Biosimilars Immunology Roundup: May 2023

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.