Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains why REMS programs give biosimilar and generic drug developers cause for concern.
What are REMS programs, and why are some stakeholders concerned about them?
A: REMS programs are safety programs that, again, were enacted back in 2007 and they are designed to allow the FDA to approve a drug even if it might have some safety issues that typical risk mitigation programs can’t address.
For drug products, the main way that FDA reduces risks is by identifying them on the label so that physicians know what the risks are and can take appropriate steps with their patients. In some cases, maybe not give a particular medication to a patient if the risks are too great. I think the conclusion FDA came to is that they can’t really trust physicians. Physicians don’t read the label and will use medicines even when the label says they shouldn’t be used. [The FDA] asked congress for the authority to take stronger measures, and 1 of the measures they got was a REMS.
The REMS provisions allow FDA to impose things like distribution and use restrictions. For instance, it might require special training for a physician to be able to prescribe the medicine, or it might say you may only use it in a certain facility as safeguards. They did really restrict how a medicine can be used and distributed. The concern folks have, particularly biosimilar manufacturers, is that brand companies that have drugs that are subject to a REMS are using them to prevent generic competition. They do that in 2 ways: the first is to restrict samples of the brand. So if you’ve got a generic product or a biosimilar, you need to get samples of the brand so you can conduct your tests. For a generic, it’s bioequivalence tests, [and] for a biosimilar it’s to show biosimilarity. But the brands are essentially saying, “our product is subject to a REMS. We can’t give it to you because it just doesn’t comply with the REMS requirements.” That prevents companies from doing the testing that they need to submit the application.
The second concern is that, and this is just for generics, not for biosimilars, but for generic products there’s a requirement that the generic, if it gets approved, must have a single shared REMS. It must essentially share the REMS that the brand already has. A lot of times, companies will delay agreeing, and the generic cannot get approved unless it has a single shared REMS. The concern is that you’re supposed to negotiate with a party that really has no interest in agreeing with you, and [those are] the main 2 concerns with the REMS.