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Abbott Laboratories’ new Barceloneta, Puerto Rico, manufacturing facility will be the primary production facility for TNF inhibitor Humira, the firm announced April 10.
The biologic license application (BLA) for GlaxoSmithKline’s (GSK) cervical cancer vaccine Cervarix includes efficacy data on a wide range of human papillomavirus HPV vaccine strains, including 16, 18, 31 and 45.
Faced with soaring healthcare costs driven in part by biopharmaceutical therapies, federal policymakers should give the FDA power to approve follow-on biologics, AARP said.
Biotechnology industry leaders are telling House lawmakers that proposed legislation allowing the FDA to approve follow-on biologics should include clear and sound patient safety provisions.
House Oversight and Reform Committee Chairman Henry Waxman (D-Calif.) has taken an interest in the debate over how the FDA can approve follow-on biologics, holding a hearing on the issue featuring scientists from the pharmaceutical industry
Recent remarks made by FDA Commissioner Andrew von Eschenbach suggesting that follow-on biologics are not interchangeable with their brand counterparts drew sharp criticism from some generic firms, who view that statement as creating a double standard.
A biogeneric approval mechanism may lead regulators to create separate rules for these types of treatments, according to former U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Mark McClellan, who said he is optimistic that the U.S. Congress will pass legislation this year easing the entry of follow-on biologics.
As the debate over how the FDA should approve follow-on biologics continues, lawmakers acknowledged more work is needed to satisfy certain patient safety and interchangeability concerns raised by the pharmaceutical industry.