How Biosimilars May Alter the Landscape of Pharmacy

October 3, 2016

Michael Reilly is the executive director of the Alliance for Safe Biologic Medicines (ASBM), a coalition created to inform health care professionals and policymakers about the role biosimilars can play in safe and effective patient care and to ensure patients have access to the new class of medicines. Mr. Reilly previously served as the associate deputy secretary at the US Department of Health and Human Services, where he was actively involved in the creation of regulations enacted by the Centers for Medicare & Medicaid Services (CMS). At ASBM, he’s now on the administrative side of medication development. Mr. Reilly brought his unique perspective to a recent conversation about the US Food and Drug Administration’s (FDA) approval of adalimumab-atto (Amjevita) as a biosimilar to Abbvie’s adalimumab (Humira), the current state of biosimilar development and why pharmacists are sitting on the cusp of the large molecule medicine revolution.


PLN: Is the FDA moving quickly enough to approve biosimilars?

Mr. Reilly: There are a lot of experts who want the agency to speed up the process. Look at the lag time between the FDA’s initial draft guidance about biosimilars in 2012 and the first biosimilar approval (Zarxio) in March 2015. The agency does tend to move cautiously, but the development of new agents is now humming along relatively well. The US is on pace to have as many as 9 biosimilars approved by next year. Compare that with Europe, which has had biosimilars for 10 years and has approved only 20. We’ll pass Europe in a few years, and in a much shorter timeframe.

PLN: The FDA approved Amgen’s Amjevita, but Abbvie is claiming they hold the patents for Humira. How will that play out?

Mr. Reilly: It’s interesting that the legal debate is between two established, innovator companies battling over Humira, which is such a well-known product. The question really becomes, once the companies resolve the legal wrangling, is how the approval will impact use of the drug. Amgen is looking to make a lot of biosimilars and they have some built in advantages in terms of the approval process that other companies without a history with biologics simply don’t have. It’s going to take more than one or two players to drive down the therapy’s price. This is the first big test.

PLN: What do you mean?

Mr. Reilly: The cost to manufacture biosimilars is much different than the cost to manufacturer generics, so ultimately there will be fewer companies that can produce biosimilars with acceptable standards in quality, safety, and efficacy. Zarxio entered the market at 15% below the cost of its innovator product. When you’re talking about compromised patients who work for years to get to a stable condition, is that 15% mark down enough incentive to take a chance on a biosimilar? That doesn’t mean biosimilars are risky, but patients with liver cirrhosis, rheumatoid arthritis, multiple sclerosis, or cancer—diseases that take time to stabilize—might not want to alter their current therapies. But from the government’s perspective, the aggregation of those savings from an entire patient population can result in significant savings.

PLN: Where do you stand on the biosimilar naming debate?

Mr. Reilly: The ASBM has surveyed a lot of physicians and pharmacists, and most overwhelmingly believe that biosimilars should have distinguishable names, and most want the names to be memorable. We think it’s important that the manufacturers of biosimilars are identifiable, because pharmacovigilance is really the ultimately purpose of distinguishable names, which are needed to better track a product, and to know what a patient has taken. The main goal of tagging biosimilars with memorable names is to allow pharmacists and physicians to more easily recognize biosimilar products. Because of their experiences with generics, there’s an assumption that a shared name means the drugs are approved for the same indications and that they have the same exact composition. There’s historical meaning to a shared name in the context of generics and small molecule drugs, but distinguishable names are needed for large molecule biosimilars, because of potential differences in immunogenicity.

PLN: What role will pharmacists play in the acceptance of biosimilars along the frontline of care?

Mr. Reilly: Biosimilars are the future of medicine. Medicine is trending away from small molecule drugs to large molecule medicines, and pharmacists want to be on the front end of the movement. They need to recognize that they must play a more prominent role on medical teams. Pharmacists are obviously a great point of contact for educating patients, even more so in some respects than physicians. But before pharmacists can educate patients, they need to be educated about biosimilars and the basic differences between small and large molecule drugs.


—Dan Cook