28
Jun
2016
Case Study: Hetero’s launch of Biosimilar ‘Bevacizumab’ Brand ‘Cizumab’ in India
Hetero, one of India’s leading generic pharmaceutical companies, today announces the launch of Biosimilar ‘Bevacizumab’ in India for the treatment of metastatic colorectal cancer (mCRC) under the brand name ‘Cizumab‘.Cizumab brand name filed for trademark registration on 18th of December, 2015.
The product has been approved by Drug Controller General of India (DCGI) and has been recommended as a first-line treatment for mCRC. The product will be made available to patients in a single dose vial with two strengths, 100 mg and 400 mg. It will be marketed and distributed by Hetero Healthcare Limited, a group company of Hetero.
Hetero is one of India’s leading generic pharmaceutical companies and is one of the world’s largest producers of anti-retroviral drugs for the treatment of HIV/AIDS. With more than 20 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include APIs, finished formulations and biosimilars. Hetero also offers custom pharmaceutical services to its partners around the world. The company is recognized for its strengths in Research & Development, manufacturing and commercialization of a wide range of products.
Hetero has more than 25 state-of-the-art manufacturing facilities strategically located worldwide. Majority of our facilities have been successfully audited and approved by various regulatory authorities like US-FDA, EU, TGA – Australia, MCC – South Africa and others. Our portfolio includes more than 200 products, encompassing major therapeutic categories such as HIV/AIDS, oncology, cardiovascular, neurology, hepatitis, etc.
Bevacizumab, sold under the trade name Avastin, is an angiogenesis inhibitor, a drug that slows the growth of new blood vessels.
The first approved indication came in 2004 for metastatic colorectal cancers, which remains a cancer type that responds well to Avastin. The overwhelming data of trials for usage of Avastin with a fluoropyrimidine demonstrates its efficacy and safety, which continually extends survival for this group of patients.
Major Clinical Approval and Bevacizumab Regulation Snapshot:
Bevacizumab is a recombinant humanized monoclonal antibody and in 2004 it became the first clinically used angiogenesis inhibitor. Its development was based on the discovery of human vascular endothelial growth factor (VEGF), a protein that stimulated blood vessel growth, in the laboratory of Genentech scientist Napoleone Ferrara. Ferrara later demonstrated that antibodies against VEGF inhibit tumor growth in mice. His work validated the hypothesis of Judah Folkman, proposed in 1971, that stopping angiogenesis might be useful in controlling cancer growth.
In 2008, the FDA gave bevacizumab provisional approval for metastatic breast cancer, subject to further studies.
The FDA’s advisory panel had recommended against approval. In July 2010, after new studies failed to show a significant benefit, the FDA’s advisory panel recommended against the indication for advanced breast cancer. Genentech requested a hearing, which was granted in June 2011. The FDA ruled to withdraw the breast cancer indication in November 2011. FDA approval is required for Genentech to market a drug for that indication. Doctors may sometimes prescribe it for that indication, although insurance companies are less likely to pay for it.
The drug remains approved for breast cancer use in other countries including Australia. It has been funded by the English NHS Cancer Drugs Fund but in January 2015 it was proposed to remove it from the approved list.
Also read >> Maball of Hetero
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