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Generic drugs continued their market growth last year, rising two percentage points to 86 percent of all prescriptions dispensed in the U.S. market, according to a new study. Read More
Boston-based Epirus Biopharmaceuticals has received final approval in India for its biosimilar of the autoimmune therapy Remicade, making it the first biosimilar of the product in that country. Read More
The FDA for the first time has published a reference list for biologics, known as the Purple Book, that will list all brand products and any biosimilars with which they are interchangeable. Read More
New York’s attorney general has filed what may be a first-of-its-kind antitrust lawsuit against Actavis and subsidiary Forest Laboratories for seeking to switch patients on its Alzheimer’s drug Namenda to a newer formulation with longer lasting patents in order to stave off generic competition. Read More
The FDA’s database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, say generics makers who laid out a variety of other shortfalls they see in the agency’s generic drug approval process. Read More
Generic drugmakers submitting ANDAs indicating impurities in proposed products that exceed established thresholds must provide detailed justification to avoid having the application rejected, the FDA said. Read More
The FDA needs to clarify whether its 10-day ANDA correspondence clock starts ticking once a manufacturer receives the agency’s communication or at the moment the agency mails it, say generics firms, which also urge the FDA to start sending all communications by fax or email. Read More
European regulators have approved Eli Lilly and Boehringer Ingelheim’s insulin glargine drug Abasria, a biosimilar version of Sanofi’s blockbuster product Lantus. Read More
The FDA is moving to ease industry fears that ANDAs filed after September of this year will receive priority over earlier applications simply because they were filed before the law required the agency to assign review deadlines to new applications. Read More
The FDA denied Teva its 180-day exclusivity period for a version of Warner Chilcott’s osteoporosis drug Actonel 150 mg because the agency itself didn’t tentatively approve Teva’s ANDA fast enough, according to an internal agency document. Read More
Beleaguered Indian generics maker Wockhardt has initiated a voluntary Class II recall of 11,661 bottles of metoprolol succinate, a generic version of AstraZeneca’s blood pressure drug Toprol-XL. Read More