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Hospira has submitted a BLA for anemia drug Retacrit, a proposed biosimilar to Amgen’s Epogen and Janssen’s Procrit — making it the fourth company to announce submission of a biosimilar application to the FDA. Read More
The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More
In a closely watched case, a federal judge has denied Celgene’s motion to dismiss a lawsuit alleging the brandmaker engaged in anticompetitive conduct by refusing to turn over product samples for ANDA bioequivalence testing. Read More
Indian officials are accusing FDA investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for Indian regulators to tag along on FDA drug manufacturing inspections as observers. Read More
GPhA President and CEO Ralph Neas is stepping down in the fall, the trade group said Tuesday. A search for his replacement will begin immediately, the group added. Read More
Colorado lawmakers have introduced a biosimilar substitution bill that closely mirrors at least one aspect of compromise language unveiled by industry leaders last month — elimination of prescriber notification in favor of entering a switch into an electronic database. Read More
The U.S. Supreme Court Tuesday upheld Teva Pharmaceuticals’ patent on its multiple sclerosis drug Copaxone, overturning an appeals court ruling and preventing Sandoz from launching a generic of the drug. Read More
The European Medicines Agency has extended its pilot program for coordinating international generic drug applications. Under the pilot, drugmakers can make joint submissions through the EU’s centralized procedure and the regulatory authorities of Australia, Canada, Taiwan and Switzerland. Read More