Biosimilar agents will arrive in the United States relatively soon as an option to treat inflammatory bowel disease, and could lower costs and increase access to therapies potentially as effective as the biologic agents, says Cleveland Clinic gastroenterologist Bret Lashner, MD.
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This economic incentive, combined with biologics coming off patent and positive reports from Europe, could drive imminent approval in the United States, Dr. Lashner says. “My guess is these will become available very shortly, probably within a year.”
In the meantime, gastroenterologists and other physicians face some unanswered questions. For example, how will their efficacy compare to biologic agents, what will the FDA require for marketing approval, and how should doctors counsel patients if balancing cost and efficacy becomes a factor?
“The biologic agents, especially the anti-TNF agents, have basically revolutionized the way we treat patients with inflammatory bowel disease,” Dr. Lashner says. “We now have effective therapies, hospitalization-reducing, surgery-reducing, life-changing therapies. These are drugs that change the natural history of the disease for the better.”
Given this level of efficacy, why would many anticipate considerable changes once biosimilars gain U.S. approval?
“These excellent therapies are not really available to all patients because of the costs,” Dr. Lashner says. So if biosimilars offer similar efficacy at lower cost, they could expand the number of patients who can access this kind of therapy for chronic management of Crohn’s disease or ulcerative colitis.
Biosimilars cost as much as 30 percent less than biologics in Europe, physicians reported at the Advances in Inflammatory Bowel Diseases conference in December 2015.
The biosimilar agent to infliximab, known as CT-P13 in Europe and Asia, “is showing promise as being an effective anti-TNF agent at a much lower cost,” Dr. Lashner says. Even so, he wants to see more rigorous evidence such as large, prospective studies for all biosimilar therapies.
In the United States, the biologic adalimumab (Humira®, AbbVie) faces patent expiration in December 2016. Infliximab (Remicade®, Janssen) faces the same status in 2018.
“This gives an opportunity for other people to develop agents that are similar, but not identical, that can be introduced to the market,” Dr. Lashner says.
Caveats and other considerations
Biosimilar efficacy is likewise important.
“They can be less effective, but not much less effective [than biologics],” Dr. Lashner says. “We have a lot of happy patients that are on these drugs, and to tell them ‘Yes, this is cheaper but it won’t work as well,’ they’re going to be unhappy.”
Because of their relatively high cost, prescribing biologics already requires exacting pre-authorization from insurers.
“They are very, very costly, to the point where insurance companies are balking at approving them without a very good indication,” Dr. Lashner says. Biologic agents cost approximately $40,000 to $50,000 per year, an amount few of his patients can afford out-of-pocket.
Once available, “non-medical substitution” of biosimilars becomes likely. In other words, insurance companies will likely mandate automatic substitution of a less expensive biosimilar, unless a physician provides a convincing justification for a biologic agent.
“This happens all the time for other drugs. The insurance companies won’t approve an expensive drug where there is a cheaper drug,” Dr. Lashner says. “They may be tying our hands.”
Awaiting more evidence
Gastroenterologists at Cleveland Clinic will decide how to incorporate biosimilars into their treatment of inflammatory bowel disease as evidence emerges. Dr. Lashner says, “We’re going to have to evaluate the information when it becomes available.”
It seems that the only certainty is that biosimilar agents are forthcoming in the United States.
“Certain pharmaceutical companies will be negotiating with the FDA to get biosimilars to the market as quickly as possible,” Dr. Lashner says.
Interestingly, when President Obama signed the Affordable Care Act in 2010, it included a provision called the Biologics Price Competition and Innovation Act of 2009. The Act could speed up approval because it eases the requirements for agents shown to be highly similar to or interchangeable with biologics already cleared for marketing in the United States. In essence, this means biosimilars would need fewer data from preclinical and clinical studies to gain FDA approval.
Dr. Lashner’s advice to colleagues?
“Keep your eye on this literature. It is going to affect you. These drugs are coming to the U.S.” He adds, “Hopefully they will be safe, effective and much cheaper than what we have right now.”