Biosimilar

The drug industry has been using this word for several years, but it is only now beginning to appear more widely, in part as a result of the recent approval of the first drug of its type by the European Commission, as well as through attempts to create a regulatory framework for them in the US Congress.

A class of drugs that has become available in the past two decades is made by biotechnological processes using living materials such as proteins and enzymes, often genetically engineered and grown in cell cultures. The industry calls them biopharmaceuticals, biologics, and biotechnology drugs.

Biosimilars are generic, non-proprietary, versions of such drugs. Another name for them is generic biologics. They include insulin, interferon and human growth hormone. Interest in them is growing because patents on the first generation of biologics are expiring.

A complication is that because they’re made using living processes, biologics vary somewhat in nature and effectiveness from batch to batch and they need to be tested in a different way to drugs that have been created by non-living “conventional” chemical processes. Biosimilars are closely related to the branded drugs that they’re designed to replace but they’re not necessarily identical — hence the name.

U.S. Rep. Henry A. Waxman (D., Calif.) plans to introduce legislation in the current session of Congress this fall to create a regulatory framework to approve “biosimilar,” or generic biologic drugs.

Philadelphia Inquirer, 19 Sep. 2006

Generics companies are also keen to get into this area, and have started to branch out into biosimilars — generic versions of biotech drugs.

Guardian, 26 Sep. 2006