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.
|Number of pages||5|
|Journal||Asian Journal of Pharmaceutical and Clinical Research|
|Publication status||Published - 01-01-2015|
All Science Journal Classification (ASJC) codes
- Pharmaceutical Science
- Pharmacology (medical)