FDA OKs BI’s Interchangeable Biosimilar of Humira

The US Food and Drug Administration has approved the first interchangeable biosimilar product to AbbVie’s blockbuster drug, Humira (adalimumab). Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product, Humira (adalimumab), for approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody.

Although the FDA has approved other biosimilars of AbbVie’s Humira, this is the first interchangeable biosimilar approval of the drug. The interchangeability designation potentially broadens the use of the drug. An interchangeable biosimilar product may be substituted for the reference product without the prescriber having to change the prescription. The substitution may occur at the pharmacy, subject to state pharmacy laws, which vary by states, a practice commonly called “pharmacy-level substitution,” similar to how generic drugs are substituted for brand name drugs. Biosimilars not designated as interchangeable require a prescription specifically for that biosimilar.

In July (July 2021), the FDA approved the first interchangeable biosimilar in the US, Semglee (insulin glargine-yfgn), from Viatris and Biocon Biologics, an interchangeable biosimilar of Sanofi’s Lantus (insulin glargine), a long-acting insulin to treat Type 1 and Type 2 diabetes.

Humira is AbbVie’s top-selling product and one of the industry’s top-selling products with 2020 global sales of $19.8 billion, with the US accounting for $16.0 billion in sales. Humira will lose exclusivity in the US in 2023. AbbVie has several patent settlements with companies, including BI, Amgen, Merck & Co./Samsung Bioepis, which allow the launch of those companies’ biosimilars of Humira in 2023. Although Cyltezo was approved as a biosimilar in August 2017, it is not scheduled to launch until July 2023 under the settlement agreement with AbbVie arising from Humira litigation.

Cyltezo is approved for the following indications in adult patients: moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and moderate-to-severe chronic plaque psoriasis. Cyltezo is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients two years of age and older, and pediatric patients six years of age or older with Crohn’s disease.

Source: The FDA