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Indian drugmakers make progress with candidate biosimilars Posted 05/06/2015

India-based biologicals specialist Biocon announced on 7 May 2015 that it had made clinical progress in its partnered programmes with US generics maker Mylan.

The Biocon/Mylan partnership now has global phase III clinical trials ongoing for candidate biosimilars of adalimumab, bevacizumab, pegfilgrastim and trastuzumab.

Two global clinical trials for their candidate biosimilar insulin glargine initiated in 2014, have also made significant progress. The patient recruitment for the Type-1 diabetes study has been completed ahead of schedule, while the recruitment for the Type-2 diabetes study is expected to be completed by July 2015.

Meanwhile, rival Indian drugmaker Intas Pharmaceuticals (Intas) launched its ‘similar biologic’ of etanercept (Intacept) in India in March 2015. The company says this is the 'first biosimilar' of Amgen’s Enbrel (etanercept).

Etanercept is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis, all debilitating autoimmune diseases.

Intas expects, through the introduction of Intacept, to be able to reduce the cost of treatment for patients to about half that of the imported Enbrel.

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
Mylan and Biocon to partner on biosimilar insulin products

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Source: Biocon, Intas

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