Patent search on biologics as potential biosimilar candidates

The biological pharmaceutical market is one of the fastest growing sectors in the health care business. Sales of biologic drugs reached $120 billion in 2008 [1] and the worldwide market of biologics continues to grow (IMS Health). As patents on first generation of biologic drugs, including epoetin, insulin granulocyte colony-stimulating factor (G-CSF) and interferon alpha, will soon expire, if they have not already, and patents on some of the second generation of biological drugs, such as antibody drugs, are going to be expire in the next few years, there exists a great opportunity in developing biosimilars, especially for large pharmaceutical companies which face great challenges in developing new blockbuster drugs. In the past few years, the United States, Canada, and Japan have debated or passed legislation on biosimilars with active involvement from top pharmaceutical and generic drug companies. The successful leader in this field will be the one that has the foresight and resources to position themselves well to gain in the future. So what are biosimilars? What are the technological differences between biosimilars and small molecule generic drugs? Finally, what are the considerations for biosimilars in terms of patent searching? An example on a biosimilar study is given here.