Zydus Lifesciences Received Marketing Approval for Bhava™ Biosimilar in Mexico

Zydus Lifesciences Limited (Zydus) has achieved a significant milestone by securing marketing approval for its Bevacizumab biosimilar, Bhava™, from the Mexican regulatory authority, COFEPRIS (Federal Commission for the Protection Against Sanitary Risk). This approval marks Zydus’ continued commitment to providing patients worldwide with access to high-quality, affordable biosimilar treatments.

Bhava™ will be available in two strengths – 100 mg/4 ml and 400 mg/16 ml – addressing a critical need in treating various oncological indications, 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.

Addressing a Growing Need in Mexico

This approval is particularly relevant considering the cancer burden in Mexico. A 2020 World Health Organization (WHO) report highlights breast, prostate, colorectal, and thyroid cancers as some of the most prevalent in the country. Bhava™ offers a promising treatment option for patients battling these aggressive malignancies.

Legacy of Biosimilar Development

Zydus has a well-established track record in biosimilar development. Their in-house research team at the Zydus Research Centre (ZRC) spearheaded the creation of Bhava™, mirroring the success of Bryxta™, launched in India in 2015. Since its introduction, Bryxta™ has benefitted an estimated 50,000 patients in India, demonstrating Zydus’ dedication to improving affordability and access to life-saving cancer therapies.

Expanding Access to Biosimilars

With twelve biosimilars already commercially available, Zydus is emerging as a leader in bridging the gap for affordable cancer treatments. The Mexican approval for Bhava™ represents a step forward in their mission to extend the reach of these essential medications to a wider global audience.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus, said, “We welcome the approval granted to the first of our 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. With BhavaTM, we begin a new journey of supporting patients with need-based therapies in Latin America.”

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