Roche sues India’s drug regulator over Avastin ‘similar biologics’

Biosimilars/General | Posted 03/06/2016 post-comment0 Post your comment

Switzerland-based drug giant Roche has sued the Drug Controller General of India (DCGI) in the Delhi High Court over ‘similar biologic’ versions of its cancer blockbuster Avastin (bevacizumab).

Bevacizumab 1 V14f01

Roche is attempting to block any approval of a ‘biosimilar’ label for India-based Hetero Drugs bevacizumab ‘similar biologic’.

In April 2016, the Delhi High Court barred India-based biologicals specialist Biocon and US generics maker Mylan from using the label ‘biosimilar’ for their ‘similar biologic’ versions of Roche’s blockbuster breast cancer treatment Herceptin (trastuzumab). Biocon and Mylan, however, have insisted that the package insert was duly approved by the DCGI and claim that ‘unless the main approval or the approval for package insert is revoked or cancelled, we are entitled to use the same in their packaging while marketing the drug’ [1].

The move by Roche to sue the DCGI over ‘similar biologics’ of Avastin is seen as a pre-emptive strike to try to prevent competition for its originator product. Hetero Drugs, Intas Pharmaceuticals and Reliance Life Sciences are reported to also have ‘similar biologic’ bevacizumab ready for approval in India.

Roche has been under attack from health activists who see the company’s stand as a tactic to block competition from lower cost versions. However, Roche insists that its challenges are to ensure the safety of patients.

The patents on Avastin are set to expire in Europe in January 2022 and in the US in July 2019 [2].

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1. GaBI Online - Generics and Biosimilars Initiative. Biocon and Mylan challenge Indian ban on trastuzumab ‘similar biologics’ []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 3]. Available from:
2. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040

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Source: Economic Times India

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