ABSTRACT

Biologics are the fastest growing segment of the pharmaceutical industry, offering innovative treatment for life threatening diseases. High costs make the treatment inaccessible to most patients. This, coupled with many biologics going off patent, have triggered interest in the affordable analogues of innovator termed as biosimilars. Since these are not replicas of the innovator, they pose grave challenges to the biosimilar manufacturer. Moreover, biosimilar manufacturer has to comply with stringent regulatory requirement laid down by the health authorities of respective countries to ensure safety and efficacy.