The Intelligence Study Of Regulatory Issues On The Biogenerics

With a clutch of first-generation biologicals approaching patent expiry, the potential for biogenerics appears great. But in reality biogenerics face an uncertain future. Much of this uncertainty is down to their unusual regulatory position. As biopharmaceuticals are defined by their production process, any change can impact safety and efficacy and therefore demands new approval. In effect, it is impossible to replicate the biological process exactly, which makes it difficult to prove essential similarity, or equivalence.The thesis is the first systematic study concerning the key regulatory issues surrounding approval of biogenerics in China. On the basis of comprehensive utilization of multiple methods for intelligence analysis, including literature retrieval, integrated induction, systematic analysis, analogy analysis, typical case study and expert consultation, the author inductively summarized the developments in the regulatory environment for biogenerics in the US, EU and China, and understood the key regulatory issues surrounding approval of biogenerics.In the EU, the European Commission led the way by creating a legal framework for biogenerics in 2003. The EMEA had therefore been able to move forward and had already published several draft guidelines, including specific clinical and non-clinical data requirements for four product types: insulin, human growth factor, epoetin and CSFs. And in April 2006, the European Commission granted marketing authorization for the Sandoz's recombinant human growth hormone Omnitrope~?.The US is notably lagging behind the EU, with branded opposition exerting a much greater influence and slowing down regulatory reform. US Congress has yet to create legislation for biogenerics, although this could change soon. The FDA has been unwilling to use the controversial 505(b)(2) pathway to approve 'generic' versions of...