FDA approves first biosimilar drug for cancer

September 15, 2017

(HealthDay)—The first biosimilar drug to treat cancer has been approved by the U.S. Food and Drug Administration.

Mvasi (bevacizumab-awwb) was found to be biosimilar to the drug Avastin (bevacizumab), the FDA said Thursday in a news release. Avastin was approved in 2004. Mvasi is approved to treat certain colorectal, lung, brain, kidney, and cervical cancers.

The most common side effects of Mvasi include epistaxis, headache, hypertension, rhinitis, proteinuria, changes in taste, and dry skin. More serious could include perforation or fistula, arterial and venous thromboembolic events, and posterior reversible encephalopathy syndrome. Like Avastin, labeling for Mvasi will warn of increased risk of gastrointestinal perforations; complications after surgery; and severe or fatal pulmonary, gastrointestinal, central nervous system, and vaginal hemorrhage.

"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 and increase access to important therapies," FDA Commissioner Scott Gottlieb, M.D., said in a statement. He pledged new biosimilar drugs would be brought to market quickly, although subject to the FDA's "rigorous gold standard for safety and effectiveness."

Mvasi's approval was given to Amgen, based in Thousand Oaks, Calif. Avastin is produced by Genentech.

Explore further: FDA clears Avastin for late-stage cervical cancer

More information: More Information

Related Stories

FDA clears Avastin for late-stage cervical cancer

August 15, 2014
The Food and Drug Administration has approved Genentech's Avastin for a new use against late-stage cervical cancer, the sixth indication for the blockbuster biotech drug.

FDA approves Roche's Avastin for ovarian cancer

November 14, 2014
Swiss drugmaker Roche said Friday that the Food and Drug Administration approved its drug Avastin as a treatment for ovarian cancer.

Court ruling clears way for Novartis' low-cost biotech drug

July 21, 2015
A federal appeals court has ruled that Novartis can begin selling its lower-cost copy of an Amgen Inc. drug in September, rejecting a bid to further delay the launch of the knock-off biotech medication.

Novartis wins US OK for biosimilar version of Amgen's Enbrel

August 30, 2016
U.S. regulators have approved the first near-copy of Enbrel, drugmaker Amgen's pricey biologic medicine for treating rheumatoid arthritis and other immune system disorders.

FDA approves first biosimilar drug in US

March 8, 2015
(HealthDay)—The U.S. Food and Drug Administration has approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.

Roche warns of counterfeit cancer drug in US

February 14, 2012
(AP) -- The maker of the best-selling cancer drug Avastin is warning doctors and patients about counterfeit vials of the product distributed in the U.S.

Recommended for you

Health insurer policies may discourage use of non-opioid alternatives for lower back pain

October 5, 2018
Public and private health insurance policies in the U.S. are missing important opportunities to encourage the use of physical therapy, psychological counseling and other non-drug alternatives to opioid medication for treating ...

Opioid overdoses, depression linked

October 3, 2018
The link between mental health disorders and substance abuse is well-documented. Nearly one in 12 adults in the U.S is depressed, and opioid-related deaths are skyrocketing. As these numbers continue to climb, some mental ...

Do price spikes on some generic drugs indicate problems in the market?

October 1, 2018
A new USC study reports that sudden price spikes for some generic drugs—such as the recently reported increases of a decades-old generic heart medication and an antibiotic—are becoming more common.

Reclassification recommendations for drug in 'magic mushrooms'

September 26, 2018
In an evaluation of the safety and abuse research on the drug in hallucinogenic mushrooms, Johns Hopkins researchers suggest that if it clears phase III clinical trials, psilocybin should be re-categorized from a schedule ...

New study finds concurrent use of prescription drugs and dietary supplements could pose health risks

September 25, 2018
A new University of Hertfordshire study found that using certain over-the-counter herbal medicines and dietary supplements alongside prescription drugs could pose serious health risks, especially amongst older adults.

Drug overdose epidemic has been growing exponentially for decades

September 20, 2018
Death rates from drug overdoses in the U.S. have been on an exponential growth curve that began at least 15 years before the mid-1990s surge in opioid prescribing, suggesting that overdose death rates may continue along this ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.