Two big biotechnology companies, Amgen and Genentech, are lobbying state legislatures to limit competition to their biological drugs that will lose patent protection in the next several years. Before taking any action, lawmakers should wait for guidance from the Food and Drug Administration, the agency that reviews all drugs and their generic versions for safety and effectiveness.
Biological drugs are made from large molecules, and the processes, involving living cells, are more complex than those used to make conventional drugs. The cheaper competitors to brand-name biological drugs are called “biosimilars” to indicate that they are not exact copies but are close enough to work the same way.
American consumers, insurers and health care providers could potentially save billions of dollars a year by using cheaper versions of brand-name biologicals that now cost tens or hundreds of thousands of dollars a year per patient. States should not move to limit access to biosimilar drugs before the F.D.A. has issued final guidelines on how to ensure their safety. In their lobbying campaign, revealed by Andrew Pollack in The Times recently, the two companies have persuaded legislators to introduce bills that would restrict the ability of pharmacists to substitute cheaper biosimilars in filling prescriptions.