ABSTRACT:
Biosimilar is a biologic product that is similar to the original innovator product that has been manufactured by a different company.Though, biosimilar and biologics are analogous to each other, biosimilar is the generic version of biologics. Unlike generics where the active ingredients are identical to the reference drug, biosimilar is not identical, rather similar to the reference biologics. Due to post-transcriptional changes, the manufacture of biosimilar is difficult. These complexities that occur in the manufacture of biosimilar make it hard to claim patent. The Patient Protection and Affordable Care Act vindicate the future for granting biosimilars in the U.S through its subtitle, the Biologics Price Competition Innovation Act (BPCIA). 351 (a) application is used for getting approval of new biosimilar while 351 (k) is the biologic license application. For Europe, approval of biosimilars occurs through EMA via centralised procedure. The pilot study can be conducted by the sponsor for scientific advice needed in the filing of biosimilar. The GCC (Gulf Cooperation Council) is an economic and political confederation of six Middle Eastern countries- Kuwait, Oman, Saudi Arabia, UAE (United Arab Emirates), Qatar, Bahrain.Therefore, technically, patent infringement is no big concern as there are no patents for these products in India.