The Emerging Role of Biosimilars

Countries around the world face a growing, aging population and an increase in chronic disease. With expanding demand for good-quality healthcare comes the challenge of controlling healthcare expenditure.
The safe and regulated introduction of biosimilars into the market has been forecasted to increase access to much needed biologic medicines and reduce costs.

Over the next few years, a new generation of complex biosimilars will be developed as numerous leading biologic medicines, worth an estimated $81 billion in global annual sales, will lose their patents by 2020. Fusion proteins and monoclonal antibodies used in cancer and autoimmune diseases are expected to form a substantial proportion of this new line of biosimilars.


The European Medicines Agency (EMA) is updating its guidelines on biosimilars to include these new biosimilars and has produced separate guidance for specific therapy classes, including monoclonal antibodies.The biologic medicines market is expected to grow to $190-200 billion by 2015, with biosimilars a small but growing proportion at $2-2.5 billion. [Ref: Amgen Inc]