Cyltezo, First Interchangeable Humira Biosimilar, Hits the Market

© hafakot stock.adobe.com

Cyltezo (adalimumab-adbm), the first Humira (adalimumab) biosimilar with an interchangeability designation from the FDA, became commercially available today, according to an announcement from its manufacturer, Boehringer Ingelheim.

The company is pricing Cyltezo at 5% to 7% below Humira’s wholesale acquisition cost of $6,922 for a four-week supply.

Stephen Pagnotta

Other companies are pursuing the interchangeable designation, but in interview this week with Managed Healthcare Executive®, Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim, said he expected Cyltezo to be only interchangeable Humira biosimilar for the next 12 months.

Optum Rx announced last week that it was putting Cyltezo on its formulary along with two other Humira biosimilars, Sandoz’s Hyrimoz (adalimumab-adaz) and Amgen’s Amjevita (adalimumab-atto). Pagnotta said Boehringer Ingelheim has “open dialogues” going with two other major pharmacy benefit managers (PBMs), CVS Caremark and Express Scripts about including Cyltezo on their formularies. He said the company is also in discussions with smaller PBMs but declined to give any specifics.

Related: Optum Rx Picks Hyrimoz and Cyltezo For Its Formulary

Boehringer Ingelheim has experience manufacturing biologics and will produce Cyltezo at the Fremont, California, facility where it makes many biologics, according to Pagnotta. But he noted that this the privately held company’s first experience launching a biosimilar.

“This launch will be a test for us. Can organizations like BI (Boehringer Ingelheim ) launch a biosimilar more like a branded product with the support that you see from a branded product. And if they do so, can they realize the (market share) that they need to invest in future biosimilars and continue in this marketplace,” he said.

The FDA labels biosimilars as interchangeable based on the results of “switching studies” of patients who go back and forth between taking the brand-name reference produce and the biosimilar with no loss of efficacy or safety. Depending on state-level pharmacy laws and regulations, interchangeability means a biosimilar can be dispensed at the pharmacy level instead of Humira without the prescriber’s prior approval.

According to Pagnotta, all but a handful of states allow Humira to be swapped out for the biosimilar with an interchangeable designation; he called it “auto-substitution.” But he said most states require the prescriber to the notified after the substitution is made.

The notification requirements differ from state to state, Pagnotta said: “Some may mandate that has to be a phone call and speak to a person. Some might be an email. Some might be a fax, still. That's where the laws differ.”

Pagnotta said Boehringer Ingelheim’s marketing campaign for Cyltezo includes supplying its sales people with information about state laws that they can share with physicians and pharmacists.

“When our rep is talking to a doctor or pharmacist in (for example) Cleveland, they will give them all the interchangeability laws and the information that they need of what happens in Ohio, so that there's no confusion for the prescriber or the pharmacist, which ultimately will keep the patient informed on exactly what's happening, because we feel at the end of the day, that's the most important thing,” he said.