US approves its first cancer biosimilar, India has several already

The United States of America is now for the first time getting a taste of a locally approved biosimilar drug for treating cancer. What it can do by way of lowering of drug prices, the various other advantages and challenges that come with it. This follows the announcement by the US drug regulator, the USFDA (US Food and Drug Administration) on Thursday, September 14th that it has approved the first biosimilar for the treatment of cancer. The regulator has approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) - Innovator company Roche - for the treatment of multiple types of cancer. "Mvasi", a note issued by the USFDA says, "is the first biosimilar approved in the U.S. for the treatment of cancer." Then, the USFDA commissioner Scott Gottlieb is quoted as saying: "Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies." He further says: "We'll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA's rigorous gold standard for safety and effectiveness." This may be good news for Indian companies wanting to launch biosimilars in the US. As against innovator drug, biosimilars, as many know, are very loosely the generic drug equivalents in the biotech drug space
For good or for bad, depending on who is viewing it, India has taken a lead here and going by the official figures, there are around 24 biosimilar drugs in all that have already been approved by the Indian regulator since 2011. In fact, for this very innovator drug, Avastin, doctors talk of some half a dozen biosimilars already available in the Indian market and being sold at as low as half the price. With a biosimilar policy also in place, what India may want to focus only on, as doctors say, is to ensure a constant eye on quality and on the clinical trials, as they hold the key in biotech drugs.
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The development on this front in the US needs to be watched closely. For, it may be an exciting piece of news for patients and insurance companies since there is competition leading to lowering of cancer drug prices. What however needs to be seen is how it will play out and the response of the innovator companies, for whom many of their drugs are leading products in the market. Avastin for instance is one of the top selling drugs of Roche.
Mvasi, the USFDA note exaplains, is a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers.
It however adds a word of caution: "Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses." And says: "Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law." And that the "FDA's approval of Mvasi is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Mvasi is biosimilar to Avastin. It has been approved as a biosimilar, not as an interchangeable product."
The FDA, it adds, "granted approval of Mvasi to Amgen, Inc. Avastin was approved in February 2004 and is manufactured by Genentech, Inc" (a member of the Roche Group).
Meanwhile, Amgen, in a media release issued on the same day said: Amgen and Allergan plc.announced that the U.S. Food and Drug Administration has approved MVASI (bevacizumab-awwb) for all eligible indications of the reference product, Avastin (bevacizumab). MVASI is the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, approved by the USFDA. MVASI is approved for the treatment of five types of cancer, including in combination with chemotherapy for non-squamous non-small cell lung cancer (NSCLC), in combination with chemotherapy for metastatic colorectal cancer (mCRC), glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa and in combination with chemotherapy for persistent, recurrent, or metastatic carcinoma of the cervix." And added this quote: "The approval of MVASI marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar approved in the United States," said Sean E. Harper, executive vice president of Research and Development at Amgen. "With decades of experience in oncology and biologics, Amgen continues to expand its biosimilar and oncology portfolios, and MVASI has the potential to advance access to high-quality, targeted cancer therapy."


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