Kristine Kucera, PA-C, MPAS, DHS
The first interchangeable biosimilar for AbbVie’s Humira (adalimumab) officially entered the US market this month. Cyltezo (adalimumab-adbm) from Boehringer Ingelheim is now commercially available.
As a reminder, biosimilars are highly similar versions of biologic drugs that have already been approved. Clinical trials proved comparable efficacy and safety profiles to the originator molecule and formulation. (See my previous post on biosimilars here.)
The approval of interchangeable biosimilars is a rigorous process that involves demonstrating no clinically meaningful differences in safety, efficacy, and immunogenicity when compared to the reference product. This process requires data from a “switching study,” which shows multiple substitutions in patients with no increased risk. Cyltezo met these requirements and was granted interchangeable status by regulatory authorities.
Also now available in the U.S. is Hulio (adalimumab-fkjp) injection, a biosimilar to Humira, from Biocon Biologics Ltd, a subsidiary of Biocon Ltd.
Due to the nature of the process by which biologic treatments are developed, traditional assessments used to show “generic equivalence” of drugs do not apply. Therefore, a biosimilar is analogous to but not precisely the same as a generic. While the availability of biosimilars may offer patients an affordable alternative, drugs designated as interchangeable can be swapped at the pharmacy in place of the reference product, or other biosimilar, without consulting the prescribing physician, PA or NP.
It is important to be aware of these agents because I have had several patients ask about “Biosimilars.”
If you are interested in learning more about biosimilars, consider registering for the Dermalorian webinar on Wednesday, July 19 , 2023 at 8:30 pm ET.
Also, Dr. April Armstrong will present on biosimilars at DERM2023, next month in Las Vegas.
Kristine Kucera, PA-C, MPAS, DHS, is Assistant Clinical Professor, University of Texas Southwestern, Medical Center PA Program, Dallas, TX. She is a member of the DEF Advisory Council.
Reference:
https://www.healio.com/news/rheumatology/20230703/cyltezo-launches-as-first-interchangeable-humira-biosimilar?utm_source=selligent&utm_medium=email&utm_campaign=news&M_BT=3471561117904
Did You Know?
A biosimilar is a biologic that is highly similar to, and has no clinically meaningful differences from, another biologic that’s already FDA-approved (referred to as the reference product or original biologic). This means biosimilars have the same:
- Route of administration.
- Strength and dosage form.
- Potential side effects.
Biosimilars are intended to provide the same potential treatment benefits as the original biologic and are generally made with the same types of natural sources as the reference product.
An interchangeable biosimilar product is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.
An interchangeable biosimilar product may be substituted without the intervention of the health care professional who prescribed the reference product, similar to the processes by which generic drugs are substituted for brand name drugs.