Abstract

BIOSIMILARS: REGULATIONS AND EMERGING MARKET NEEDS

Karri Siva Durga* and M. Swapna

ABSTRACT

Biosimilars are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated similarity to innovator biologic products in terms of quality, safety and efficacy. Generics are the small-molecule pharmaceuticals that are developed and produced relatively straightforward with the reference product. These made regulatory and administrators of different countries to establish strict balance between the cost benefit and risk management of the product. The first draft guideline for Biosimilars was established by Europe, subsequently Japan and USA has developed the draft guidelines. While recently India has established the biosimilars guideline in June 2012. India has vigorous Pharmaceutical Industry for the generic drug while it can become an emerging market for the Biopharmaceutical drug. The regulatory structure for the biosimilars in India is depicted in this article with comparison of the biosimilars guidelines established by India and WHO. The approval process will be based authenticating a comparability quality between the biosimilars products and original productThe scope of this project lies with the Regulatory requirements for the approval process of Biosimilar in Regulated & Emerging Markets. It gives basic requirements that are required in Product life cycle which initiates from Research laboratory stage to Post market surveillance. Most countries either use or amend their existing legislation and applicable regulations or develop entirely novel regulatory frame works for the authorization of biosimilars.

Keywords: Biosimilar, Post market surveillance, generic drugs, regulatory requirements.