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The FDA still plans on finalizing the highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More
The FDA has updated its list of planned guidances for the calendar year to include one on evaluating the abuse-deterrent properties of generic solid oral opioid drugs. Read More
Two state legislatures are considering biosimilar substitution bills, but are taking opposite approaches to the issues of prescriber notification and patient consent. Read More
The FDA will hold a June 5 public hearing at its White Oak, Md., campus to discuss FY 2016 regulatory science research priorities for generic drugs. Read More
Republican lawmakers warned the FDA March 4 to expect fiscal year 2016 funding levels to be in line with this year’s $4.4 billion, not the full $4.9 billion requested. Read More
The FDA March 6 gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
A federal appeals court issued an injunction halting sales of Actavis’ generic version of AstraZeneca’s inhaled asthma drug Pulmicort Respules, just four days after the generics maker launched its version. Read More
The FDA has laid out a regulatory research agenda for the year that includes identifying better methods for assessing generics, improving drug safety and biosimilars development, and finding ways to assess advanced, new drugs as areas where the agency would like to sponsor research. Read More
The FDA is pushing ahead with efforts to spur development of hard-to-copy generics, this time sponsoring research into bioequivalence testing for long-acting periodontal drugs and developing methods for assessing generic, long-acting injectables. Read More
South Korea-based Celltrion launched its biosimilar of Janssen’s autoimmune disease therapy Remicade in another 12 European markets, bringing the product’s total presence to 31 countries. Read More