Biosimilar is the term applied to a biological medicine which is similar to another that has already been approved for use. Biological medicines are derived from a biological source such as a bacterium or yeast. They can consist of relatively small molecules such as human insulin or complex molecules such as monoclonal antibodies. Biosimilars are part of a broader family of generic drugs – drugs which are copies of patented drugs but which are authorised for sale after the original drug’s patent expires. Critics of biosimilars argue that they are not the same as the original drug because they do not go through such stringent testing which means they carry more potential safety risks.
biosimilar in the news
In June 2013 European regulators approved the first biosimilar generic versions of a complex biological medicine threatening to dent profits of Big Pharma.
In October 2013 an FT writer pointed out that although it was due to be given approval, Hospira, the company that had been given approval to market the rheumatoid arthritis drug, would have to market directly to doctors and monitor the drug’s use to detect any differences in safety compared with the original. This would mean it would not achieve the same price discount as generic copies of more simple medicines had done in the past.