AN OVERVIEW OF BIOSIMILARS
Abstract
Biosimilars are surmounting pharmaceutical market from last three decades and sale increasing progressively. Advances in the biotechnology
lead to development and discovery of new biological products to treat various life-threatening diseases. Biosimilars are biological drugs that are
produced after expiry of the patent of approved innovator. This review attempt to highlight the differences between biosimilars and chemical generics,
development stages, issues of concern with the use of biosimilars and need of appropriate regulations for their approval. Generic approach is not
scientifically useful to manufacture biosimilars. Biosimilars have more structural complexity, multi-layered manufacturing or scale-up process and
risk of immunogenicity; therefore required unique regulatory pathways to introduce them in the market. Safety and efficacy of biosimilar are essential
parameter to increase access in the population. Biosimilars can ensure the cost-effective treatment to invade incurable diseases due to enhanced
competition in pharma/biotech industries to manufacture it.
Keywords: Biosimilars, Biologics, Follow-on biologics, Generic drugs, Subsequent-entry biologics.
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