Expert: Expectations are high that biosimilars can control overall biologic cost growth.
Johnson & Johnson’s autoimmune disease drug Remicade (infliximab) will now have a biosimilar, a federal court ruled.
The court ruled that J&J’s patent was invalid for Remicade, which was originally licensed in 1998. Lower-priced Inflectra (infliximab-dyyb, Pfizer), a biosimilar to Remicade, was approved in April and likely will launch in October. Janssen Biotech, a J&J subsidiary said in a press release that it is “disappointed with the court's ruling and plans to appeal the decision to the Court of Appeals for the Federal Circuit.”
“Inflectra . . . would be the second biologic to launch under the biosimilars pathway created by the Affordable Care Act, Zarxio [filgrastim-sndz] being the first,” according to Valerie Reynolds, senior director at ADVI. Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s cancer drug Neupogen (filgrastim).
“Inflectra would be the first therapeutic and the first immunology product. [The drug’s] launch would provide additional data on how biosimilars will affect the market,” Reynolds says. “In 2017, we are expecting biosimilar launches that will compete with infliximab-adalimumab and etanercept-biosimilars that will be reimbursed under the pharmacy benefit instead of the medical benefit.”
Health executives will soon have another option for treating patients suffering from relatively common inflammatory conditions, such as rheumatoid arthritis and Crohn’s disease, according to Julie Rubin, PharmD, director of clinical services, CompleteRx. "Pfizer has yet to disclose the estimated price of Inflectra; however, based on trends, it’s likely to be as efficacious as, but less expensive than J&J’s version. Most importantly, perhaps, this will introduce new competition-the lack of which is a primary driver of the rising drug costs that have recently plagued hospitals-that may reduce treatment costs overall."
Regardless, this is an important opportunity for health executives to pull together interdisciplinary teams to evaluate their formularies, and determine whether this drug, and other biosimilars to follow, will enable them to optimize patient care, according to Rubin.
To review pricing for the first launch, Zarxio, has a reported per unit average sales price (ASP) dropped almost 10% between September 2015 and July 2016, whereas the ASP for Neupogen remained stable during the same period, according to Reynolds.
“As such, Zarxio’s ASP represented a 3% discount from Neupogen in September and a 13% discount in July 2016,” she says. “However, the discount provided by Zarxio is still smaller than estimated by Congressional Budget Office [CBO] when scoring the biosimilars pathway under the ACA-CBO estimated discounts between 20% and 40% off of the reference product.”
Next: Controversial CMS policies
According to Reynolds, CMS has created various policies that will affect the market-the most controversial are below:
· Under Part B, CMS will implement shared billing and payment codes for biosimilars of the same reference product; and
· Under Part D, CMS will treat biosimilars like generic drugs, and as such will not collect and apply manufacturer rebates to beneficiary out-of-pocket spending.
“There are high expectations that biosimilars can control overall biologic cost growth,” Reynolds says. “Stakeholders will be watching the launch of these initial biosimilars carefully, and in particular focusing on whether the policies CMS has implemented can deliver a competitive and stable market for biosimilars.”
Rubin agrees. "Execs need to understand that biosimilars are a rapidly growing field," she says. "Thirty-six states have considered legislation establishing standards for substituting biosimiliars. [CMS] hopes that Medicaid and other insurers see this as an opportunity to achieve measurable cost savings and greater beneficiary access to expensive therapeutic treatments for chronic conditions. New biosimiliars are coming available monthly."
A biosimiliar for the insulin Lantus may be on the horizon, according to Rubin.