A long-running court case filed in India by Roche ($RHBBY) seeking to prevent the use of label language by Bangalore-based Biocon and Mylan ($MYL) from claiming similarity to its aging breast cancer med Herceptin (trastuzumab) has turned tense--with both sides now seeking contempt-of-court charges.
In the case of Roche, the Economic Times reports that the Swiss firm said Biocon "violated a previous court order" temporarily barring any claims to similarity by using such language in a presentation at an international scientific conference on clinical trials with trastuzumab.
At the same time, Biocon accused Roche of "disparaging statements" about the company as part of a campaign to block approval efforts for a trastuzumab biosimilar by Biocon in other countries, the Economic Times said--noting that Phase III trials are underway in the U.S. for a version of the breast cancer therapy.
The Economic Times said Judge Hima Kohli sought responses from legal counsels for both sides on the charges, and that the case will be next heard in November.
At the heart of the case is a Delhi High Court judgment in April that Biocon and U.S.-listed Mylan could not use the label biosimilar for versions of Roche's med.
Both companies are appealing the ruling, which Roche hailed at the time, and can continue to market the products with revised labels and packaging.
The Roche original version is marketed in India as Herclon.
Meanwhile, Reliance Life Sciences has obtained a package insert approval for its biosimilar version of Herceptin named TrastuRel, along with another Indian firm, Zydus Cadila, for its Vivitra version.
Roche has already fought a similar action with its multilicensed cancer drug Avastin (bevacizumab) biosimilar in India, with Hetero Drug and Reliance Life Sciences already selling versions--though label changes were reportedly made.
The approvals for the biosimilars in both cases by the Drug Controller General of India caught flak as well for use of clinical studies by the originator in applications.
That issue apparently had an impact on new biosimilar guidelines published by India that narrowed the grounds for the regulator to waive comparative safety and efficacy studies to what were termed “exceptional cases.”
Neither firm was available for comment on the case, citing the ongoing hearings.
- here's the story from the Economic Times
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