The labeling for biosimilars should rely largely on the relevant safety and effectiveness data used by the corresponding US-licensed innovator medicines, with appropriate product-specific modifications, the FDA said in a new long-awaited draft guidance document issued on March 31 – declaring that's the best approach the agency could come up with after six years of trying.
The major drug industry lobbying groups – the Pharmaceutical Research and Manufacturers of American (PhRMA), the Biotechnology Industry Organization (BIO)...
