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Biosimilars makers are not required to share their applications and manufacturing processes with the biologics company whose product they are copying, the FDA says, rejecting Amgen’s argument that the law that created the biosimilars pathway mandates disclosure of that information. Read More
Consumer and patient advocacy groups made their case for the FDA’s proposed rule to give labeling parity to generic makers, one day ahead of an FDA public hearing to again solicit comment on the plan. Read More
The FDA continues to look into improving generic bioequivalence testing, sponsoring research into BE evaluation of drugs for which doctors are most likely to resist substituting a generic, such as anticoagulants. Read More
European regulators are establishing a task force that will advise on planning, developing, implementing and maintaining international standards on drug product identification. Read More
Drugmakers seeking approval of genetically engineered products must begin submitting an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More
Drugmakers may use pharmacokinetic bioequivalence studies to compare how two orally-inhaled drugs with the same active substance disperse in the lungs, the European Medicines Agency says. Read More