Battle over naming of biosimilar drugs

A battle is shaping up between biotech companies and the Generic Pharmaceutical Association (GPhA) over the naming of biosimilar drugs. Biosimilars, or “follow-on biologics,” are products whose active ingredient is an approved version of a previously approved biopharmaceutical. Since biologics are generally manufactured in a complex process that may include molecular clones and proprietary cell lines, it is virtually impossible for the manufacturers of a biosimilar to match the process step-by-step. This results in small differences between the innovator product and the follow-on product (hence the name “biosimilar”). With billions of dollars of revenue at stake, biotech companies, such as Genentech and Amgen, have been lobbying federal and state legislators to tighten the rules regarding use of biosimilars. There has also been concern that the FDA might prohibit biosimilar manufacturers from using the same generic name as the original drug, a move that biotech companies would endorse and the GPhA would strongly oppose. A bipartisan group of senators recently entered the fray by penning a letter to the FDA urging the agency to allow biosimilars to share the name of the innovator product. Led by Republican John McCain and Democrats John Rockefeller and Tom Harkin, six senators urged the FDA to follow the intent of the Biologic Price Competition and Innovation Act, suggesting that if biosimilars were not allowed to share the same name it would undermine “the safety and accessibility of affordable biosimilars.” The FDA had been in support of allowing biosimilars to share generic names, but the sudden removal of a page from the FDA website that contained a 2006 statement supporting same-name biosimilars prompted the concern of the senators.