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Top 5 Biosimilar Articles of 2024
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The top 5 biosimilar articles touch on the growing biosimilar landscape, including recent FDA approvals, patent disputes, cost-saving potential, and challenges in market entry.
The top 5 biosimilar articles touch on the growing biosimilar landscape, including recent FDA approvals, patent disputes, cost-saving potential, and challenges in market entry. | Image Credit: Shutter2U- stock.adobe.com
These articles reflect growing trends of biosimilar development and their potential impacts on health care costs and patient access.
Here are the top 5 most-read biosimilar articles in 2024.
5. FDA Approves Imuldosa, a Fifth Biosimilar to Stelara
The FDA has approved Imuldosa, a biosimilar to Stelara, for treating autoimmune diseases like plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Stelara, a top-selling biologic, generated over $10 billion globally in 2023. Imuldosa was jointly developed by Dong-A ST and Meiji Seika Pharma. This is Dong-A ST's second FDA approval, following Sivextro in 2014, and 1 of 3 biosimilars currently in development.
4. Budget Impact Analysis of Biosimilar Natalizumab in the US
Biosimilars offer a more cost-effective treatment for multiple sclerosis (MS). This study evaluated the potential savings from switching to biosimilar natalizumab (NTZ) in the US commercial payer market. Over 3 years, 255 patients were estimated to be treated with high-efficacy MS therapies. Including biosimilar NTZ on formularies could save payers $452,611, with mean savings per treated member per year ranging from $1,179 to $2,359. Sensitivity analyses showed that drug acquisition costs were most influential on budget impact. Adopting biosimilar NTZ can significantly reduce costs for US health plans, potentially increasing treatment access for MS patients.
3. CareFirst Files Lawsuit Against J&J Over Delay Tactics for Stelara Biosimilars
Wezlana, the first Ustekinumab (Stelara) biosimilar, is delayed by over a year despite FDA approval. CareFirst BlueCross BlueShield sued Johnson & Johnson for patent fraud, alleging it delayed biosimilar competition. CMS included Stelara on its list of 10 drugs for Medicare price negotiation, but negotiated prices won't take effect until 2026. Even with interchangeability designation, Wezlana's launch is delayed until 2025 due to a settlement with J&J.
2. Navigating the Biosimilar Frontier: Opportunities and Challenges in 2024
Biosimilars hold the potential to revolutionize health care by offering more affordable and accessible treatments. While gaining traction, better understanding from payers and providers is crucial for realizing their full potential in the US. In the past 2 years alone, over 10 biosimilars have received FDA approval, with a growing focus on autoimmune diseases. Collaboration between pharmaceutical companies, regulatory bodies, and health care providers will be key in shaping the future of biosimilars, requiring refined regulatory frameworks and increased education to build trust and facilitate their seamless integration into standard treatments.
1. FDA Approves First 2 Denosumab Biosimilars
Sandoz has launched Wyost and Jubbonti (denosumab-bddz), interchangeable biosimilars to Amgen's Xgeva and Prolia. However, these approvals come with safety warnings and a Risk Evaluation and Mitigation Strategy program for Jubbonti. Additionally, there is ongoing litigation between Sandoz and Amgen, with the reference product maker alleging patent infringement. One of the patents in question doesn't expire until 2037.
