Biosimilars Gastroenterology Roundup: November 2024

In November 2024, Skyrizi surpassed Humira as AbbVie's top seller, while calls for PBM transparency and biosimilar access reforms grew. Meanwhile, Celltrion expanded its portfolio and Global Biosimilars Week focused on improving affordability and equity.

Market Insights

Skyrizi (risankizumab-rzaa) has officially dethroned Humira (reference adalimumab) as AbbVie’s top seller, less than 2 years after adalimumab biosimilars hit the US market.¹ Despite a sharp rise in adalimumab biosimilar use, the overall market for adalimumab has shrunk, thanks to AbbVie shifting patients from one of its drugs to another to maintain market share—a strategy often criticized as "product hopping." Industry leaders and policy makers are calling for transparency in pharmacy benefit manager (PBM) practices and legislative action to ensure biosimilars can compete fairly, helping patients access affordable treatments without stifling innovation.

In a recent report, Celltrion said it aims to commercialize 22 biosimilars by 2030, including 12 immunology and 7 oncology products.² Currently, it markets 6 biosimilars in the US, such as infliximab (Inflectra) and adalimumab (Yuflyma), along with Zymfentra, a novel subcutaneous infliximab formulation. As it merges with Celltrion Healthcare, the company is expanding production capacity and strengthening its position as a global leader in biosimilars and innovative therapies.

A recent review discussed the rising prevalence of inflammatory bowel disease (IBD) in Europe and North America and its growing financial burden on health care systems.³ The review highlighted challenges like disparities in access and underinsurance, and recommended strategies to reduce costs, including early biologic use, biosimilars, and improved patient monitoring. It also noted that patent thickets and reimbursement issues in the US have hindered biosimilar uptake.

Clinical Data in Gastroenterology Conditions

A phase 2 study found that adding the anti-HER2 antibody HLX22 to the trastuzumab biosimilar HLX02 and chemotherapy significantly prolonged progression-free survival (PFS) in HER2-positive advanced gastric cancer.⁴ The higher-dose HLX22 group had a median PFS of 15.1 months, compared with 8.2 months in the placebo group. Despite common adverse events, the combination showed manageable safety and enhanced tumor response, supporting the clinical benefits of dual HER2 blockade in this patient population.

In 2 trials, subcutaneous infliximab biosimilar CT-P13 (Zymfentra) showed superior efficacy to placebo in maintaining remission for Crohn disease and ulcerative colitis.⁵ CT-P13 resulted in higher clinical and endoscopic response rates and was well-tolerated, with no new safety concerns.

A review on tumor necrosis factor (TNF)–α inhibitors in IBD discussed the use of anti-TNF originators and biosimilars, their efficacy, safety, and challenges.⁶ The authors highlighted the cost benefits of biosimilars, noting that they could save billions in health care costs, improve patient access, and offer more treatment options. However, barriers include patent protections, market entry issues, reimbursement policies, and physician/patient reluctance.

Global Biosimilars Week

As a media partner for this year’s Global Biosimilars Week, an annual campaign created by the International Generics and Biosimilars Association (IGBA) designed to raise global awareness about biosimilar medicines, The Center for Biosimilars^® created several pieces of content centered around this year’s theme: advancing access to biosimilars.

This 3-part article series for Global Biosimilars Week 2024, examined key barriers to biosimilar access in the US:

• Part 1 addressed legal challenges, including the patent system and legislative efforts to overcome them.⁷
• Part 2 explored the complexities of payer and PBM policies, their impact on access, and potential changes under a second Trump term.⁸
• Part 3, authored by Dracey Poore of Cardinal Health, focused on interchangeability and its influence on biosimilar adoption and accessibility. The series highlights critical obstacles and proposes strategies to enhance biosimilar affordability and equity.⁹

Additionally, The Center for Biosimilars hosted a webinar, in partnership with IGBA, featuring a discussion on how to streamline regulatory requirements to advance biosimilar access.¹⁰ The webinar featured representatives from the FDA, World Health Organization, Medicines for Europe, the Saudi Food and Drug Authority, and the Association for Accessible Medicines (AAM) engaging in a discussion on global regulatory trends and strategies to address biosimilar accessibility challenges.

Lastly, a special podcast episode of Not So Different starred Craig Burton, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at AAM, who talked about whether certain regulatory policies to boost biosimilar adoption in other countries could work in the US.¹¹

References

1. Jeremias S. Skyrizi overtakes Humira: “product hopping” leaves biosimilar market in limbo. The Center for Biosimilars. November 7, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/skyrizi-overtakes-humira-product-hopping-leaves-biosimilar-market-in-limbo

2. Jeremias S. Celltrion sets sights on 2030 with expanded biosimilar portfolio, market reach. The Center for Biosimilars. November 6, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/celltrion-sets-sights-on-2030-with-expanded-biosimilar-portfolio-market-reach

3. Ferreri D. Making the cost of IBD care sustainable. The Center for Biosimilars. November 2, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/making-the-cost-of-ibd-care-sustainable

4. Ferreri D. Achieving PFS in advanced gastric cancer with HLX02 biosimilar, chemotherapy. The Center for Biosimilars. November 23, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/achieving-pfs-in-advanced-gastric-cancer-with-hlx02-biosimilar-chemotherapy

5. Ferreri D. Subcutaneous infliximab CT-P13 superior to placebo as maintenance therapy for IBD. The Center for Biosimilars. November 16, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/subcutaneous-infliximab-ct-p13-superior-to-placebo-as-maintenance-therapy-for-ibd

6. Ferreri D. Challenges, obstacles, and future directions for anti-TNF biosimilars in IBD. The Center for Biosimilars.November 9, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/challenges-obstacles-and-future-directions-for-anti-tnf-biosimilars-in-ibd

7. Jeremias S. Breaking down biosimilar barriers: the patent system.The Center for Biosimilars. November 11, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system

8. Jeremias S. Breaking down biosimilar barriers: payer and PBM policies. The Center for Biosimilars. November 13, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-payer-and-pbm-policies

9. Poore D. Breaking down biosimilar barriers: interchangeability. The Center for Biosimilars. November 14, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-interchangeability

10. The Center for Biosimilars Staff. Webinar: streamlining the regulatory process to advance access to biosimilars. The Center for Biosimilars. November 21, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/webinar-streamlining-the-regulatory-process-to-advance-access-to-biosimilars

11. Jeremias S. Can global policies to boost biosimilar adoption work in the US? The Center for Biosimilars. November 17, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/can-global-policies-to-boost-biosimilar-adoption-work-in-the-us-