I’ve never been a huge fan of dumbing things down. Letting things slide when the right thing to do is to correct something. Take my approach to parenting. Sometimes the easiest thing to do, while talking to my kids at the dinner table, is to not correct their verbal mistakes. In ones so young, mistakes in the correct use of language are inevitable. But to let things slide, to not correct them, is bad parenting.
We’ve reached a point in the biosimilars market where we’re all sitting at the proverbial “dinner table.” Talking about how the market could play out. Where it’s headed. And what challenges still remain (of which there are many). It’s a busy table. Everyone wants to have their say. To take center stage. It’s an exciting place to be. But sometimes people use language that, in my opinion, needs to be corrected.
Take the words “knock off” and “copycat”. These two words, phrases, clichés, whatever, you want to call them, have become media bywords for biosimilars. Both words are associated with counterfeit, sub-standard products. Like handbags, sunglasses and watches. It’s a huge shame that this has happened. And I’d like to give my two cents worth on why.
Biosimilars have been used in Europe since 2006, when Omnitrope (a somatropin biosimilar) from Sandoz was approved and launched. Since then we’ve had over 20+ other biosimilars approved and launched in Europe, the US, Japan and other highly regulated markets. According to Medicines for Europe, EU-approved biosimilar medicines have generated more than 400 million patient days of clinical experience worldwide. And the number of safety issues? None. The number of product recalls? None.
Biosimilars are high quality, safe and effective products. They meet stringent regulatory requirements in many countries around the world. And even in markets which have been associated with lower regulatory standards for biosimilars in the past, there are signs that standards are improving. To call them “knockoffs” or “copycats” is disingenuous.
But I can understand why these words are used. It’s easier than trying to explain the science behind biosimilars. I get that. But I’m still not a fan. It just doesn’t sit well with me. It gives the wrong impression to people who don’t understand the space. Like parenting, we have a responsibility to teach those that don’t understand something. As for what synonym is best to describe a biosimilar without resorting to “knockoff” or “copycat”? I’m still pondering on that, and I welcome your suggestions…