(Very Flawed) Biosimilars Bill Introduced

Yesterday, Reps Henry Waxman (D-CA), Frank Pallone (D-NJ), and Nathan Deal (R-GA) introduced a bill to establish an approval pathway for biosimilars. If you don’t get into the details, it seems like a great development. Many in the biotech community (even innovator companies) have been saying for years that we need a pathway for the review and approval of biosimilars. But when you get to the fine print, this bill hurts much more than it helps…

The first major issue with the bill has to do with patient safety:

As the U.S. Food and Drug Administration (FDA) has noted, biotech drugs are so molecularly complex that they are almost impossible to map accurately with existing science. Even minor differences in the purity of a biotech drug can change its efficacy and safety. We can take no short cuts to safety when it comes to biosimilars.

The second issue has to do with the time allotted for data exclusivity (the period when the innovator company has exclusive rights to data it submitted to the FDA for the product they developed). This bill sets out to cut prices for consumers by limiting this period, but instead it jeopardizes the ability of innovator companies to continue developing therapies and potential cures for debilitating diseases by setting unfair timelines for generic companies to come in benefit from their years of research and investment. I know there’s an elephant in the room on this one, so let’s just take it head on: this isn’t about greed. It’s about ensuring that innovator companies can recoup the vast amounts of money they spend developing a treatment and make enough to fund their next big breakthrough.

The fate of this particular bill is unclear. As Patent Baristas points out, this is not the first time a follow-on biologics bill has been introduced. ( A similar bill came up and failed last year.) What is clear is that this is going to be one heck of a debate…and we’ll keep you up to date as it unfolds.

For more resources on follow-on biologics, click here.