FDA biological comparability policy may spur generic biologic industry growth -- Fenwick & West's Mackler.

Executive Summary

FDA COMPARABILITY POLICY MAY FACILITATE GENERIC BIOLOGICS, Bruce Mackler, PhD, a partner in the Washington, D.C. law firm Fenwick & West, suggested at the Jan. 7 BioEast meeting in Washington, D.C. Under FDA comparability guidelines that allow analytical testing and other assays to substitute for clinical trials, biotech "companies are now encouraged to incorporate new technology very rapidly into the manufacturing process to increase productivity [and] reduce costs," Mackler said. The next step, he said, "is the concept of equivalent biologics, or comparable biologics as generics."