Zydus Lifesciences gets Mexican regulatory nod for cancer treatment biosimilar

Zydus Lifesciences Ltd on Monday said it has received marketing approval from the Mexican regulatory authority for its biosimilar product -- Bhava, used in the treatment of certain types of cancers.

Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval for Bhava, a Bevacizumab biosimilar and it will be marketed in different strengths of 100 mg/4 ml and 400 mg/16 ml, Zydus Lifesciences said in a regulatory filing.

Bhava is used in the treatment of metastatic colorectal cancer (mCRC), non-squamous non-small cell lung cancer, metastatic breast cancer, glioblastoma, advanced and/or metastatic renal cell carcinoma and ovarian cancer patients, it added.Zydus Managing Director, Sharvil Patel said the approval granted by COFEPRIS is the company's first biosimilars for patients in Latin America.

"To bring in greater access and affordability to patients battling critical ailments, we have been developing a pipeline of biosimilars, specifically in oncology. Precision diagnostics and access to affordable therapies are empowering millions of patients in their fight against cancer in India," he said, adding with Bhava, the company would begin a new journey of supporting patients with need-based therapies in Latin America.

Citing a WHO report of 2020, the company said out of the total cancer cases reported in Mexico, breast, prostate, colorectal and thyroid were amongst the common cancer cases registered.

Zydus said it had developed and launched the Bevacizumab biosimilar developed in-house by the research team at the Zydus Research Centre (ZRC) in 2015 in India under the brand name 'Bryxta'.

Since then, an estimated 50,000 patients have been treated with the therapy, Zydus said, adding with 12 lifesaving biosimilars already launched in the market, it has been bridging the unmet need for affordable therapies in the fight against cancer in India.