Zydus Lifesciences Secures Mexican Approval for Cancer Biosimilar 'Bhava'

Zydus Lifesciences Ltd has received Mexican regulatory approval for its biosimilar product, Bhava, used in treating various cancers. This approval marks the company's first biosimilar entry into Latin America. Bhava, marketed in specific strengths, aims to provide affordable cancer therapies, developed in-house by Zydus Research Centre.

Zydus Lifesciences Ltd announced on Monday that they have been granted marketing approval from the Mexican regulatory authority for their biosimilar product, Bhava, used in the treatment of certain types of cancers.

The Mexican regulatory authority, COFEPRIS, has approved Bhava, a Bevacizumab biosimilar, which will be offered in strengths of 100 mg/4 ml and 400 mg/16 ml, as per Zydus Lifesciences' regulatory filing.

Bhava is indicated for use in multiple cancers including metastatic colorectal cancer, non-squamous non-small cell lung cancer, metastatic breast cancer, glioblastoma, and advanced renal cell carcinoma among others.

Zydus Managing Director, Sharvil Patel, said this is their first biosimilar for patients in Latin America. He emphasized the company's commitment to developing affordable cancer therapies and their strategy to support patients in Latin America.

Citing a WHO report from 2020, Zydus pointed out that breast, prostate, colorectal, and thyroid cancers are among the most common cancer cases in Mexico.

Zydus developed the Bevacizumab biosimilar in 2015, branded as 'Bryxta' in India, and has since treated an estimated 50,000 patients with it. The company has launched 12 lifesaving biosimilars to address the unmet need for affordable cancer therapies.

(With inputs from agencies.)