Cyltezo approved as interchangeable biosimilar with Humira

Regulatory NewsRegulatory News | 18 October 2021 |  By 

An anti-inflammatory biosimilar from Boehringer-Ingelheim has received interchangeability designation from the US Food and Drug Administration (FDA).     
Cyltezo (adalimumab-adbm) is now both biosimilar to and interchangeable with Abbvie’s Humira (adalimumab), announced FDA, which had granted biosimilar status to Cyltezo in 2017. Cyltezo is approved for all indications for which Humira can be used, including several inflammatory arthritides, Crohn’s disease and ulcerative colitis, and plaque psoriasis.
Interchangeable biosimilars may be substituted at the pharmacy level, without prescriber intervention, in the same way that generic drugs may be substituted for their name-brand counterparts. An interchangeable biosimilar is judged by FDA to be “highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA,” according to FDA’s announcement of its decision.
The Cyltezo approval marks the first interchangeability designation for an anti-inflammatory biologic and the second interchangeable approval from FDA. Semglee (insulin glargine-yfgn) received the agency’s first such nod in January, when FDA designated the Mylan product interchangeable with Sanofi’s Lantus (insulin glargine). Insulin prices have been climbing over the past decade in the US, creating a care crisis for many of the 34 million US residents who have type 1 or type 2 diabetes.
“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” said acting FDA commissioner Janet Woodcock in the announcement. “We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective.”
Though biosimilarity and interchangeability designations are seen as tools to help reduce the cost of biologics therapy in the US, biosimilar uptake has been slow to date. A host of regulatory and market forces, ranging from “patent thickets” credited by marketers of originator biologics to low prescriber and patient awareness of the relationship between biosimilars and originator biologics, have been factors contributing to still-high biologics prices in the US.
However, there are clues some inroads are being seen: According to, the per-unit cash price for Semglee was $11.25 on 18 October, compared with $30.55 per unit for Lantus.
A recent study led by staff at FDA and the US Department of Health and Human Services (HHS) found lingering knowledge gaps among medical professionals across several specialties regarding how biosimilars are related to their reference products.
When drug formularies include biologics, prescribers are more likely to give them to patients, but lagging “confidence in pharmacovigilance” and the need for “education on FDA approval processes” also factored into medical professionals’ reluctance to turn to biosimilars, according to the study led by Allison Kolbe of HHS and published in BioDrugs.  (RELATED: Insurance, physician barriers impede wider adoption of biosimilarsRegulatory Focus 12 April 2021)
Potential savings for higher biosimilar adoption could be substantial, according to a recent report prepared by the Biosimilars Forum in conjunction with the Pacific Research Institute. An overall US biosimilar market share of 75% would result in annual savings of over $14 billion, according to the report, which includes an “interactive savings tool” that shows savings per state if biosimilar adoption were to hit the 75% mark.
“By increasing biosimilar competition, states stand to save billions if policymakers enacted simple reforms to foster a more robust biosimilars market,” said Meaghan R. Smith, executive director of the Biosimilars Forum in an announcement following FDA’s Cyltezo designation. “Increasing biosimilar use among physicians and patients will require a commitment from our lawmakers to remove the anti-competitive barriers to biosimilar uptake and minimize disincentives. Without competition from biosimilars, the cost of biologics will continue to increase and limit access to treatment for patients.”


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