biologic’ in November 2013 for the treatment of human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer [1]. About 25% of breast tumours are distinguished by the HER2 protein on the surface of the cancer cells, which causes them to multiply more quickly. Trastuzumab latches on to HER2, interfering with it without killing the cell. The drug is Mylan’s first ‘similar biologic’ to hit the market of India and is reported by the company to be the 'world’s first trastuzumab biosimilar’.

The announcement comes in the wake of Mylan’s partner Biocon’s announcement that it was introducing its trastuzumab ‘similar biologic’ CANMAb to the Indian market in February 2014 [2].

Trastuzumab is one of five biologicals that Mylan is developing in partnership with Biocon for the global marketplace. Mylan has exclusive commercialization rights for biosimilar trastuzumab in Australia, Canada, the European Union, the European Free Trade Association countries, Japan, New Zealand and the US, and co-exclusive commercialization rights with Biocon for ‘similar biologic’ trastuzumab in India.

Mylan and Biocon also have a deal to develop and market Biocon’s biosimilar versions of three insulin analogue products – Eli Lilly’s Humalog (insulin lispro), Novo Nordisk’s NovoLog (insulin aspart) and Sanofi’s Lantus (insulin glargine) [3].

Although the Indian market for trastuzumab is relatively small, with 2012 sales of the originator product Roche’s Herceptin reaching approximately US$21 million, Herceptin’s worldwide sales for 2013 reached an impressive US$6.8 billion.

The Indian market opened up for trastuzumab ‘similar biologics' when Switzerland-based pharma giant Roche decided not to pursue its patent for Herceptin in India after the Indian Government announced that it was considering issuing more compulsory licenses and had Herceptin in its sights [4]. In Europe and the US, Herceptin will face patent expiration in July 2014 and June 2019, respectively [5].

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 EU. EMA 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.

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Indian regulator approves first trastuzumab ‘similar biologic’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/Indian-regulator-approves-first-trastuzumab-similar-biologic

2.  GaBI Online - Generics and Biosimilars Initiative. Trastuzumab similar biologic to be launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-similar-biologic-to-be-launched-in-India

3.  GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to parter on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products

4.  GaBI Online - Generics and Biosimilars Initiative. India issues more compulsory licences [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Policies-Legislation/India-issues-more-compulsory-licences

5.  GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

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