Approved for all indications of the innovator molecule including metastatic colorectal, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer
Bengaluru, India – November 27, 2017 – Mylan Pharmaceuticals Private Limited today announced the launch of ABEVMY® (Injection Bevacizumab 100 mg and 400 mg), an anti-angiogenic drug approved by the Drug Controller General of India (DCGI) for all indications of the Roche’s Avastin®, including for the treatment of metastatic colorectal, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of specific regimens for Indian patients.
The approval of ABEVMY® was supported by a comprehensive data package to prove biosimilarity including robust analytical, pharmacokinetic, and pharmacodynamic studies and an India-specific, randomized, double-blind clinical trial in metastatic colorectal cancer patients.
ABEVMY® is a recombinant “humanized” monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, thereby inhibiting tumor growth. An important benefit for patients is its price for each therapy cycle, which is comparatively lower than the existing options.
Commenting on the launch, Mr. Rakesh Bamzai, President, India and Emerging Markets said, “Advancements in research and development have made it possible to deliver better therapy outcomes that improve the quality of patient lives and expand access to treatment options. ABEVMY® is the second biosimilar that Mylan has launched to help improve affordability and access to essential oncology treatments in India. We’re proud to bring this product to market and remain deeply committed to serving this patient community through the introduction of biosimilars.”
According to data from the Indian Council of Medical Research, 1.45 million new cases of cancer in the country were reported in 2016. This figure is estimated to increase by approximately 1.73 million new cases annually by 2020.
Mylan’s oncology portfolio in India includes cytotoxic and targeted oncology therapies for common types of cancer.