The news follows approval of the ‘similar biologic’ by the Drugs Controller General of India (DCGI) in November 2013 [1]. The ‘similar biologic’ has been developed jointly with generics giant Mylan and has been approved for the treatment of human epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer.

Breast cancer is the most prevalent cancer among Indian women. Approximately 150,000 new patients are diagnosed with breast cancer every year in India, of which nearly 25% of cases are HER2+ and eligible for treatment with CANMAb. Although this number is expected to be higher as lack of affordable treatment options have limited testing for HER2+ patients.

CANMAb is a ‘similar biologic’ of Roche’s blockbuster cancer drug Herceptin (trastuzumab). The originator drug costs 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]. However, Biocon’s trastuzumab ‘similar biologic’ will offer an alternative affordable option, being marketed at about 25% discount to the current list price of the reference product in India.

Although the Indian market for trastuzumab is relatively small, with 2012 sales of approximately US$21 million, Biocon may have its eye on the global market, where Herceptin achieved sales of US$6.8 billion in 2013. This is backed by the fact that the multi-centre clinical trial carried out in India to support the regulatory approval for CANMAb followed international regulatory and quality guidelines.

CANMAb was expected to be available to Indian patients only in the fourth quarter of 2014, but now Biocon says it will be available to patients around the first week of February 2014.

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 Jan 24]. Available from: www.gabionline.net/Biosimilars/News/Indian-regulator-approves-first-trastuzumab-similar-biologic

2.  GaBI Online - Generics and Biosimilars Initiative. India issues more compulsory licences [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Policies-Legislation/India-issues-more-compulsory-licences

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