ASHP: Adalimumab Biosimilar Pipeline Review

Biosimilars are in the spotlight at the 2023 American Society of Health-System Pharmacists (ASHP) Summer Meetings and Exhibition.¹ “[I think] this is going to be a hot topic [for the rest of the meeting,” said Courtney Queen, PharmD, CSP, of the University of Kentucky Specialty Pharmacy and Infusion Services in Lexington, Kentucky, during her presentation on the specialty pharmacy pipeline.

Over the next 5 years, multiple biosimilars medications are set to join the 41 that have already gained FDA approval, including biosimilar products to ustekinumab (Stelara), golimumab (Simponi), certolizumab pegol (Cimzia), and etanercept (Enbrel). The bulk of biosimilars being released in 2023, however, represent significant competition to behemoth anti-tumor necrosis factor-a monoclonal adalimumab (Humira), approved to treat a slew of conditions including rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, among others.

The flood began as a trickle in January 2023 with the launch of adalimumab-atto (Amjevita), approved in 2016 as the first adalimumab biosimilar. By July 1, adalimumab biosimilars adalimumab-abdm (Cyltezo), the first interchangeable adalimumab biosimilar; adalimumab-adaz (Hyrimoz); and adalimumab-aqvh (Yusimry), will join the list of available products.

“Most of the [adalimumab biosimilar] products are citrate free, which is a big deal,” Queen said, citing the patient friendliness of the current adalimumab citrate free product.

Several high concentration products are also slated for release this July as well, all of which are citrate free. “These are going to be more similar to what patients are currently used to, the lower volume with the higher concentration,” Queen said.

The other elephant in the room around adalimumab biosimilars is price. “I know we’re all kind of interested to see what the plans are going to prefer,” Queen said. Adalimumab-atto is currently priced on formulary at parity with adalimumab. But as more adalimumab biosimilars are released, Queen is eager to see how this pricing structure changes, and if these products will be priced more closely to generic medications.

Interchangeability of these products remains an open question, with laws and guidelines varying on a state-by-state level. “Interchangeability would provide potentially a chance for [a specific biosimilar] to gain a bigger market share, as you would automatically interchange that product no matter…if the brand-name product was written, whereas other [biosimilars] would need to be written by name.”

With the sheer number of adalimumab biosimilar products about to be made available, health care providers must keep the patient perspective in mind. “What else makes them different?” she asked. Outside of prior authorization and other payer-related concerns, considering the most patient-friendly products is important. “Think about a rheumatoid arthritis patient with limited functionality in their hand. They may be more concerned with [autoinjector pen size],” and prefer a smaller pen device that they can more easily use. “It’s going to be really interesting to see all the different products and what small nuances they have.”

Reference

1. Rim M, Queen C, Huffmyer M. Specialty pharmacy pipeline updates II: Emerging therapies for complex conditions. Presented at: American Society of Health-System Pharmacists Summer Meetings and Exhibition; June 10-14, 2023; Baltimore, MD.