Indian Court Lifts Restrictions on Biosimilars of Roche’s Herceptin

The Delhi High Court is allowing two drugmakers to market and produce biosimilar versions of Roche’s Herceptin to treat three cancers.

The ruling comes less than a year after the court gave Biocon and Mylan’s Indian subsidiary permission to sell the Herceptin biosimilars to treat one form of cancer, but prohibited the companies from referring to their products as biosimilars or otherwise linking them to Roche’s Herceptin in labeling or promotions.

Biocon and Mylan can now market their Herceptin biosimilars as treatments for metastatic and early breast cancer, as well as metastatic gastric cancer.