Rep Grothman Introduces Bill for Automatic Insulin Biosimilar Interchangeablity

A new bill (HR 8190) introduced in the House of Representatives would allow for biosimilar insulins to automatically be granted interchangeability designations. Interchangeable status enables prescriptions to be filled with lower-cost biosimilars, without a prescribing physician’s authorization.

Currently, the FDA has acknowledged that clinical and analytical evidence for the safety and efficacy of some insulin products may be strong enough to eliminate the need for additional studies to demonstrate interchangeability; however, its current policy is to not grant automatic interchangeable status for insulins that are approved as biosimilars.

In March, insulins transferred from being regulated under the Food Drug and Cosmetics Act to being regulated under the Biologics Price Competition and Innovation Act (BPCIA). HR 8190 will amend the Public Health Service Act portion of the BPCIA by deeming “any insulin that is determined…to be biosimilar to the reference product” would be interchangeable with the reference product.

The bill’s sponsor, Representative Glenn Grothman, R-Wisconsin, told The Center for Biosimilars^® in an interview that policies such as his are necessary to help lower costs for patients, especially those within the juvenile diabetes community, with whom Grothman regularly works.

“You've got a situation in which parents can be stuck paying hundreds of dollars, maybe $1000 a month for something their child needs to survive. And it's just really unacceptable,” Grothman said. "It crimps the whole family and puts them in a financially difficult situation. If we could get more access to biosimilars, we could make these folks lives much easier.

Removing barriers to interchangeability of biosimilar insulins would make insulin much more affordable for patients who need it, he said.

Details of the Bill

Grothman said that HR 8190, also called the Biosimilar Insulin Access Act of 2020, would apply to biosimilar insulins and clinically equivalent products that are not classified as biosimilars, such as Biocon and Mylan’s Semglee, which launched on the US market in August 2020. It also would apply to products that receive approval before and after the bill’s potential enactment.

Currently, there are no insulin products that have received interchangeability status from the FDA. However, Biocon and Mylan, are working to establish Semglee as an interchangeable biosimilar insulin. Semglee is not technically a biosimilar because it was approved under the former regulatory pathway under the Food Drug and Cosmetics Act, not under the BPCIA, which now governs insulin approvals.

The main limitation of the bill, Grothman said, concerns the interchangeability of biosimilars overall. Grothman said the bill is restricted to insulins because it’s likely going to be “easier to determine if a switch causes adverse reactions in patients on insulin than with other biosimilars.

“I would argue that it's a little bit safer, because people who need insulin are always getting check-ups. So, if there's something wrong, we find out right away,” he said.

Grothman added that, politically, addressing the interchangeability of biosimilar insulins is a good first step in the fight for similar changes to the way biosimilars are regulated and approved.

“If it works out, it's going to be hard for people for people to object….I think throughout life, once you demonstrate that one product works, it's easier to move on to a similar product and I hope that's what's going to happen here,” Grothman said.

Potential Challenges

After being introduced to the House, HR 8190 was referred to the House Committee on Energy and Commerce. Grothman’s next steps are to educate his fellow congressmen on the bill’s details in a search for co-sponsors and to build support for the measure.

“The more people hear about the potentially huge cost saving with biosimilars, the more Congress is going to be amenable to moving this on through," Grothman said. "And that's why we're going to ask for anybody to call your congressman, if you're familiar with the issue, and say, ‘Hey, what's going on? Why can't this bill move forward?’”

Going forward, Grothman anticipates some pushback from those with something to lose, such as those who view biosimilars as a threat to something they are already benefitting from.

“That's one of the reasons why it's all always difficult to get things through Congress,” he said.

Since March, 3 other biosimilar bills were introduced in Congress: a Senate bill aimed at waiving out-of-pocket expenses for biosimilars within Medicare Part B and companion bills in the House and the Senate regarding shared savings models. So far, none of them have moved further than committee referral.