Biocon and Mylan challenge Indian ban on trastuzumab ‘similar biologics’

Biosimilares/Novedades | Posted 28/02/2014 post-comment0 Post your comment

India-based biologicals specialist Biocon and US generics maker Mylan have challenged the Delhi High Court’s interim order that barred them from using Switzerland-based drug giant Roche’s data to sell their ‘similar biologic’ versions of Roche’s breast cancer blockbuster Herceptin (trastuzumab).

Clinical Trials 2 V13K29

The Delhi High Court had restrained Biocon and Mylan from claiming that their versions of the breast cancer drug are ‘biosimilars’ of Roche’s originator product [1]. The court stated that the companies should refrain from ‘relying upon’ or ‘referring to Herceptin’ or any data related to it for selling or promoting their brands Canmab (Biocon) and Hertaz (Mylan).

Roche has told the court that Biocon and Mylan’s drugs are being misrepresented as ‘biosimilar trastuzumab’ and ‘biosimilar version of Herceptin’ without following the due process in accordance with the guidelines on ‘similar biologics’ for gaining approval in India. Roche also claims that there is no public record, in India or elsewhere, to show that the two companies actually carried out phase I and phase II trials on their trastuzumab versions. Finally, Roche claims that Biocon and Mylan’s package inserts are a ‘slavish copy’ of the originator’s version. Roche also says that the claims made by Biocon and Mylan in the package insert go beyond, and are even contrary to, what the drug regulator had originally approved.

The Delhi High Court has said that it is not taking an immediate position on whether the two firms had the drug regulator’s approval for the package insert they were using to sell their ‘similar biologic’ version of trastuzumab. However, Biocon and Mylan are insisting that the package insert was duly approved by the Indian drug regulatory agency the Drug Controller General of India (DCGI).

Biocon and Mylan also state 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.’

Roche is also suing the DCGI for giving permission for the launch of the trastuzumab ‘similar biologics’, alleging that the regulator failed to follow due diligence and may have used Roche data when considering the applications. The case is due in court on 28 February 2014 [1].

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.

Related article

Mylan and Biocon to partner on biosimilar insulin products

Reference

1.   GaBI Online - Generics and Biosimilars Initiative. Roche wins case against Herceptin ‘similar biologics’ producers [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 28]. Available from: www.gabionline.net/Biosimilars/News/Roche-wins-case-against-Herceptin-similar-biologics-producers

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2014 Pro Pharma Communications International. All Rights Reserved.

Source: The Economic Times India

comment icon Comments (0)
Post your comment
Related content
La FDA aprueba el biosimilar pegfilgrastim Stimufend
Approved-V13G05
Biosimilares/Novedades Posted 07/10/2022
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010