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THE PHARMA REVIEW (MAY – JUNE 2016)

BIOBETTERS: May Be a Better Bet

Balamuralidhara V., Shankargowda R Patil, T.M. Pramod Kumar & Suraj P.S

Introduction: Biobetter are the new molecules which are required to improve disposition, safety, efficacy, or manufacturing attribute and produces the same effects as that of original drug which is related to existing biologics. Biobetter are the improved version of the biosimilars. The dispassionate of this Biobetter’s is that it provides the same effect that of the original biosimilar drug at reduced price, with reduced side-effect profile, efficacy of the originator biologic and validated target. Biobetters are considered as biologic generics and these are the rising regulatory issues that they cannot be same as generics of new chemical drugs. Regulators are demanding more proof in terms of clinical equivalence, safety and efficacy. In choosing the pre-clinical development of biobetters an investor would always prefer to go for Biobetter as the scope of filing a new patent and charging more price than the originator biologic. This article gives about the importance of biobetters over the biosimilar, unlike the biosimilars there is no abbreviated regulatory route for biobetter. 

 

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