Zydus Lifesciences Ltd announced on Monday that it has secured marketing approval from the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk) for its biosimilar product Bhava. This biosimilar is used to treat various types of cancers, marking a significant step for the company in expanding its reach to Latin American markets.
Bhava, a biosimilar of Bevacizumab, will be available in two strengths: 100 mg/4 ml and 400 mg/16 ml. Bevacizumab is a monoclonal antibody that interferes with the growth of cancer cells by inhibiting angiogenesis, the process by which new blood vessels form from pre-existing vessels. This mechanism is crucial in the treatment of cancers where the growth of new blood vessels is essential for tumor growth and metastasis.
With COFEPRIS’s approval, Zydus can now commercialize Bhava for a number of cancer indications, such as ovarian cancer, advanced and/or metastatic renal cell carcinoma, glioblastoma, non-squamous non-small cell lung cancer, metastatic breast cancer, and metastatic colorectal cancer (mCRC). These are important sectors with a strong need for therapies that are both affordable and effective.
Sharvil Patel, Managing Director of Zydus Lifesciences, emphasized the significance of this approval. He said this is the first biosimilar the business has been able to get licensed for use by patients in Latin America. Patel stressed the company’s dedication to lowering the cost and increasing the accessibility of cutting-edge cancer therapies. He mentioned that Zydus has made the development of biosimilars a strategic priority, with a focus on oncology in particular. By offering accessible treatments and accurate diagnosis, this strategy seeks to equip millions of people with vital resources for the battle against cancer.
Zydus cited a 2020 World Health Organization (WHO) study to highlight the incidence of several cancer kinds in Mexico. According to the research, the most often diagnosed cancers in the nation are thyroid, colorectal, breast, and prostate cancers. It is anticipated that Bhava’s entry into the Mexican market will address a few of these common cancer types and provide patients with additional therapy alternatives.
The business has experience creating and introducing biosimilars. The Zydus Research Centre (ZRC) originally developed and introduced Bhava in India in 2015 under the brand name Bryxta. This medication has been used to treat about 50,000 people in India since its debut. Zydus is credited with helping to close the affordability gap for cancer treatments in India with the launch of twelve life-saving biosimilars.
Zydus has achieved a noteworthy milestone with this new approval in Mexico, further expanding its influence in the global healthcare arena. The company’s endeavors to offer economically viable cancer therapies demonstrate its dedication to meeting the unfulfilled requirements of people suffering from severe illnesses. This action advances Zydus’s goal to improve patient care globally by fortifying its position in the Latin American market and establishing a standard for upcoming approvals and growth in other areas.
SOURCE:
BUSINESS STANDARD
