ABSTRACT
Bio therapeutic product tends to similar properties like- efficacy, Safety and qualityto a licensed bio- originator. USFDA guideline clearly said that Bio-Similar drugs are not genericmedications nor identical to the innovator medicine and also it’s not ensuring therapeuticequivalence with innovator drug. Getting Bio-Similar product marketing approval is achallenging task. To improve access of Bio-Similar drugs within the US market, US-FDA allowsabbreviated pathway for their approval. Recently India is becoming a most preferabledestination for Bio-Similar manufacturers, because of Make in India program. Introduction ofrecombinant technique to prepare Monoclonal antibody based Bio-Similar drug becomingpopular within pharmaceutical manufactures because of many recent patent expiries ofBiologics. The biologies are produced by cell culture method; hence, chances of variability’s aremore as comparable with the chemically synthesized conventional medicine and variousbiological medicines has led to developed Bio-Similar drugs across the globe. The biologies areproduced by cell culture method; hence, chances of variability’s are more as comparable withthe chemically synthesized conventional medicine. Therefor it is impossible to produce anidentical copy of an innovator product; hence, Bio-Similar is not considered as generic drugs.These drugs are Twin but not a clone of the innovator drug. The Bio-Similar drugs always facechallenges regarding verification of the similarity, the interchange ability, unique naming todifferentiate the various Bio-Pharmaceutical products, commercial opportunities, IPR andpublic safety.
ABSTRACT
OBJECTIVE：To provide reference for summarize the management and clinical use levels of biosimilar products . METHODS：Related policies and regulations about approval and application of biosimilar products were retrieved from domestic and foreign supervision departments and WHO. The biosimilar products were described from multi-dimensional aspects of whole life cycle of drugs ，generic name and prescription ，indication extrapolation ，clinical drug exchange ，pharmacovigilance，medical insurance payment system ，education and training. RESULTS & CONCLUSIONS ：Biosimilar products refer to therapeutic biological products which are similar to the reference drugs which have been approved for marketing in terms of quality ，safety and effectiveness. In R&D ，production，circulation，use and supervision links，the management of biosimilar products has its own characteristics in different countries/areas/organization. In the R&D stage ，biosimilar products do not need to independently verify their safety and effectiveness ，but only step by step use analytical methods to gradually clarify their high similarity with reference drugs in terms of structure and function. The name of biosimilar products in China is the same as that of the original drugs ，and the general name was used in prescription. For FDA to approve the indication extrapolation of biosimilar products ，it needs to be based on the data and information at the time of application ，the safety and effectiveness information of reference drugs ，and the consideration of relevant scientific elements of indications. It needs to be evaluated and used conditionally under supervision. The standard of FDA approval is strict，that is to say ，the approval standard of realizing interchangeability is higher than that of biological similarity which has no such concept in China. The enterprise community ，regulatory agencies ，academic institutions and hospital drug rooms need to communicate and exchange ，and further strengthen post market risk control and safety monitoring. China’s medical insurance department should establish an appropriate payment system and encourage the use of biosimilar products through the payment system. Meclical workers should learn the characteristics of biosimilar products so that they can make good use of biosimilar products in practice on the basis of understanding their technical evaluation.