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A European Medicines Agency working group is recommending revisions to a guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins to account for differences between large complex and small, simple-structured proteins and other critical issues. Read More
Pfizer was dealt a heavy blow Mar. 12 after a judge cleared the way for five generic drugmakers to begin making generic versions of Pfizer’s blockbuster osteoarthritis drug Celebrex. Read More
Unlike in the EU, Swiss regulators will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved in Switzerland. Read More
To help improve drug safety and quality, the FDA and other countries’ drug industry regulators are considering forming a global authority dubbed the International Coalition of Medical Regulatory Authorities (ICMRA), Commissioner Margaret Hamburg says. Read More
The EU’s primary biotech lobbying group is pushing back against same-name biosimilars, arguing that physicians would find such a system confusing. Read More
The Centers for Medicare & Medicaid Services (CMS) has backed away from its controversial plan that would have removed protected status for antidepressants and immunosuppressants in formularies under Medicare Part D. Read More
GPhA is putting forward a compromise naming scheme for biosimilars that it hopes will quell the dispute over how to assign international nonproprietary names (INN) to follow-on biologics. Read More
PhRMA is seeking substantial changes to the FDA’s proposed generic drug safety labeling rule, saying the agency should pre-approve all safety labeling changes for drugs with more than one manufacturer. Read More
FDA plans to crack down on generic drugmakers initiating patent litigation early by sending premature Paragraph IV certification notices to innovators, though it’s not yet clear what actions the agency intends to take. Read More