FDA to issue multiple biosimilars guidances

FDA plans to issue multiple guidance documents on biosimilars, including one to be released "by the end of the year," the agency's Rachel Behrman said in an interview that will be broadcast Sunday on BioCentury This Week, BioCentury's public affairs television program. Behrman, associate director for medical policy in FDA's Center for Drug Evaluation and Research, said the agency intends to tell potential biosimilars manufacturers what the "standards will be in terms of establishing biosimilarity."

Behrman also said that while FDA is learning from European experience with biosimilars, "what I think we've shown in our decision on generic enoxaparin, is we may be able to take the European experience and go one step further." FDA approved Momenta's generic version of Lovenox enoxaparin from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) in July 2010 without requiring any clinical data. Heparin products, including enoxaparin, are regulated as drugs in the U.S. but are considered biologics by the EMA. An EMA guideline released in 2009 requires clinical data to approve biosimilar versions of low molecular weight heparin products like enoxaparin. ...