India-based companies Dr Reddy’s Laboratories (Dr Reddy’s) and Intas Pharmaceuticals are expected to start trials soon. Biocon has the head start, the company has already completed phase III trials of its ‘similar biologic’ trastuzumab and is expected to launch the product during financial year 2013.

Biocon’s Chairman & Managing Director, Ms Kiran Mazumdar-Shaw told Rebiff ‘We have completed the phase III trials and are awaiting the result. We are sure the product will be launched this financial year’. A Dr Reddy’s spokesperson told the Business Standard that ‘Dr Reddy’s does not share specifics of its portfolio’. They added that ‘molecules like trastuzumab are very much on our radar’.

An Intas spokesperson did not see any need for secrecy, stating that ‘trastuzumab is a critical molecule in the oncology pipeline at Intas and have been actively pursuing its development’.

Globally, South Korean biotechnology company Celltrion applied for approval of its trastuzumab biosimilar candidate CT-P6 with the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) on 4 June 2013 [2]. While US-based pharma giant Pfizer has also presented positive phase I data for its biosimilar trastuzumab candidate PF-05280014 [3].

So, while Roche had perhaps been counting on the fact that there are as yet no approved ‘similar biologics’ of trastuzumab in India to safeguard its sales there, the race is on and it may not be long before a competitor to Roche’s blockbuster enters the Indian market.

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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 Aug 30]. Available from: www.gabionline.net/Biosimilars/News/Roche-abandons-Herceptin-patent-in-India

2.  GaBI Online - Generics and Biosimilars Initiative. Celltrion applies for Korean approval of biosimilar trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Aug 30]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-applies-for-Korean-approval-of-biosimilar-trastuzumab

3.  GaBI Online - Generics and Biosimilars Initiative. Robust data for biosimilar trastuzumab programmes presented [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Aug 30]. Available from: www.gabionline.net/Biosimilars/Research/Robust-data-for-biosimilar-trastuzumab-programmes-presented

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