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Biosimilars Forum launches access, awareness initiative

BY David Salazar

WASHINGTON — The Biosimilars Forum launched Monday its new Partnership for Biosimilars Education and Access. The new initiative is aimed at raising awareness off and increasing access to biosimilars, and its launch was accompanied by the release of two education guides for health care professionals, patient advocacy groups and the media on the group’s website.  
 
“We know that some of the most difficult diseases that afflict people in the U.S. are best treated with biological medicines,” Biosimilars Forum president Juliana Reed said. “The introduction of biosimilars is anticipated to help drive lower cost burdens for the U.S. health care system. It will also help expand earlier, more consistent access to these important medicines for patients with cancer, anemia, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, psoriasis, and Crohn's and other inflammatory bowel diseases.”
 
The first U.S. biosimilar, Zarxio (filgrastim-sndz) was approved by the Food and Drug Administration and launched by Sandoz in 2015.
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NABP expands list of ‘not recommended’ websites

BY David Salazar

MOUNT PROSPECT, Ill. — The National Association of Boards of Pharmacy (NABP) released a new report about illegal online sellers of drugs and the need to combat them and their role in the opioid epidemic. “Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: January 2016” expands the number of websites the NABP classifies as “not recommended,” growing that list to 10,668 sites. 
 
The list of “not recommended” sites  — which was begun in 2008 — documents those that sell medication in a way that isn’t in compliance with federal and state laws or the NABP patient safety and pharmacy practice standards. NABP said that 60% of the sites don’t have a location on their website, which is done to sell counterfeit medication, and 50% offer drugs that are foreign or haven’t received Food and Drug Administration approval. 
 
NABP, in an attempt to make it easy for patients to figure out legitimate medication sellers, is also issuing Top-Level Domain names to pharmacies that qualify, giving them a .pharmacy domain (as opposed to .com or .net) to signify their legitimacy. Currently NABP has approved 351 domain names, with such companies as CVS, Express Scripts and Rite Aid having registered. 
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Dr. Reddy’s gets tentative FDA approval for generic Zenavod

BY David Salazar

SILVER SPRING, Md. — The Food and Drug Administration on Monday gave tentative approval to Dr. Reddy’s Laboratories’ generic version of Zenavod (doxycycline) capsules. 
 
The drug is intended to treat inflammatory lesions of rosacea in adults and will be available in 40-mg capsules once it is given final approval. 
 
The approval is tentative due to an ongoing patent infringement process under the Drug Price Competition and Patent Term Restoration Act, the company said. The drug has met agency’s safety, quality and efficacy standards. 
 
“We are pleased to receive a tentative FDA approval of Zenavod and will be working with external parties and the FDA to gain a full approval,” Dr. Reddy's CEO and co-chairman G.V. Prasad said. 
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