New Phase Will Increase Trajectory of Biosimilar Use in the United States, Expert Says

While there are currently only 2 biosimilars with interchangeability designation, having more interchangeable biosimilars will start becoming a more important pharmacy benefit as biosimilars reach the US market, explained Jeffrey Casberg, MS, RPh, vice president of pharmacy at IPD Analytics, LLC, during a session at Asembia’s Specialty Pharmacy Summit, held May 2-5 in Las Vegas.

Casberg’s organization is tracking products that either have interchangeable biosimilars or that will have them in the future. On the radar are:

• Adalimumab (Humira) 50 mg/ml
  • Cyltezo already has interchangeable status and its potential launch date is July 1, 2023
  • Abrilada is seeking interchangeability and will likely have it for its July 1, 2023, launch
  • Amjevita has a launch date of January 1, 2023, and will likely receive the interchangeability designation post launch, possibly in 2024
  • Hadlima will launch June 30, 2023, and will likely receive interchangeability after launch
• Adalimumab 100 mg/ml
  • AVT02 has already submitted for interchangeability; it is not yet approved, but it will likely have interchangeability at launch
  • Hadlima will likely receive interchangeability after its potential launch date for this dosage
  • ABP 501 HC is seeking interchangeability with a potential launch in 2023 or later
• Infliximab (Remicade)
  • NI-0171 has completed interchangeability studies and has a potential launch in 2024 or later
  • Infliximab, which launched as an interchangeable unbranded biologic in 2021
• Ustekinumab (Stelara)
  • ABP 654 has a completed phase 3 analysis to support interchangeability and its launch is expected to be 2023 or later
• Golimumab (Simponi Aria)
  • AVT05 is seeking interchangeability but would not launch until February 2024 or later

There is even more potential interchangeability among the insulins. There are 3 products: short-acting insulin lispro (Humalog), short-acting insulin aspart (NovoLog), and long-acting insulin glargine (Lantus). There is already an interchangeable biosimilar for insulin glargine (Semglee).

The most excitement remains around the adalimumab biosimilars, but there is some uncertainty how they will change the market trends. Right now, all of the approved adalimumab biosimilars are for the original 50 mg/ml formulation, which only has 20% or less market share.

“Payers are going to have to develop plans to move people—85% of the market—from the new formulation back to the old formulation,” Casberg explained, and it’s “unclear how successful that conversion would have been.”

However, there was recently an agreement between AbbVie, the maker of Humira, and Alvotech to allow a new formulation adalimumab biosimilar to launch mid 2023.

“Instead of this big hurdle and messy conversion…now, we're going to have both the old formulation and new formulation of adalimumab,” he said. This is easier for pharmacies, which won’t have to deal with the conversion, and payers, which won’t have to send letters to patients and providers explaining the conversation. Ultimately, having biosimilars available for both formulations will “make this adoption much more robust.”

According to Casberg, 2021 has brought the US biosimilar market into a new phase. The initial phase was 2013 to 2020. During this phase, the drugs were on the medical benefit side, and they were mostly less competitive. In the new phase, there are bigger brand names, pharmacy benefit drugs, more competitive therapeutic classes, interchangeable biosimilars are entering the market, and some of these biosimilars will be self-administered, he explained. However, in this new phase, there will also be physicians in specialties who are less familiar with biosimilars.

“So, I think we're going to start to see an increase in trajectory of the use of biosimilars in the United States,” Casberg said.