Genentech's shot at biogenerics

Genentech Inc. has renewed the biotech industry's efforts to preempt FDA's creation of a pathway for the approval of biogenerics. The latest anti-biogenerics initiative comes after the departure of Mark McClellan, who had asserted the agency's authority to approve generic versions of biologic products that are regulated as drugs.

McClellan unambiguously stated that FDA has the authority under section 505(b)(2) of the Food, Drug and Cosmetic Act to approve generic versions of human growth hormone and insulin. He also said that it was good public policy to do so because generic competition would lower healthcare costs. ...