Regulatory frame work for biosimilar monoclonal antibodies

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

K. Sreekanth Reddy

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

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.

Biography :

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.