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A federal judge has ruled that the FDA was right in approving generic versions of Otsuka’s blockbuster antipsychotic Abilify, despite exclusivity remaining on at least one indication, removing any final obstacles to market entry of those drugs Read More
Three years after introducing a trio of guidances explaining how sponsors must demonstrate biosimilarity to existing biological drugs, the FDA continues to stress the need for a “stepwise” approach when seeking approval. Read More
The California Supreme Court on May 7held that a pay-to-delay agreement between Bayer and Barr Laboratories over a generic of the brandmaker’s antibiotic Cipro violates the state antitrust law. Read More
Tennessee has joined a growing list of 11 states to pass legislation enabling pharmacists to substitute a biosimilar for a branded biological product, in a move applauded by industry. Read More
A federal appeals court has granted a temporary injunction barring Sandoz from marketing its biosimilar of Amgen’s blockbuster chemotherapy drug Neupogen. Read More
Eleven pharmaceutical and biological medicines companies have joined forces to promote the availability of biosimilar medicines, under the aegis of a new Biosimilars Forum. Read More
The FDA increased its generic preapproval inspections by 60 percent between FY 2011 and 2013, but didn’t conduct all those requested by agency reviewers. Read More