FDA Approves Cyltezo for Inflammatory Diseases

The recent approval by the US Food and Drug Administration (FDA) allows Boehringer Ingelheim to market its high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) as an interchangeable biosimilar to Humira (adalimumab). This development enables Cyltezo to be utilized in treating various chronic inflammatory conditions.

The newly approved formulation features a 100mg/mL concentration and is available in the form of a pre-filled syringe or pre-filled autoinjector. This version of Cyltezo is priced competitively, offering a 5% discount compared to branded Humira and an 81% discount when sold as the unbranded product Adalimumab-adbm. Prior to this, a lower concentration version of Cyltezo at 50mg/mL has been available on the market since July 2023.

The FDA's approval is based on data from the VOLTAIRE-HCLF clinical trial, a Phase I study that assessed the bioavailability of both the high-concentration and low-concentration formulations of adalimumab-adbm. This is not the first time Cyltezo has received regulatory backing; it was initially approved by the US FDA as an interchangeable biosimilar to Humira in October 2021. The product’s efficacy and safety have been well-documented through extensive research, including findings from the Phase III VOLTAIRE-X clinical trial. This particular study examined the effects of multiple switches between Humira and Cyltezo compared to continuous treatment with Humira alone.

Stephen Pagnotta, Boehringer Ingelheim's Biosimilar commercial lead and executive director, expressed enthusiasm about the new approval. He stated that the FDA's latest nod allows them to offer both high and low-concentration, citrate-free formulations of Cyltezo, thereby broadening treatment options for patients suffering from chronic inflammatory diseases. According to Pagnotta, a significant number of patients are treated with high-concentration adalimumab formulations, and the new option expands access and flexibility for those in need.

This approval is a key milestone for Boehringer Ingelheim, further solidifying its presence in the biosimilar market. It also follows a strategic collaboration between Boehringer Ingelheim and Ochre Bio aimed at discovering and developing new regenerative treatments for chronic liver diseases. This partnership underscores the company's commitment to advancing medical research and providing innovative solutions for various health conditions.

In summary, the FDA's approval of Boehringer Ingelheim’s high-concentration, citrate-free Cyltezo as an interchangeable biosimilar to Humira marks a significant advancement in the treatment landscape for chronic inflammatory diseases. With competitive pricing and the availability of both high and low-concentration options, this new formulation is poised to increase patient access and provide more treatment flexibility.