Sandoz starts phase-3 trial of biosimilar anemia drug
HOLZKIRCHEN, Germany — Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.
Sandoz, the generics arm of Swiss drug maker Novartis, said it had started enrolling patients for a phase-3 study of epoetin alfa, a biosimilar version of Epogen and Procrit, made by Amgen and Johnson & Johnson and used to treat anemia associated with chronic kidney disease.
“This latest study further reinforces Sandoz’s strong commitment to increasing access to high-quality, affordable biopharmaceuticals and further expanding our biosimilars business,” Sandoz head of biopharmaceuticals and oncology injectables Ameet Mallik said. “Sandoz is looking forward to bringing the benefits of a high-quality, safe, effective and affordable epoetin alfa to patients, physicians and payers in the United States.”
Sandoz has marketed biosimilar epoetin alfa in the European Union for five years under the brand name Binocrit. The company said it also is enrolling patients and conducting other phase-2 and phase-3 trials of biosimilar versions of Roche’s Rituxan (rituximab) and Amgen’s Neupogen (filgrastim) and Neulasta (pegfilgrastim).
The Patient Protection and Affordable Care Act of 2010 included an amendment mandating a regulatory approval pathway for biosimilars, though the regulations have yet to be completed and put into place. Until that happens, companies looking to manufacture and market biosimilars for the United States market must still go through the same approval process that the Food and Drug Administration uses for brand-name biotech drugs.
Vast majority of online pharmacies are fly-by-night operations, report finds
MOUNT PROSPECT, Ill. — About 97% of online pharmacies are "rogue" operations operating outside U.S. laws and regulations, according to a new report.
The National Association of Boards of Pharmacy issued its report, “Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: October 2012,” for which it analyzed more than 10,000 sites, finding 97% of them to operate “out of compliance with pharmacy laws and practice standards in the United States.” The report concluded that it was important for members of the international pharmacy community to protect patients worldwide from the potential dangers of illegal online drug sellers, noting that the illegal sites provide a way to sell counterfeit drugs.
Of the sites reviewed, 9,543 appeared to be affiliated with networks that obtain drugs from “questionable sources”; 4,832 offer drugs that are foreign or not approved by the Food and Drug Administration; 8,594 don’t require valid prescriptions; 2,274 have physical addresses outside the United States, while most rogue sites post no address; and 3,708 are hosted on servers outside the United States.
The report gave an overview of recent collaborative efforts, including a 100-country Operation Pangea, which resulted in the shutdown of thousands of sites; an investigation by LegitScript.com, which gave the NABP and other organizations evidence that led to the shutdown of about 5,000 rogue sites; and a collaboration with Canadian regulators to extend the Verified Internet Pharmacy Practice Sites accreditation program to include Canadian websites selling drugs approved by Health Canada, that country’s counterpart to the U.S. FDA; and a meeting with officials from China’s State Food and Drug Administration to discuss prescription drug regulation, especially as it relates to the Internet.
Catamaran programs win awards
LISLE, Ill. – A pharmacy benefit manager has received two awards for what it called "innovative healthcare tools."
Catamaran Corp. announced that it was named a 2012 Chicago Innovation Awards Top Ten Winner for its Enhanced Coordination of Benefits program, which identifies the payer of a claim while addressing quality of care and delivery of benefits for patients. It also received the Silver Honors for Healthcare Consumer Empowerment and Protection from healthcare accreditation organization URAC for its Real-Time Solutions to Collaborate and Improve Adherence initiative, which it developed with the University of Toledo.
“Catamaran’s Enhanced Coordination of Benefits program is the only offering on the market that is performed proactively rather than after a claim is processed and paid, saving dollars, resources and time,” Catamaran EVP research and innovation John Romza said. “It is just one example of our passion for creating leading-edge programs that save money and pave the way for a healthier, more productive society.”