July 7, 2023 / By

The Arrival of Adalimumab Biosimilars: A New Era of Accessible Treatment for Autoimmune Diseases

The Arrival of Adalimumab Biosimilars: A New Era of Accessible Treatment for Autoimmune Diseases

After years of waiting and legal battles, the first wave of adalimumab biosimilars is finally making its way to the market in July 2023. Adalimumab, commonly known as Humira, is a widely used biologic medication for treating autoimmune diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. Biosimilars are highly similar versions of existing biologic drugs, offering a more affordable alternative for patients.

Let’s take a detailed look at each of the eight adalimumab biosimilars expected to launch:

1. Amgevita (Amgen): Developed by Amgen, Amgevita gained approval from the U.S. Food and Drug Administration (FDA) in 2022. It demonstrated similar safety, efficacy, and quality to Humira in clinical trials and is expected to offer a more affordable option for patients.

2. Cyltezo (Boehringer Ingelheim): Cyltezo is another biosimilar approved by the FDA in 2017. Boehringer Ingelheim developed this biosimilar, and its launch in July 2023 is expected to increase competition in the market, potentially driving down the cost of treatment.

3. Abrilada (Pfizer): Pfizer’s biosimilar, Abrilada, gained FDA approval in 2019. It showed comparable efficacy and safety to Humira in clinical studies. The launch of Abrilada is expected to provide more choices for patients while ensuring similar treatment outcomes.

4. Hefiya (Samsung Bioepis): Samsung Bioepis received FDA approval for Hefiya in 2020. This biosimilar demonstrated equivalence to Humira in terms of its safety and effectiveness. With Hefiya’s entry into the market, patients may have access to a more cost-effective treatment option.

5. Hyrimoz (Sandoz): Hyrimoz, developed by Sandoz, received FDA approval in 2019. This biosimilar demonstrated no clinically meaningful differences compared to Humira in terms of safety, efficacy, and quality. Hyrimoz’s launch aims to enhance patient access to treatment options at a reduced cost.

6. Hadlima (Samsung Bioepis): Hadlima gained FDA approval in 2019, offering another biosimilar option developed by Samsung Bioepis. Clinical trials demonstrated that Hadlima was highly similar to Humira, providing comparable therapeutic benefits. Its launch is expected to increase affordability and accessibility for patients.

7. Idacio (Fresenius Kabi): Fresenius Kabi’s Idacio received FDA approval in 2019. It demonstrated high similarity to Humira in terms of safety, efficacy, and quality. The introduction of Idacio to the market is expected to expand treatment possibilities and potentially alleviate financial burdens on patients.

8. Hulio (Mylan): Hulio, developed by Mylan, gained FDA approval in 2018. It exhibits a high degree of similarity to Humira and offers an alternative option at a potentially lower cost. The launch of Hulio is expected to promote competition and increase patient access to adalimumab treatment.

The entry of these eight adalimumab biosimilars into the market is likely to have a positive impact on patients by increasing competition, potentially resulting in reduced costs. As more biosimilar options become available, patients and healthcare providers will have a wider range of choices, fostering affordability and accessibility to this critical medication.