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The objective of this paper is to facilitate regulatory requirements for the approval process of Biosimilar Monoclonal antibodies
(mAb) in Regulated and Emerging markets. Biosimilars are biological products that are the replicas of their innovator
biopharmaceuticals. Monoclonal antibodies have been established as a major product class of biotechnology-derived medicinal
products. Specified regulations, and approval process of generic version of mAb exists depending on the country. In European
Union, Centralized Procedure is mandatory for Biosimilar (mAb). When compared with other countries EMA (European
medicines agency) has proper regulations pertaining to Biosimilar mAbs. In US proper set of guidelines for Biosimilar (mAb) have
evolved after ?Promoting Innovation and Access to life-saving Medicines Act? introduced, authorized USFDA to approve followon
biologics/biosimilars in an abbreviated manner. The approval process is abbreviated biosimilar biologics license applications
(bBLAs) or 351(k) filings. In India, the product is under new drugs, and follows the Biological drugs submission requirements.
In India, apart from Central Drugs Standard Control Organization (CDSCO), the office of Drug Controller General of India
(DCGI) the apex regulatory body under Government of India (GoI), two other competent authorities are involved in the approval
process of biosimilars or Similar Biologics products (SBPs). It is a big difficulty to Biosimilar mAb potential producers to fallow
different approval processes and regulations in different regions. This paper concludes that there is a need that ICH/WHO should
come forward and lay down proper and specific regulations for these products.
I K.Sreekanth Reddy, studying m.ph first year regulatory affairs in jsscp, Mysore. I completed my B.ph at Victoria College of pharmacy, Guntur .I
given poster presentation on 63rd IPC held at Bangalore.
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