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The FDA’s newly created four-point sliding scale of comparability between original biologic products and their biosimilars does not belong in guidance on data to demonstrate that similarity, PhRMA says. Read More
Drugmakers should add microbiology and pharmacogenomics subsections to their prescription drug and biologic product labels when necessary, according to FDA draft guidance released Wednesday. Read More
Two industry groups in India are suing the country’s drug regulatory authority for enacting price controls on scores of branded generic drugs to treat diabetes and cardiovascular disorders. Read More
Generics manufacturer Akorn must sell its rights to a pending ANDA for the tuberculosis drug rifampin before it can complete its $324 million acquisition of VersaPharm, the Federal Trade Commission said. Read More
The FDA will grant marketing exclusivity only to biologics that are fundamentally different from existing products, according to new guidance that explains what manufacturers must do to lock in protection from biosmiliar competition. Read More
Countries in the Caribbean are working to establish a unified registration process for generic drugs, an effort aimed to improve the quality, availability and access to essential therapies. Read More
The U.S. biotechnology industry has endorsed a recent World Health Organization proposal to give biosimilar products a unique name qualifier that distinguishes them from the reference products’ nonproprietary name, a proposal that may run counter to naming protocols in the generic drug industry. Read More
Manufacturers of new drugs, biologics and biosimilars will pay slightly more in user fees this fall for their applications, facilities and products. Read More
The FDA expects to collect $312.2 million in generic drug user fees next fiscal year, with companies paying slightly less for each ANDA filing and facilities that produce active pharmaceutical ingredients and finished generic products paying more. Read More
Generics manufacturers seeking product approvals in the European Union can opt to share the resulting application reviews with regulatory bodies outside the bloc under a pilot program designed to coordinate drug approvals across international borders. Read More
Complaints of particulates found in vials of nine lots of Cubist Pharmaceuticals’ anti-infective drug Cubicin prompted the company to initiate its second recall of the drug in as many days. Read More