Biosimilars Rheumatology Roundup: April 2023

In April, biosimilars to treat rheumatic conditions had some progress, as well as some setbacks, and research showed that switching from originators to biosimilars is safe and effective but warned about the nocebo effect.

Regulatory Updates

The European Commission granted marketing authorization for a citrate-free, high-concentration (HCF) version of Sandoz’ Hyrimoz, an adalimumab biosimilar referencing Humira. The HCF formulation allows for patients to receive treatment with a reduced injection volume and less injection site pain compared with the original, low-concentration version.

Hyrimoz HCF will be used to treat patients with rheumatoid arthritis, Crohn disease, ulcerative colitis, plaque psoriasis, uveitis, and hidradenitis suppurativa.

In the United States, the FDA issued a second complete response letter to Alvotech for its adalimumab candidate (AVT02), citing issues with its Iceland-based manufacturing facility.

The FDA conveyed that the manufacturing still exhibited some “deficiencies,” but no issues with the biosimilar product itself, including data regarding safety or efficacy, were found. Alvotech provided the FDA with responses to the agency’s inspection observations and is now waiting for a reply. Alvotech said that it will comply with the agency’s requests and that it still plans to pursue FDA approval. The FDA’s new decision date is set for June 28, 2023.

Switching Results

A study found that multiple switches between infliximab products appeared to be safe and effective in patients with inflammatory bowel disease (IBD). The study concerned Celltrion Healthcare’s product (Remsima), Samsung Bioepis’ biosimilar (Flixabi, Renflexis), and the originator (Remicade).

Inflixmab products are used to treat IBD, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis.

Another study examining nonmedical switching found that worsening patient-reported outcomes (PROs) after switching from Humira to an adalimumab biosimilar could likely be attributed to the nocebo effect, emphasizing the importance for better communication between physicians and patients to ensure that patients’ negative perceptions of biosimilars do not result in worsening PROs.

Industry Analyses

In the aftermath of the US launch of the first adalimumab biosimilar, Spherix Global Insights reported that although rheumatologists, dermatologists, and gastroenterologists rated their awareness of adalimumab biosimilars as high, a significant proportion of each group reported that they were not confident prescribing a biosimilar over the originator.

Despite comfort being lower than expected, providers expressed that they would be likely to prescribe a biosimilar. Additionally, most providers said that they were comfortable with adalimumab biosimilars having extrapolated indications and interchangeability designations.

In an episode of Not So Different, The Center for Biosimilars^® talked to Robert Zutaut, RPh, clinical specialist with McKesson Provider Solutions, about the influx of biosimilars of biosimilar to treat rheumatoid arthritis expected to enter the US market throughout 2023 and 2024 as well as actions that clinicians can take to prepare.

A study in BioDrugs found certain factors may influence a commercial health plan’s likelihood of placing coverage restrictions on biosimilars, citing that biosimilars that are cancer therapies, used to treat children, indicated for highly prevalent conditions, or only competing against the originator were more likely to have coverage restrictions.

The results are likely to apply to some rheumatology biosimilars, as rheumatoid arthritis affects around 1.3 million Americans, and up to 3.6 million Americans have psoriatic arthritis.