The Biosimilar Opportunity
In 2016 seven of the top ten prescription drugs by revenue are expected to be biotechnology based. Biotechnology drugs with annual revenues of over $20 billion will lose their patent protection in the years 2012-2015.
Biotechnology drugs are often the most effective available treatment for a range of chronic illnesses and medical needs such as forms of cancer and autoimmune diseases.
Governments and payers however face conflicting budgetary pressures and the need to ensure access to first class treatments for their constituents and customers and are welcoming opportunities to provide them with reasonably-priced alternatives such as biosimilars.
Consequently, legislation to enable or encourage direct substitution of biosimilars for originator biotechnology drugs based on INN prescribing is being introduced in a number of countries and regions.
Countries around the globe, including the 27 member states of the EU as a whole, have published detailed draft or final legislation for the registration of biosimilar drugs and are inviting applications for biosimilar medications, from the USA to Brazil and Australia.