Zydus Life Wins Mexico Regulator's Approval to Market Bhava
Zydus Lifesciences announced on Monday, July 22, that it has gained approval from the Mexican regulator COFEPRIS to market Bhava, which will be used to treat a variety of tumors.
Key Takeaways from Zydus Lifesciences Nod on Bhava:
- Zydus Lifesciences on Monday, gained approval from the Mexican regulator COFEPRIS to market Bhava, to treat a variety of tumors.
- Bevacizumab biosimilar Bhava is offered in two dosage forms, 100 mg/4 ml and 400 mg/16 ml.
- Glioblastoma, advanced and/or metastatic renal cell carcinoma, ovarian cancer, non-squamous non-small cell lung cancer, metastatic breast cancer, and other cancers will all be treated with it.
Bhava is a biosimilar to Bevacizumab and will be available in two strengths: 100 mg/4ml and 400 mg/16ml.
Zydus Life stated that the medicine is used to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer, metastatic breast cancer, glioblastoma, advanced and/or metastatic renal cell carcinoma, and ovarian cancer.
Zydus Life's Managing Director, Sharvil Patel, stated that the business has been creating a pipeline of biosimilars, particularly in cancer, to increase access and cost for patients suffering from essential illnesses. "Precision diagnostics and cheap medicines are empowering millions of cancer patients in India. "With Bhava, we embark on a new journey of providing patients with need-based therapies in Latin America," Patel added.
The USFDA issued two observations to Zydus Life last week for its transdermal manufacturing location at the Ahmedabad Special Economic Zone.
The US agency conducted an examination at the facility from July 15 to 19, 2024, and concluded with two observations. The company stated that it is confident in its ability to address the issues mentioned by the USFDA within the time frame specified and is dedicated to resolving them as soon as possible.
According to a WHO 2020 report, the most prevalent cancers reported in Mexico were breast, prostate, colorectal, and thyroid.
In 2015, Zydus developed and marketed Bryxta, a Bevacizumab biosimilar in India. The Zydus Research Centre is where it originated. The therapy has subsequently treated an estimated 50,000 individuals, according to the business.
About Zydus Lifesciences Limited
Zydus Lifesciences Limited, a leading Indian Pharmaceutical company is a fully integrated, global healthcare provider. Zydus has domain expertise in the field of healthcare, it has strong capabilities across the spectrum of the pharmaceutical value chain. Among Indian pharmaceutical businesses, Zydus is known for offering full and comprehensive healthcare solutions, including wellness products, active pharmaceutical ingredients, formulations, and animal healthcare products.
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