News: BIO White Paper Addresses the Challenges of Creating Any Pathway for Follow-On Biologics. Genetic Engineering News - Biotechnology from Bench to

News: BIO White Paper Addresses the Challenges of Creating Any Pathway for Follow-On Biologics. Genetic Engineering News - Biotechnology from Bench to Business: "The paper details the legal and regulatory implications of the many important differences between biologics and traditional 'small molecule' drugs. Biologics have very different physical structures and characteristics from small molecule drugs as they are generally large complex molecules produced using living organisms in an intricate manufacturing process. Since traditional drugs and their generic counterparts can typically be shown in a lab to have identical chemical structures, the law and regulations provide a straightforward and safe pathway for the approval of generic versions of drugs. In contrast, a follow-on version of a biologic cannot be a physical duplicate of the innovator version--it can only be comparable or similar. Because of the differences in the complexity of the molecules and the importance of the manufacturing processes used to create biologics, the core scientific principles that allow the Hatch-Waxman Act to provide safe and effective generic small molecule drugs do not apply to biologics."