Will Biosimilars Lead To Better Biologics Manufacturing?
US FDA Commissioner Gottlieb is promising new policies to improve biologics manufacturing as part of agency’s action plan to accelerate biosimilar development. That follows the pattern set 25 years ago with generic drugs and brand manufacturing.
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The US FDA commissioner called recent initiatives to get drug rebates to patients at point-of-sale "healthy" public policy, and suggested insurance premiums have been subsidized by sick patients, addressing CNBC's health care conference.
WARNER-LAMBERT FAJARDO, P.R. PLANT TO BE TAKEN OFF FDA INTEGRITY POLICY SOON, FIRM SAYS; FAILURE TO REPORT DILANTIN TEST FAILURES PROMPTS GUILTY PLEA
Warner-Lambert's Fajardo, P.R. plant will be cleared under FDA's application integrity policy in the near future, the company said following its guilty plea in a case stemming from failure to report stability failures of drugs, some of which were manufactured in the plant.
As it announced the formal European Commission approval of its partnered Polpharma Biologics-developed Tyruko natalizumab biosimilar to Tysabri, Sandoz offered Generics Bulletin a timeframe for its expected launch in Europe.