Accutane to Face Generic Competition
The risk management program for Accutane was launched this past April in an effort to keep pregnant women from receiving the drug, which can cause serious birth defects and spontaneous abortion.
Developed by Roche with guidance from the Food and Drug Administration (FDA), the risk management program requires that physicians verify their awareness of the adverse events associated with isotretinoin before prescribing the drug. Physicians who agree to abide by strict prescribing rules receive from Roche yellow "Accutane Qualification Stickers" that must be affixed to prescriptions before a pharmacist can fill them.
Genpharm Inc. of Toronto announced on Nov. 11 that FDA had granted marketing approval to the company for Amnesteem, a generic version of Accutane. Amnesteem will be marketed in the United States by a Mylan Laboratories Inc. subsidiary, Bertek Pharmaceuticals, which will also operate a risk management program for the drug product. Amnesteem will be manufactured by Cardinal Health Inc.
Kris King, director of investor relations for Mylan, predicted that Amnseteem will be available shortly after Thanksgiving.
Gary J. Buehler, director of the Office of Generic Drugs at FDA's Center for Drug Evaluation and Research, said that Amnesteem will be prescribed and dispensed under the same restrictions as Accutane.
"There were critical elements identified when the Roche risk management program [for Accutane] was approved," Buehler noted. "These critical elements were made part of the labeling for the product."
Because FDA requires that the labeling for innovator drugs and their generic equivalents be the same, Buehler said, the risk management elements and educational materials for equivalent isotretinoin products must be the same as for Accutane.
As with Accutane, valid prescriptions for Amnesteem must bear a yellow qualification sticker, although Buehler said that the word "isotretinoin" will be used in place of the brand name. Stickers issued by Roche for Accutane will not change, he added.
Buehler said that, despite the specific wording on the stickers, valid prescriptions for one product can be filled with the other if state law allows the substitution.
"The isotretinoin generic is AB rated [equivalent to Accutane], and so that usually allows the product to be substituted," he said.
Carmen A. Catizone, executive director of the National Association of Boards of Pharmacy, said "it's a bit confusing that the stickers are going to be different." But as long "as the generic has been approved, then the pharmacists will know that they can substitute" it for the innovator product.
Catizone urged pharmacists to be certain that each prescription bears a valid sticker before filling a prescription for either product.
Buehler noted that his fellow pharmacists have a critical role to play in educating patients about the risks of isotretinoin products.
"We do hope that pharmacists will emphasize that Amnesteem has the same side effects as the Accutane," he said.
Information about Roche's risk management program for Accutane is available at http://www.rocheusa.com/products/accutane. Risk management information for Amnesteem is not yet available.