Lawyers for Roche, Biocon trade contempt charges in Herceptin biosim case

(Getty Images) Gavel

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.

Upcoming Webinar

Lifecycle Management Strategies Targeted For Patient Populations with Swallowing Disorders

Hear from industry experts as they discuss life cycle management strategies for patients with swallowing disorders and the overall impact on patient perception. The webinar will include several panel speakers representing different perspectives and case study examples. Save your spot and register today!

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

Related Articles:
India's Hetero launches Avastin biosimilar, following Reliance into the market
India's Reliance Life Sciences brings first bevacizumab biosim to market
India tweaks biosimilar guidelines to narrow waivers in clinical trials
India's Biocon chief notes plans for biosimilar plays in EU, U.S.
Will biosim naming hit Roche’s Avastin rep? Delhi Court doesn’t buy it
Roche presses on biosimilar labels in India with Avastin challenge
Biocon, Mylan plan appeals of Delhi court ruling on biosimilar


Suggested Articles

Creating a relevant online health user experience has its payoffs — for both the user and the brand. Here’s why.

Sanofi's new strategy delivered for the drugmaker in the third quarter as Dupixent posted blockbuster sales and flu vaccines set a revenue record.

Catalent has acquired Bone Therapeutics' cell and gene therapy site in Gosselies, Belgium, to add to its growing "center of excellence" there.