Over the course of May, the immunology biosimilar space bloomed, with a European approval, a delay for ustekinumab biosimilars, more clinical trial updates, and insights into the industry from multiple immunology experts.
Over the course of May, the immunology biosimilar space bloomed, with a European approval, a delay for ustekinumab biosimilars, more clinical trial updates, and insights into the industry from multiple immunology experts.
An Approval, a Launch, and a Delay
The FDA approved Celltrion Healthcare’s Yuflyma, making it the ninth biosimilar referencing Humira (adalimumab) to receive regulatory approval in the United States. The biosimilar will be used to treat 8 indications, including rheumatoid arthritis, inflammatory bowel disease, and plaque psoriasis. Of the 9 FDA-approved products, Yuflyma is one of the only high-concentration adalimumab biosimilars expected to launch in July 2023.
In other Celltrion news, the company launched its infliximab biobetter that allows for subcutaneous administration (Remsima SC) in Brazil. Remsima SC is the only infliximab product in the world that can be delivered subcutaneously and is unique as a biobetter because it is an improvement to a biosimilar rather than an originator product. The product will be used to treat inflammatory bowel disease, an umbrella term for Crohn disease and ulcerative colitis.
On the legal side, Johnson & Johnson, the maker of Stelara (ustekinumab), settled its lawsuit against Amgen that claimed the latter infringed its manufacturing patents when developing a proposed ustekinumab biosimilar for the treatment of autoimmune conditions. Although most of the settlement terms were kept confidential, a key piece is that the proposed launch date for the biosimilar will be delayed from late 2023 to January 2025.
Immunology Industry Insights
In a series of interviews, The Center for Biosimilars®, the sister website of The American Journal of Managed Care®, talked to 2 coauthors of a journal supplement titled “Biosimilars for Immune-Mediated Inflammatory Diseases: 2022 Update.”
The first interview was a written Q&A with Colby Evans, MD, a dermatologist at Evans Dermatology Partners. In the interview, Evans focused on how the managed care industry views and has adapted to the influx of biosimilars to treat inflammatory conditions. He shared tips on how managed care organizations can work with health care providers, patients, and other stakeholders to better integrate biosimilars into immunology treatment practices and lessons that organizations can take away from other countries with more experience with these products.
The second interview was a podcast episode, where Vibeke Strand, MD, an adjunct clinical professor in the Division of Immunology/Rheumatology at Stanford University School of Medicine, dived into how health systems can take action and boost adoption of immunology biosimilars, including improving communication between providers and patients as well as enhancing pharmacovigilance reporting.
Additionally, Samsung Bioepis put out the first edition of its Biosimilar Market Report, in which the company outlined the current state of the US biosimilars market and how increasing adoption has had an impact on pricing changes for biosimilars and their reference products.
Clinical Trial Updates
Alvotech initiated a confirmatory study for its biosimilar candidate referencing Simponi and Simponi Aria (golimumab). The study will compare the safety, efficacy, and immunogenicity profiles through 16 weeks between the biosimilar and reference product in patients with moderate to severe rheumatoid arthritis.
A phase 1 study in China evaluating a tocilizumab biosimilar (LZM008) and the originator (Actemra) found similar pharmacokinetic profiles between the 2 drugs in health participants. Tocilizumab is a recombinant humanized monoclonal antibody to the IL-6 receptor used to treat rheumatoid arthritis.
Lastly, a real-world analysis found that Sandoz’ rituximab biosimilar GP2013 was safe and effective in patients with rheumatoid arthritis after switching from the originator (Rituxan). It’s the first real-world study on effectiveness of the biosimilar. The researchers evaluated GP2013 in both rituximab-naïve patients and patients who underwent a mandatory switch in Norway.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Cost and Efficacy Insights on Infliximab Biosimilars in Pediatric Uveitis
December 3rd 2024The study highlights the safety, efficacy, and cost benefits of infliximab biosimilars in managing pediatric noninfectious uveitis, showing fewer disease flares and reduced costs compared with reference infliximab, as well as the influence of insurance mandates on treatment decisions.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.