Biosimilar Adalimumab-aacf Gains FDA Approval, Marks Growing Interest in Biosimilar Development

In December 2022, the FDA approved the biosimilar adalimumab-aacf (Idacio), a citrate-free formulation of adalimumab. In an interview with HCPLive, Brandee Pappalardo, PhD, Senior Vice President and Chief Medical Officer, US Medical Affairs, at Fresenius Kabi, spoke about the newly approved biosimilar and what this means for the future of treatment for patients with rheumatic diseases and the clinicians tasked with choosing the right drug. The tumor necrosis factor (TNF) inhibitor is set to launch commercially in the US in a self-administered prefilled syringe and a self-administered pre-filled pen in July 2023.

“The approval is the signal in the beginning of kicking off what we know is going to be a very long-term dedication to biosimilars,” Pappalardo stated. “This is something we are incredibly committed to.”

Pappalardo emphasized the difficulties of getting biosimilars to market in the United States. However, the benefits of incorporating biosimilars are clear, including increasing access to the drug and the cost-saving implications across the healthcare industry.

“Particularly with rheumatic diseases, if you treat them early, you can prevent joint degradation, bone degradation, and those patients can have a better quality of life,” Pappalardo started. “But they've got to get that drug at the right time.”

The approval of adalimumab-aacf was based on comprehensive data, including clinical trials in psoriasis and rheumatoid arthritis, which demonstrated a similar analytical profile, safety, efficacy, and immunogenicity to the reference adalimumab product.

Correction: Cost-savings are projected to be $100 billion by 2025, not $1 billion as stated by Pappalardo.