Mylan Launches Generic Cancer Therapy Treatment
By Lori Clapper
Mylan announced Monday that it launched Capecitabine Tablets, its generic version of Genentech's Xeloda. The U.S. Food and Drug Administration (FDA) gave its final approval for Mylan’s Abbreviated New Drug Application (ANDA) for this product, which can to be taken as a monotherapy, adjuvant, or combination therapy for certain types of breast, colon, and colorectal cancers, the company said in an announcement.
"The approval of this product, one of a number of key approvals that had been pending with FDA, adds an important product to our broad and growing oncology franchise,” CEO Heather Bresch commented. “We look forward to bringing a lower cost generic version of this product to patients."
Capecitabine is the latest in string of approvals in the past two months. In July, the company announced the launch of its Telmisartan tablets, the generic version of Boehringer Ingelheim's Micardis Tablets to treat hypertension. Similarly, its ANDA for Risedronate Sodium, the generic version of Warner Chilcott's osteoporosis Actonel Tablets, was approved in June.
Mylan has 296 ANDAs pending FDA approval, which represent $106 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities.
These successes are good news for both Mylan’s generics business and patients, in light of findings from a study released last month by the Generic Pharmaceutical Association (GPhA). The research document, Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry, found that ongoing abuse of FDA drug safety programs by brand-name drugmakers not only prevents generic competition, but costs the American health care system and patients $5.4 billion in pharmaceutical spending each year. It’s money that could be saved if just 40 generic drugs that were examined in the report were permitted to come to market.
When REMS and “Restricted Access Drug” programs are used, generic drug firms are denied access to samples of brand drug products, making it impossible to conduct appropriate testing and secure subsequent approval of generic medicines. Refusing access to samples effectively delays generic alternatives for patients, and extends brand product monopolies.