REGULATORY APPROVAL OF BIOSIMILARS: INDIAN MARKET PERSPECTIVE

Biologics, considered as one of the fastest growing sectors of the pharmaceutical industry, has introduced many new treatments to life-threatening and rare illnesses. A majority of biological products, which currently generate high revenue, are set to lose patent protection during the period 2015-2020, providing the biosimilar players with an opportunity to enter global market and yield high revenues. The choice of India as one of the destination for the market of the biosimilars is that India is considered as leading emerging market for biosimilars & Indian companies have huge domestic markets and low cost manufacturing models and ensures the manufacturer a good market value. In India, CDSCO (Ministry of Health and Family Welfare) and Dept. of biotechnology (Ministry of Science and Technology) regulates the marketing authorization of biosimilars. The boom of companies in the future Biosimilars market depends on the alignment of pharma cycles like manufacturing, clinical evaluation, commercialization and regulatory guidelines in a single strategic framework, which results in not only local market dominance, but a significant global presence. Many emerging nations like India are establishing biosimilars regulatory pathways, giving sponsors opportunities to select research sites strategically to optimize overall development timelines and achieve registration goals.