Humira (adalimumab) is a biologic medicine used to treat several autoimmune diseases like rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis and others. Since its approval in 2002, Humira has dominated the autoimmune therapeutics market. However, its patent expired in late 2023, opening the door for biosimilar versions.
Humira biosimilars offer a more affordable alternative for patients needing Humira therapy. They are developed to be highly similar to the original biologic with no clinically meaningful differences in efficacy, safety or immunogenicity. This article provides an overview of Humira biosimilars currently available or in development.
Biosimilars Approved in the US
Hadlima (adalimumab-bwwd) was the first Humira Biosimilar approved by the FDA in April 2022. It is manufactured by Samsung Bioepis and marketed by Celltrion in the US. Hadlima has the same dosage strengths and administration as Humira, as an injection under the skin.
In June 2022, the FDA approved Hyrimoz (adalimumab-adaz) and Cyltezo (adalimumab-adbm) for the same approved indications as Humira. Hyrimoz is made by Boehringer Ingelheim and Cyltezo by Sandoz. Both offer a more affordable treatment option without substituting efficacy or safety.
The FDA approved Abrilada (adalimumab-afzb), an Humira biosimilar from Amgen, in September 2022. It contains the same active ingredient and works in a similar way as Humira but costs less. Abrilada received approval for all Humira indications like rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.
Other Humira Biosimilars in Development
In addition to the approved biosimilars, several other versions are in various stages of development and regulatory review in the US. Ziextenzo from Sandoz/Prati-Lapp received FDA approval in November 2022 and is the latest Humira biosimilar.
IDACIO is an adalimumab biosimilar being developed by Pfizer. It has been approved in Europe and is undergoing a phase 3 trial in the US evaluating its efficacy and safety compared to Humira in rheumatoid arthritis patients.
HBP-017 is the Humira biosimilar from Mylan/Biocon which has completed two studies showing equivalent efficacy, safety and immunogenicity to Humira. It is currently under regulatory review by the FDA.
BI 695501, the AbbVie/EpirusHumira biosimilar has completed two studies in rheumatoid arthritis and plaque psoriasis patients. It has been approved in EU and Canada but is yet to file for FDA approval in the US.
SB5 or adalimumab is in development by Samsung Bioepis. It has received approvals globally based on Phase I pharmacokinetic study and is expected to enter late stage trials in the US.
Therefore, by late 2023 or 2024, the US market is expected to see even more Humira biosimilar approvals, further driving down costs through competition while maintaining high quality of care.
Pricing and Cost Savings with Biosimilars
The introduction of biosimilars on the market has already resulted in substantial savings for patients as well as the overall healthcare system. According to studies, the approval of the first Humira biosimilar led to an immediate 15-20% reduction in the drug price set by AbbVie.
With the availability of multiple competitors, further price cuts are anticipated. A report by the Congressional Budget Office projected that increased use of Humira biosimilars could save $5-8 billion for Medicare over 10 years. Patients are also saving as most biosimilar makers offer their products at 30-50% lower list prices compared to Humira.
Co-pay levels for those with commercial insurance have also reduced to $25-$50 range depending on the plan design. For those without insurance, many biosimilar makers offer patient assistance programs and co-pay cards for completely free or low-cost prescriptions.