Brand Companies Fight Against Calls for Flexible Biosimilars Regulations

Brand-drug makers are putting up a unified front in their efforts to ensure strict limits on the development of biosimilars, telling the FDA that regulation of the drugs should be much tighter than that being sought by generic manufacturers. Speaking at the second day of the FDA’s public meeting on the topic, representatives from brand-drug makers including Johnson & Johnson, Merck and Roche told the agency that policies proposed by generics companies, such as granting approval to multiple indications of a drug that have the same mechanism of action without requiring further testing, would be potentially unsafe.
Washington Drug Letter