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Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance. Read More
India’s patent office has sided with a challenge from generics maker Cipla and struck down a patent protecting Boehringer Ingleheim’s blockbuster COPD drug Spiriva. Read More
Brand and generic drugmakers want the FDA to take responsibility for safety labeling changes to all drugs with at least one generic equivalent and scrap its proposed rule to give generics firms the ability to update label safety information independently. Read More
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