Complete Response Letters for generic drug applications have finally taken a dip in 2016. Source: Generic Line

Biopharmaceutical firm Biocad has filed suit against Roche and its Genentech subsidiary over their alleged use of predatory pricing practices in Russia to decimate the sales of the Russian drugmaker’s…

The majority of physicians in the U.S. are familiar with biologics and biosimilars, but many lack the technical knowledge of their structural and therapeutic differences. Source: Generic Line

House members are growing impatient with the FDA over a lack of guidance on biosimilars, with several venting their frustrations during a hearing last month. Source: Generic Line

Notification requirements under the federal biosimilars law are getting renewed attention with two recent court filings: one, a petition to the U.S. Supreme Court, and the other an amicus brief…

An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six different indications. Source: Generic Line

Pay-for-delay deals don’t have to be in cash form for them to be at risk of an antitrust suit, according to a recent federal appellate panel ruling. Source: Generic Line

European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Source: Generic Line

CDER is tightening up its protocols for companies submitting data about active pharmaceutical ingredients used in generic drugs. Source: Generic Line

Democrats and Republicans of the House Oversight Committee took executives of Valeant Pharmaceuticals and Turing Pharmaceuticals to task Feb. 4 over what members called a strategy of buying old drugs…