Zydus secures COFEPRIS approval for Bhava Biosimilar in Mexico

23 Jul 2024 , 02:07 PM

On July 22, 2024, Zydus Lifesciences announced that it has received approval from Mexico’s regulatory authority, COFEPRIS, to market Bhava, a Bevacizumab biosimilar.

Bhava will be available in two strengths: 100 mg/4 ml and 400 mg/16 ml. It is designed to treat various cancers, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, metastatic breast cancer, glioblastoma, advanced or metastatic renal cell carcinoma, and ovarian cancer.

According to a 2020 WHO report, the most common types of cancer in Mexico include breast, prostate, colorectal, and thyroid cancers.

Zydus Lifesciences initially developed and launched the Bevacizumab biosimilar in India in 2015 under the brand name Bryxta, following research at the Zydus Research Centre. Approximately 50,000 patients have been treated with this therapy since its introduction.

Sharvil Patel, Managing Director of Zydus Lifesciences, emphasized the company’s commitment to expanding its biosimilar pipeline, particularly in oncology. He stated that Bhava represents a significant step in providing affordable, need-based therapies to patients in Latin America.

At the time of writing on July 23, 2024 at 2:00 pm shares of Zydus Lifesciences is  currently trading at ₹1150 which is a 0.39% dip than the previous close. Zydus Lifesciences stock has gained a total of 87% in the last one year, and witnessed a 64% gain since the beginning of the year.

Last week, Zydus Lifesciences received two observations from the USFDA regarding its transdermal manufacturing site in the SEZ at Ahmedabad. The inspection took place from July 15 to 19, 2024. The company expressed confidence in addressing the observations within the required timeline and is dedicated to resolving the issues promptly.

Zydus Lifesciences, previously known as Cadila Healthcare Limited, is a major Indian multinational pharmaceutical company headquartered in Ahmedabad. The company focuses on the manufacturing of generic drugs and is listed at 100th position in the Fortune India 500 list as of 2020.