Court: No Herceptin Biosimilar Tag For Indian Trastuzumabs

 
• By Anju Ghangurde
  
Generate a summary of this article
Listen to this article
Beta

An Indian court appears to have delivered a frontal blow to defendants Biocon and Mylan in a hotly contested case concerning their biosimilar versions of Roche's Herceptin (trastuzumab).

The court has, in an interim ruling, suggested that the regulatory approvals for the biosimilars may not have been aligned with Indian guidelines for such products and that both Biocon and Mylan can keep their drugs on the market but can't call them biosimilar to Herceptin. The court even put forth an option for Biocon to reapply for its license should it wish to claim biosimilar as a description of its product or part of its promotional campaign.

The high-decibel case in the Delhi High Court pitches plaintiff Roche against the Drugs Controller General of India (DCGI) and...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

SpotifyApple PodcastsWebsite

More from Business

Test Roche Head Of Pharma Strategy Karsten Jung On Rebuilding The Portfolio

 
• By Jessica Merrill

The Swiss pharma company is rebalancing the portfolio, emphasizing best-in-class drugs and moving into new areas like cardiovascular and metabolic disease.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Reed Miller

In this week's episode: Trump’s UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year’s biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso’s goals beyond ivonescimab.

Article Without An Author Listed

Here is a short description.

Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

More from Scrip

EHA: Lilly’s Jaypirca Posts First Phase III Triplet Win In CLL While BTK Degraders Advance - Clone

Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.

Top 10 Drugs Q1 2026: New Sheriff In Town As Mounjaro Unseats Keytruda

Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains