COFEPRIS approves bevacizumab Bhava and trastuzumab Mamitra biocomparables

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COFEPRIS approves bevacizumab Bhava and trastuzumab Mamitra biocomparables

Biosimilars/News | Posted 18/09/2024 0 Post your comment

In July 2024, the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk, Comisión Federal para la Protección contra Riesgos Sanitarios), approved two biocomparables – bevacizumab Bhava and trastuzumab Mamitra – from India-based Zydus.

Bhava
Bhava (bevacizumab) is approved for the treatment of 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.

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian [1].

Bhava is available in 100 mg/4 mL and 400 mg/16 mL.

Mamitra
Mamitra (trastuzumab) is approved for the treatment of patients with human epidermal growth factor receptor 2 (HER2) overexpressing metastatic breast cancer (MBC), HER2 overexpressing early breast cancer (EBC) and advanced gastric cancer.

Breast cancer has become the most diagnosed cancer in Mexico, overtaking prostate and colorectal cancers.

Trastuzumab is a monoclonal antibody that binds to and inactivates the HER2/neu receptor. In some cancers, notably certain types of breast cancers, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers [2].

Mamitra is available in 150 mg and 440 mg.

In 2015, Zydus developed and launched Bryxta, a 'similar biologic' bevacizumab, and in 2016, they launched Vivitra, a trastuzumab 'similar biologic'. Both were created in-house by the research team at the Zydus Research Centre in India.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety, and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘biocomparables’ approved in Mexico might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 18]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 18]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-trastuzumab

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