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Makers of protein-based biologics approved under the NDA pathway will lose all exclusivity rights in four years, and any NDA or ANDA that hasn’t been approved by March 23, 2020, will be voided. Read More
An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support in February, backing its approval for six different indications. Read More
Teva Pharmaceuticals scored FDA approval for its generic of the blockbuster erectile dysfunction drug Viagra, but it won’t be commercially available anytime soon. Read More
Comments to the European Commission on proposed changes to orphan drug policy show much agreement on the need for change, but little agreement on how to make those changes. Read More
Notification requirements under the federal biosimilars law are getting renewed attention with two recent court filings: one, a petition to the U.S. Supreme Court, and the other an amicus brief before the U.S. Court of Appeals for the Federal Circuit. Read More