Boehringer Ingelheim Expands Adalimumab Biosimilar Access Through Agreement with Quallent Pharmaceuticals

Boehringer Ingelheim has announced it will be expanding access to their citrate-free adalimumab biosimilar, adalimumab-adbm injection, through an agreement with Quallent Pharmaceuticals.

Announced on May 13, 2024, terms of the agreement mean Boehringer Ingelheim willmanufacture adalimumab-adbm for Quallent and Boehringer Ingelheim will continue to commercialize Boehringer Ingelheim-labeled Cyltezo(adalimumab-adbm) injection and adalimumab-adbm. According to the announcement from Boehringer Ingelheim, Quallent will be offering both high-concentration (40 mg/0.4 mL) and low-concentration (40 mg/0.8 mL) citrate-free formulations of adalimumab-adbm as a pre-filled syringe or pen and adalimumab-adbm’s interchangeability designation for the low-concentration formulation will extend to Quallent’s 40 mg/0.8 mL private-labeled adalimumab-adbm.

“Boehringer Ingelheim is dedicated to broadening access to essential biologic medicines, and our collaboration with Quallent will increase availability of our adalimumab biosimilar for patients living with certain chronic inflammatory diseases,” said Chris Marsh, Senior Vice President of Value and Access at Boehringer Ingelheim. “The utilization of biosimilars such as adalimumab-adbm provides the potential for more patients to benefit from biologic medicines and saves costs for both patients and the U.S. healthcare system overall. We’re committed to helping the biosimilar market reach its potential, and this partnership is an important step in enabling greater adoption of these lower-cost options.”

In the world of biosimilars, outside of oncology, few agents have garnered the same attention as adalimumab biosimilars. With the reference product boasting a multitude of approvals for chronic inflammatory disorders, there has been more than half a dozen adalimumab biosimilars to receive approval since Amgen’s Amjevita (adalimumab-atto) became the first adalimumab biosimilar approved in the US in 2016. Among the multitude of biosimilars to be approved is adalimumab-adbm, which received approval in August 2017 and launched as Cyltezo in July 2023. A subsequent unbranded launch of adalimumab-adbm occurred in October 2023.

On May 1, 2024, the US FDA approved a high-concentrate, citrate-free formulation of subcutaneous adalimumab-adbm. This approval was based on the phase 1 VOLTAIRE-HCLF clinical trial, which examined the bioavailability of high-concentration (100 mg/mL) and low-concentration (50 mg/mL) formulations of adalimumab-adbm.

“We are pleased to be working with Boehringer Ingelheim to bring adalimumab-adbm to more patients. Our intent is to offer a copay assistance program, which will provide eligible patients access,” said John Caulfield, President of Quallent Pharmaceuticals Health, LLC. “Quallent was established to help pharmacies give their patients safe and affordable medication, and this collaboration will help us deliver on this goal.”

References:

1. Boehringer Ingelheim. Boehringer Ingelheim expands access to adalimumab-adbm injection, the company’s biosimilar to Humira. Boehringer Ingelheim. May 13, 2024. Accessed May 13, 2024. https://www.boehringer-ingelheim.com/us/new-agreement-quallent-expands-biosimilar-access.
2. Joszt L. First Humira biosimilar, Amjevita, launches in the United States. AJMC. January 31, 2023. Accessed May 13, 2024. https://www.ajmc.com/view/first-humira-biosimilar-amjevita-launches-in-the-united-states.
3. Pine L. FDA approves high-concentrate, citrate-free formulation of biosimilar adalimumab-ADBM. HCP Live. May 1, 2024. Accessed May 13, 2024. https://www.hcplive.com/view/fda-approves-high-concentrate-citrate-free-formulation-of-biosimilar-adalimumab-adbm.