International Journal of Drug Development and Research

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3. Biogenerics-need for Regulatory development in India

Palleti Lakshmi Prathusha N. Vishal Gupta

First-generation biopharmaceuticals have come off patent or lose marketing exclusivity. This has paved the way for the manufacture of generic biopharmaceuticals which are otherwise called as biogenerics. According to estimation, biologic drugs worth more than $80 billion in global sales will lose patent protection by the year 2015, presenting a major opportunity for biogenerics. Biologic-based drugs are expected to push the contract manufacturing industry for growth and development over the next few years. Already India is enjoying a significant growth in the biogenerics manufacturing sector. But some of the significant obstacles with respect to regulations and their compliance with other countries must be considered. The main aim of the article is to demonstrate an immediate need for regulatory development of biogenerics in India. Since the market size for biogenerics is highly appreciable and has breaked the barriers of historically restricted usage due to highly costly biologicals. They are becoming technologically feasible and financially necessary, therefore are gaining regulatory and political attention. Indian companies can establish expertise in biogenerics, which can then be transferred to more established pharmaceutical markets. Hence in order to make India as a leading contributor for biogenerics, a clear regulatory pathway is required to meet foreign standards. This will sufficiently provide an opportunity to India to compete with countries like America and Europe in terms of regulatory aspects of biogenerics.