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The FDA Thursday released long-awaited draft guidance on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix. Read More
Just days before Sandoz is expected to launch Zarxio, its biosimilar of Amgen’s chemotherapy drug Neupogen, the FDA issued a proposed rule changing both drugs’ official names, at least temporarily. Read More
Mylan scored a potential win from the U.S. Patent and Trademark Office when it agreed to review challenges to two patents on Teva’s blockbuster multiple schlerosis drug Copaxone. Read More
Biologics makers developing drugs based on bacteria and viruses should conduct preclinical and clinical studies to determine if infection could be unintentionally transmitted from treated patients to other individuals, the FDA says. Read More
The FDA submitted Designation of Official Names and Proper Names for Certain Biological Products as a proposed rule to the Office of Management and Budget on Friday, but would not comment on whether it is the expected guidance on naming biosimilars. Read More
A drug pricing watchdog was rebuffed Monday in its attempt to get the U.S. Patent and Trademark Office to review two patents on Acorda Therapeutics’ blockbuster multiple sclerosis drug Ampyra — the first of 18 petitions the Coalition for Affordable Drugs has filed with the agency since February. Read More
The FDA appears to have anticipated one issue drugmakers raised at a Monday public meeting on its quality metrics draft guidance — extending the comment period on the document until Nov. 27. Read More
The agency wants to improve nomenclature following complaints by generic drug and excipient makers that the current format delays ANDA filings. Read More
Industry questioned whether the FDA has the legal authority to enforce its quality metrics guidance during a Monday public meeting on the draft document. Read More