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).
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.
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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
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Source: The Economic Times India
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