Delayed launches and patent litigation limit biosimilar availability

Even though 12 have been approved, what’s the reality for biosimilars in the U.S.?

FDA has had a busy 2018 on the biosimilar front, approving three products last spring and summer: epoetin alpha-epbx (Retacrit—Pfizer) in May, pegfilgrastim-jmdb (Fulphila—Mylan) in June, and filgrastim-aafi (Nivestym—Pfizer) in July, bringing the total number of biosimilars currently approved in the United States to 12.

With so many approved products, it seems that the biosimilar market in the U.S. is taking off. But in reality, approval doesn’t mean the products will be commercially available. Of the 12 biosimilars currently approved, only four are currently available. Amgen has said in statements that it will not launch adalimumabatto (Amjevita) until 2023, and Pfizer has announced that infliximab-qbtx (Ixifi) will not be available in the U.S. The remaining six approved biosimilars did not have launch dates as this article went to press, several because of patent litigation.

Should more biosimilars enter the U.S. market, they could help control costs and improve care, said Jesse Peterson, PharmD, MS, CSP, clinical development manager at Fairview Pharmacy Services in Minneapolis.

“As more products become commercially available, we expect to see lower prices of these agents with increased competition. These lower prices could in turn lead to preferred formulary placement across the medical and pharmacy benefit, in turn enabling providers to gain more experience and confidence with these agents,” Peterson said.

Still, there are a few key points you’ll need to remember as these products make their way to your pharmacy, Peterson said.

“While biosimilars are highly similar to their reference products with no clinically meaningful differences, they are not interchangeable. Without interchangeability criteria, you aren’t able to make switches at the pharmacy level,” Peterson said. “Keep in mind that as lower cost options become available, health plans will likely prefer the biosimilars, but if the prescriber writes the prescription for the [reference] product and it’s not covered, you can’t make the switch. You’ll have to go back to the prescriber to say that the health plan isn’t covering the [reference] product.”

For the full article, please visit for the October 2018 issue of Pharmacy Today.