Abstract
Patents for several biologic blockbusters will expire in the next few years. The arrival of biosimilars, the biologic equivalent of chemical generics, will have an impact on the current biopharmaceuticals market. Five core capabilities have been identified as paramount for those companies aiming to enter the biosimilars market: research and development, manufacturing, supporting activities, marketing, and lobbying. Understanding the importance of each of these capabilities will be key to maximising the value generated from the biologics patent cliff.
Highlights
The term patent cliff refers to an abrupt drop in sales of a group of blockbuster (A blockbuster is defined as a medicine that exceeds global sales of 1 billion USD per annum [1].) products after reaching the end of their patent life
It is expected that the price drop for biosimilars will not be as pronounced as for generics, because companies entering the market need to overcome these barriers yet still make a financial return
The market value captured by these companies is under threat due to the imminent biologics patent cliff
Summary
The term patent cliff refers to an abrupt drop in sales of a group of blockbuster (A blockbuster is defined as a medicine that exceeds global sales of 1 billion USD per annum [1].) products after reaching the end of their patent life. Plavix, Singulair, Diovan and Lipitor are all chemical blockbuster drugs discovered in the 1990s, with patent expiration date falling between 2011 and 2015. The revenue obtained through the sales of these products is at risk of falling drastically within these years, contributing to the so-called chemical drug patent cliff. A decrease in global sales follows after the Pharmaceuticals 2012, 5 year of patent expiration. This is already evident for Effexor and Lipitor, and the same trend is expected for Plavix. The shadowed areas correspond to the patent expiration year as indicated in the legend (data from: [2,3])
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