Zydus Lifesciences Limited has announced that its Bevacizumab biosimilar, BhavaTM, has received marketing approval from Mexico's regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk). This marks a significant milestone for the pharmaceutical company as it expands its presence in Latin America.

BhavaTM, available in strengths of 100 mg/4 ml and 400 mg/16 ml, is set to address several critical cancers including 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. This approval is timely, given that, according to a WHO report from 2020, breast, prostate, colorectal, and thyroid cancers are among the most prevalent in Mexico.

Dr. Sharvil Patel, Managing Director of Zydus, expressed enthusiasm about the approval. “We welcome the approval granted to the first of our biosimilars for patients in Latin America. To bring 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. With BhavaTM, we begin a new journey of supporting patients with need-based therapies in Latin America,” he said.

BhavaTM follows the successful launch of Zydus’s Bevacizumab biosimilar, BryxtaTM, in India in 2015. Developed in-house at the Zydus Research Centre (ZRC), BryxtaTM has since treated approximately 50,000 patients. Zydus has launched twelve lifesaving biosimilars to date, addressing the significant demand for affordable cancer therapies in India.

The approval of BhavaTM represents a key step in Zydus's ongoing mission to bridge the gap in affordable cancer treatments globally, expanding its reach to meet the needs of patients across different regions.