Abstract - 2015 Volume.6 Issue.1

The prospect and feasibility behind this kind of attention towards biotechnology and biosimilars is due to its boundless prospectus to serve mankind. So far, biotechnology has touched our lives in all directions, such as, health, food and animal life. It is also essential to notice the importance and potential of biotechnology for the improvement of our environment and for better living. We also retire for the day with bedside medicines either to keep us healthy or to control chronic diseases, like stroke, arthritis, diabetes, which makes our life better. So, a strict regulation is required for the biotechnology products and biosimilars in any country because of its safety and efficacy issues. These are mostly used medicines these days and it is also concluded that many patents for biotechnology has either been expired or ready to expire in the current era. Also the innovator drugs are costly, so regulation of biosimilars has become the necessity. So, the regulation, registration, documents for biosimilars, Aseptic process, labeling requirements, ADR reporting system for biosimilars are some important regulatory parameters which are focused in the article.

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