We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
An FDA advisory committee Tuesday voted 12 to 1 to recommend approval of the Vertex Pharmaceuticals Orkambi combination therapy for patients 12 years and older with two copies of the most common cystic fibrosis mutation. Read More