Registration of similar biological products--Singapore's approach.

摘要

The expiration of patents on many biological medicinal products has prompted the development of these products as similar biological (biosimilar) products. The standard approach of demonstration of bioequivalence for chemical generic products is scientifically not applicable for biosimilar products. The biosimilar product approach, based on comparability (demonstration of similarity), should be adopted. In view of the impending submissions and to facilitate access of such products at a more affordable price in Singapore, the Health Sciences Authority (HSA) formalised the procedures and requirements for registration of biosimilar products in 2009. HSA has published the "Guideline on Registration of Similar Biological Products in Singapore" which describes the basic principles, submission procedure, and requirements pertaining to documentation, pharmacovigilance, and post-approval batch release for the registration of biosimilar products. This article provides a brief overview as well as key points on the registration of medicinal products and biosimilar products in Singapore.