Biosimilars Gastroenterology Roundup: May 2024

May proved to be a big month for biosimilar research, particularly in the gastroenterology space, where new data on infliximab and adalimumab products from conferences and journals alike demonstrated positive clinical results showcasing the safety of these products as well as switching to them.

Business News

At the beginning of the month, the FDA approved a high-concentration, citrate-free version of Boehringer Ingelheim's Cyltezo (adalimumab-adbm). The low-concentration version of the biosimilar, which references Humira (adalimumab), was originally approved August 2017 and was the first adalimumab biosimilar to receive an interchangeability designation; however, only the low-concentration version has been deemed interchangeable. The new formulation marks the fifth high-concentration adalimumab biosimilar product to be approved.

In other business updates, Teva and Alvotech launched Simlandi, another interchangeable adalimumab biosimilar, in the US, aiming to provide a cost-effective alternative to Humira. Xbrane Biopharma and STADA Arzneimittel, in partnership with Valorum Biologics, are set to introduce a ranibizumab biosimilar, targeting treatments for eye conditions.

Additionally, Celltrion and Boehringer Ingelheim are expanding access to their adalimumab biosimilars through significant discounts and new distribution partnerships. The companies said that their respective developments are expected to lower health care costs and improve patient access to these important medications.

Digestive Disease Week 2024 Posters

Several posters from Digestive Disease Week 2024 presented new data confirming the safety of infliximab biosimilars as well as Zymfentra, a subcutaneous infliximab product based on Celltrion's infliximab biosimilar (Inflectra).

Two posters evaluated the safety and efficacy of Zymfentra and the impact of body mass index (BMI) on clinical outcomes associated with the use of the product in patients with inflammatory bowel disease (IBD). Key findings indicated that Zymfentra is effective and well tolerated, with BMI not significantly affecting its efficacy. The insights support Zymfentra as a viable treatment option for IBD, contributing to broader biosimilar adoption in clinical practice.

More posters looked at the safety of switching patients using infliximab biosimilars. The first study evaluated switching in pediatric patients and the second looked at real-world data supporting the safety of switching between multiple infliximab biosimilars. Both analyses demonstrated positive results, which should help reassure patients, caregivers, and providers of the safety of these products.

Additionally, abstracts from the Academy of Managed Care Pharmacy annual meeting offered hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator. One study confirmed that low-concentration Cyltezo has comparable safety, efficacy, and immunogenicity to Humira, based on the VOLTAIRE studies involving patients with rheumatoid arthritis, Crohn disease, and psoriasis. No significant differences were found in adverse events or serious health issues. Another study showed that a 2% uptake of Hadlima (adalimumab-bwwd) could save $25.3 million annually for a 1 million-member US plan due to its lower cost compared with Humira.

More Research on Adalimumab and Infliximab Biosimilars

A recent article discussed new evidence that confirmed the safety of switching from one biosimilar to another biosimilar, highlighting their potential to provide cost-effective alternatives while maintaining patient well-being. Switching between infliximab and adalimumab biosimilars was effective and generally well tolerated. In sarcoidosis, no issues were observed within 6 months of switching. In IBD, there was a 9.4% discontinuation rate, with one switch due to immunogenicity.

Another article discussed a real-world study from Spain that evaluated the safety and effectiveness of the adalimumab biosimilar MSB11022 in patients with IBD. The study found that MSB11022 was safe and effective, with patients experiencing similar outcomes and adverse events compared with the originator drug. These findings support the use of MSB11022 as a viable alternative for IBD treatment, highlighting its potential for cost savings and increased access to biologic therapies for patients.

One study evaluated Canadian patients with IBD who were switched to a biosimilar as part of a mandatory switch program. The study found that these patients did not experience a "nocebo" effect, meaning they did not report increased symptoms or negative effects after the switch. This suggested that mandatory switches to biosimilars in patients with IBD could be done without causing undue concerns or worsening of symptoms, supporting the broader adoption of biosimilars in IBD treatment.

Lastly, an article reviewed product attributes relevant to injection site pain during adalimumab treatment. It examined factors such as formulation, device design, and patient characteristics that could influence injection site pain. The review aimed to provide insights into strategies for minimizing discomfort associated with adalimumab injections.