Regulatory framework for Biosimilar Approval Process in the - IPCA

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Dec 12, 2012 (4 years and 8 months ago)

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REGULATORY FRAME
WORK FOR BIOSIMILAR APPROVAL PROCESS IN THE
US WITH A

PERSPECTIVE TO INDIAN PHARMA INDUSTRY

YOGESH GUJAR, ABHILASH MADHAVNENI,
SUDHEER MOORKOTH,
ADREEJA
BASU
, PRAVEEN KADWEY

Department of Drug Regulatory Affairs, MCOPS, Manipal University,

Manipal


Abstract

Biogenerics or follow
-
on biologics are terms used to describe officially approved version of an
already existing innovator drug (whose patent has expired) by a different sponsor.

Since
biosimilars have larger molecular size compared to their chemically
-
synthesized counterparts the
regulations for biosimilars are more stringent.
Until 2009 there was no abbreviated approval
pathway for biologics licensed under section 351 of PHSA. T
he patent protection and affordable
care act (health care bill) of 2009 signed into law on March 23, 2010 establishes a truncated
pathway. The pathway is called Biologics Price Competition and Innovation Act (Biosimilar
Act), and approval is under 351(k).

In India biosimilars regulations are framed as per the Drugs
and Cosmetics Act 1
940, the CDSCO, DCGI under the Ministry of Health and Family Welfare
have been responsible for approvals. For biologics, additional approval required by other
agencies, includi
ng Genetic Engineering Approval Council (GEAC), Review Committee on
Genetic Manipulation (RCGM) etc. Even though there are similarities between the Biosimilar
Act and the Hatch Waxman Act, there are much more differences. Unlike regulation provided for
gen
eric pharmaceuticals biosimilar regulation are not much promising for Indian industries
mainly because of it unclear guidelines. The extent of biosimilar entry into the health care market
still remains open to speculation. In this study, the streamlined pr
ogress of biogenerics in India
and a comparison of regulations in India and USA are been described.