BIO calls for different names for biosimilars, branded biotech drugs
NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.
Like their pharmaceutical counterparts, branded biotech drugs carry both a brand name and a generic chemical name, such as the autoimmune drug Enbrel, made by Amgen and Pfizer, known generically as etanercept. By law, generic pharmaceutical drugs are chemically identical to branded drugs and use the same generic names, and the companies wishing to make follow-on biologics, or biosimilars, want the same policy for their products.
But biotech companies say that because biosimilars are made from different cell lines from branded biologics, they are only similar rather than identical, and thus their generic names should be different, such as carrying a prefix.
Last week, six senators submitted a letter to Food and Drug Administration commissioner Margaret Hamburg expressing concerns over biosimilar naming, and the Biotechnology Industry Organization, a trade group representing biotech companies — which stand to lose billions in sales when biosimilars begin hitting the market and competing with their products — has said it "strongly opposes" using the same generic names for biosimilars and branded biologics, saying it will lead to confusion.
"Use of the same nonproprietary name suggests something that is not true for biosimilars — that they are the same as the innovator drugs they reference," a recent statement from BIO read. "When ultimately approved by the FDA, biosimilars will be similar to, but not the same as, their respective reference products."
By contrast, generic drug companies and their supporters say biosimilars and branded biologics have used the same generic names in Europe during the six years they have been available there, without any problems.
Actavis seeks approval for generic acne drug
DUBLIN — Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.
The drug maker announced that it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Acanya (clindamycin phosphate; benzoyl peroxide) gel in the 1.2%/2.5% strength. Acanya is made by Valeant Pharmaceuticals International and Dow Pharmaceutical Sciences and is used to treat acne vulgaris in patients aged 12 and older.
The filing contained a paragraph IV certification, a legal challenge to a patent on the drug, triggering a lawsuit against Actavis that Dow and Valeant filed in the U.S. District Court for the District of New Jersey last week. Under the Hatch-Waxman Act of 1984, the lawsuit places a 30-month stay of FDA approval on Actavis’ product, unless the companies settle the case. As the first company to successfully file for FDA approval, Actavis would be entitled to 180 days of market exclusivity in which to market the direct in direct competition against the branded version.
Acanya had sales of $62 million during the 12-month period that ended in July, according to IMS Health.
FDA introduces e-learning program about untruthful, misleading drug ads
SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.
The FDA’s Office of Prescription Drug Promotion announced Monday the launch, with MedScape, of the e-learning course, which offers continuing education credits for healthcare professionals. The course is part of Bad Ad, a program designed in 2010 to raise awareness about misleading and untruthful drug ads. It’s aimed at healthcare professionals, but anyone can take it, the agency said. The office has developed several case studies based on warning letters the FDA has sent to drug companies, representing common problems.
"We encourage medical, pharmacy, nursing and other healthcare-related schools to incorporate these cases into their coursework," Office of Prescription Drug Promotion director Thomas Abrams wrote in a blog entry on the FDA’s website. "The cases cover a range of promotional materials including a website, journal ad and TV ad, and touch upon numerous promotional practices that don’t comply with our regulations."