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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pharmacogenomics subsections to their prescription drug and biologic product labels when necessary, according to FDA draft guidance released Wednesday.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
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts about the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
AstraZeneca is suing India-based generics firm Zydus Cadila to block its bid for a version of the brand manufacturer’s acid-reflux drug Nexium. Read More
New Jersey-based Mutual Pharmaceutical and two other generics firms are suing brand manufacturer Reckitt Benckisser for breach of contract, alleging that RB reneged on a license agreement to provide generic supplies of its cold and flu medicine Mucinex for sale. Read More
Boehringer Ingelheim is suing Amneal Pharmaceuticals over its bid to make a generic version of the brand manufacturer’s anti-stroke drug Aggrenox. Read More
A group of brand and generic drugmakers has asked a federal judge to toss out a multidistrict class action lawsuit accusing them of colluding to delay generic versions of the painkiller Lidoderm, arguing that a patent infringement settlement between the parties was anything but anticompetitive. 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