Regulatory News

Cassidy Says Obamacare Repeal Will Not Repeal Biosimilars Approval Pathway

Sen. Bill Cassidy (R-LA) told attendees of a policy briefing at the Newseum on Wednesday that when Republicans repeal Obamacare, which is expected to occur soon after President-elect Donald Trump takes office, the approval pathway for biosimilars that was created thanks to that law will not go away.

“I can imagine this provision will be carved out, if you will…part of the problem with the ACA [Affordable Care Act] is that it became so big that it was hard to totally implement…I can imagine this would be one of those things that would be kept,” he said.

As far as changes to the Biologics Price Competition and Innovation Act (BPCIA), Cassidy said he’d have to go through the BPCIA with a “fine-tooth comb” to figure out what needs altering.

“This isn’t the core of what people think of when they think of Obamacare,” he said.

In addition, repeating what other experts have said before, Cassidy warned of the potential for unwanted immunogenicity with biosimilars.

“The proteins even within the same infusion will have variability and that variability means what’s going in is a little different so the follow-on would also be a little different, which raises the question of immunological reactions…every batch is different so there’s always this risk for immunogenicity but whether the FDA is over-stating it or not, we just don’t know,” Cassidy said.