First Interchangeable Biosimilar to Humira Gets Approval for Pen Form

The FDA granted approval of Boehringer Ingelheim’s Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), the first Interchangeable biosimilar to AbbVie’s Humira (adalimumab).

The FDA cleared Cyltezo in pre-filled syringe form in August of 2017 and was granted an interchangeable designation in October of 2021. Cyltezo is indicated to treat multiple chronic inflammatory diseases including rheumatoid arthritis.

The 40 mg/0.8 mL pre-filled Cyltezo Pen will be available in two-, four- and six-pack options on July 1, which is the same date Cyltezo is available. The date was the result of a patent ligation with AbbVie. Boehringer Ingelheim will pay royalties to AbbVie for licensing its Humira patents once Cyltezo is available.

While Boehringer Ingelheim executives cannot comment directly on the wholesale acquisition cost (WAC) of Cyltezo until it is commercially available, Stephen Pagnotta, executive director and biosimilar commercial lead for the company told Formulary Watch, “we can confirm that Cyltezo will be priced competitively to other biosimilars approved by the FDA.”

“Additionally, we are actively working with payers to gain broad formulary access for when Cyltezo launches later this summer,” Pagnotta said.

The “patient-centered design” of the pen features a one-button, three-step activation, with 100% drug visibility and a protected needle, Boehringer Ingelheim said. The Arthritis Foundation has certified the Cyltezo Pen as an "Ease of Use" product.

FDA’s approval of the pen form of the medication is “great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector," said Pagnotta in a news release.

To be a biosimilar to an approved reference biologic, companies must demonstrate there are no clinically meaningful differences in terms of safety, potency and purity. Cyltezo was approved by the FDA in August 2017 for the treatment of multiple chronic inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn's disease.

Then, in late October 2021, Boehringer Ingelheim updated the safety labeling of Cyltezo with data from the trial that was used to support its application for interchangeability with Humira.

Interchangeabiity is a separate, additional regulatory designation on top of the high FDA standards for a biosimilar. In addition to first meeting the requirements of biosimilarity, an interchangeable biosimilar must additionally demonstrate that the risk in terms of safety or diminished efficacy of switching with the reference product is not greater than staying on the reference product. This requirement is satisfied through an additional study of multiple switches in patients.

While AbbVie’s U.S. sales of Humira soared 9.9% to more than $5 billion in 2022, the company is expected to lose significant revenue as a number of Humira biosimlars come to market this year.

Amgen was the first to launch a biosimlar to Humira in late January. Amjevita (adalimumab-atto) is available with two pricing options. The first is a 5% below the current Humira price of $6,922 for a four-week supply. The second is 55% below the current Humira list price, Amgen said at the time.

In December, the FDA approved Fresenius Kabi’s Humira biosimilar Idacio to treat patients with chronic autoimmune diseases. Fresenius Kabi plans to launch the product in the U.S. in a self-administered prefilled syringe and a self-administered pre-filled pen (autoinjector) in July 2023.