India’s drug regulator, the Drugs Controller General of India (DCGI), has granted marketing approval for the world first trastuzumab ‘similar biologic’.
India-based Biocon announced on 26 November 2013 that the company had received Indian approval for its trastuzumab ‘similar biologic’, which has been developed jointly with generics giant Mylan. Biocon’s ‘similar biologic’ has been approved for the treatment of human epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer.
The news follows the decision by Swiss-based pharma giant Roche not to pursue its patent for its originator version of the drug, Herceptin (trastuzumab), in India [1]. This decision by Roche came after the Indian government announced that it was considering issuing more compulsory licenses and had Herceptin in its sights [2].
Breast cancer is one of the most common types of cancer in India with over 100,000 new breast cancer patients being diagnosed each year. Prices, however, for cancer drugs make getting treatment difficult for Indian citizens. The originator drug is reported to cost around US$3,000–US$4,500 (Rs 1.64–2.45 lakh) for a month’s treatment, making it unaffordable to many of India’s citizens [2]. It is therefore hoped that Biocon/Mylan’s trastuzumab ‘similar biologic’ will offer an alternative affordable option.
Biocon’s trastuzumab ‘similar biologic’ will be marketed in India under the brand name of CANMAb by Biocon and is expected to be available to Indian patients in the fourth quarter of 2014. Mylan intends to market its trastuzumab product under the trade name Hertraz and expects to launch the product in India in early 2014.
Trastuzumab is one of five biological products Mylan is developing in partnership with Biocon for the global marketplace. Mylan has exclusive commercialization rights for trastuzumab in Australia, Canada, Japan, New Zealand, US, and in the European Union and European Free Trade Association countries and co-exclusive commercialization rights with Biocon for the product in India.
According to Mylan’s press release, trastuzumab had 2012 sales in India of approximately US$21 million.
Other Indian companies also reported to be working on creating trastuzumab ‘similar biologics’ include Dr Reddy’s Laboratories and Intas Pharmaceuticals, both of which are expected to start trials soon [3].
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. Roche abandons Herceptin patent in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 29]. Available from: www.gabionline.net/Biosimilars/News/Roche-abandons-Herceptin-patent-in-India
2. GaBI Online - Generics and Biosimilars Initiative. India issues more compulsory licences [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 29]. Available from: www.gabionline.net/Policies-Legislation/India-issues-more-compulsory-licences
3. GaBI Online - Generics and Biosimilars Initiative. Indian firms chasing ‘similar biologic’ Herceptin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 29]. Available from: www.gabionline.net/Biosimilars/News/Indian-firms-chasing-similar-biologic-Herceptin
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