156 страниц. 2013 год. LAP Lambert Academic Publishing Biosimilars have been a buzz word in pharmaceutical industry now-a-days due to melting of generic products and growth of biological in terms of market capture and efficiency. Also the biological products are more technology driven than the chemical products. Due to more novelty and technology there is a strong need of biosimilar regulations. Keeping in view to this, most of all the regulatory authorities have formed the biosimilar regulations leaded by US FDA and followed by INDIAN, Canadian, Japanese, Chinese, Korean and Singapore regulatory authorities. The stringent of all are USFDA regulations followed by Health Canada.