Biosimilars: what’s in a name?BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g272 (Published 17 January 2014) Cite this as: BMJ 2014;348:g272
- Ed Silverman, founding editor of Pharmalot.com
What’s in a name? For the biopharmaceutical industry, much is at stake in answering this simple question. Around the globe, drug makers, biotechnology companies, and their generic rivals are sparring over the nomenclature assigned to biosimilars, which are designed to emulate brand name biologics and are forecast to save untold billions of dollars in healthcare costs in coming years.
At issue is whether biosimilars should be given the same International Proprietary Name, or INN, as brand name biologics. The global INN system is overseen by the World Health Organization, although its recommendations are not mandatory, which is causing growing anxiety among some drug makers, since regulators in different countries are free to pursue different approaches for identifying biosimilars.
Brand name drug makers and biotechnology companies want biosimilars to have unique, non-proprietary, or generic names to distinguish the medicines from the original biologics, which differ from other drugs because they are created by biological processes, rather than being chemically synthesized. In the view of the brand name drug makers, distinct names would lessen confusion in the marketplace and, therefore, ensure patient safety. But generic drug makers disagree and believe that creating a new standard for biosimilars would, in fact, create confusion.
“The overall thrust is to create a market that has coherent names and that healthcare practitioners can understand,” says Roger Williams, chief executive officer at the US Pharmacopeial Convention, the non-profit organization that sets standards for the identity, strength, quality, and purity of medicines. “ . . . Unfortunately, I’d say we’re at a period of maximum confusion.”
Debate over different INNs for biosimilars
A central point of contention is whether different INNs would hamper substitution needed for lowering healthcare costs. “If pharmacists or physicians see a …