Zydus Lifesciences gets approval from Mexican authority to market cancer treatment drug

Zydus Lifesciences informed the exchanges in a filing that the Mexican regulatory authority, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS), has granted marketing approval for Bhava, a cancer treatment drug.

The company said that Bhava is a Bevacizumab biosimilar and will be marketed in 100 mg/4 ml and 400 mg/16 ml dosages. The drug is used to treat 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.

In the total cases of cancer reported in Mexico, breast, prostate, colorectal and thyroid cancer were among the common categories, as per a WHO report from 2020.

The company informed the stock exchanges that it developed and launched the Bevacizumab biosimilar, which was developed in-house by the research team at the Zydus Research Centre (ZRC) in 2015 in India under the brand name Bryxta.  

Since its development nearly 50,000 patients have been treated with the therapy. Zydus also said in the release that twelve life saving biosimilars of Bevacizumab have already been launched in the market.

On July 19, the company informed the exchanges in a separate filing that the USFDA has successfully conducted an inspection at Zydus Lifesciences’ transdermal manufacturing site located at SEZ in Ahmedabad.

The company said that the inspection was conducted from July 15 to July 19 and concluded with two observations. The pharmaceutical company said that it is confident of addressing the issues raised by the USFDA within the stipulated timeline and is committed to resolving them as soon as possible.

Zydus Lifesciences Limited is a leading Indian Pharmaceutical company and a fully integrated, global healthcare provider. The company’s product portfolio includes formulations, active pharmaceutical ingredients, animal healthcare products and wellness products, according to the company’s website.

Shares of Zydus Lifesciences traded at ₹1,154 apiece, up 0.87%, on the NSE at 12:30 pm.