Peter Page

Another study from Europe found that biosimilar etanercept was effective and well-tolerated in the majority of patients who switched from originator etanercept.

The study looked at Samsung Bioepis’ biosimilar, SB4, which is sold as Benepali in European countries. 

 have also found SB4 to work well for the majority of patients who switched from the originator etanercept, Enbrel. The anti-tumor necrosis factor (anti-TNF) inhibitor, is currently prescribed in the United States for rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis (PsA), ankylosing spondylitis, and plaque psoriasis.

An observational study conducted in Poland looked at patients being treated for RA, juvenile idiopathic arthritis, PsA, or ankylosing spondylitis, in which the originator etanercept replaced SB4.  

Etanercept was replaced with SB4 in 162 patients (Group 1), and in another 6 patients SB4 was the initial biologic used (Group 2). Efficacy and safety were assessed over a 6-month period.

The biosimilar was effective and well-tolerated in the majority of patients, however, for 24 patients in Group 1 (14.8%), returning to the originator was necessary due to loss of efficacy or adverse events.

Previous observational studies have found rates of discontinuing the biosimilar ranging from 2-14%. Specifically in this study:

9 patients experienced clinically confirmed loss of efficacy

9 patients reported subjective loss of efficacy

13 patients reported adverse events, the most common of which were headache and skin lesions.

Of the 24, returning to the originator reversed the loss of efficacy or resolved the adverse event. No adverse events were reported in the 6 patients for whom the biosimilar was the initial therapy (Group 2), and the biosimilar was effective in these patients.

The authors conclude that SB4 was effective and well-tolerated in most patients, but that further research is required to investigate the effects of switching patients between originators and biosimilars.

Felis-Giemza A, Chmurzy&#324;ska K, Na&#322;&#281;cz-Janik J, et al. Observational study of inflammatory arthritis treatment by etanercept originator switched to an etanercept biosimilar.

2019;57(5):257—263. doi:10.5114/reum.2019.89516.

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The study follows others that have found that SB4 works well for the majority of patients who switched from the originator etanercept, Enbrel.

Another European Study Finds SB4 Tolerated by Most Patients

Two studies recently reported on the adalimumab biosimilar marketed and developed by Mylan and its partner Fujifilm Kyowa Kirin Biologics, saying Hulio (named FKB327 during development) is equivalent to AbbVie’s blockbuster adalimumab (Humira) for treating rheumatoid arthritis, as well as having comparable bioavailability among delivery methods.

Adalimumab, an inhibitor of tumor necrosis factor alpha (TNF-&#593;), is typically prescribed for rheumatoid arthritis and additional conditions including psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

 of 24-week duration (Period I) followed by an open-label period (Period II) found FKB327 was equivalent to reference product Humira in clinical efficacy and demonstrated comparable safety and immunogenicity in patients with moderate-to-severe rheumatoid arthritis also taking methotrexate.

FKB327 contains adalimumab but includes different excipients. Preclinical studies showed FKB327 and originator adalimumab are comparable with respect to binding to the target antigens and for inducing apoptosis and cellular cytotoxicity. A subsequent phase 1 clinical study of FKB327 and adalimumab demonstrated comparable pharmacokinetic, safety, and immunogenicity profiles.

The primary endpoint of Period I was ACR20 (American College of Rheumatology) response rate. At 24 weeks of treatment, 74.1% of patients on FKB327 and 75.7% of patients on adalimumab showed an ACR20 response. ACR50 and ACR70 response rates were also similar in the 2 groups.

During the open-label phase of the study (Period II), patients were re-randomized, with two-thirds remaining on the same treatment and the other third switching treatments. No significant differences in ACR20, ACR50, ACR70 response rates were seen between the 4 drug sequence groups at 54 weeks or at interim points throughout Periods I and II. Immunogenicity and rates of adverse events were also comparable between groups.

 was an open-label study which assessed bioavailability of a single subcutaneous dose of FKB327 in 195 healthy subjects by 3 different delivery methods: prefilled syringe, auto-injector, and vial with disposable syringe. This study reported pharmacokinetic parameters, safety, immunogenicity were similar in the 3 delivery methods, suggesting these delivery methods could be used interchangeably in clinical practice.

In 2018, Humira accounted for 61% of AbbVie’s revenues, but that percentage began falling last year as adalimumab competitors in Europe, such as Hulio, took hold. In the United States, however, Humira will not face a biosimilar challenger until 2023.

1. Genovese MC, Glover J, Greenwald M, et al. FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension [published online December 12, 2019]. 

2. Bush J, Kawakami K, Muniz R. A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects [published online December 30, 2019]. 

Two studies recently reported on Hulio, the adalimumab biosimilar marketed and developed by Mylan and its partner Fujifilm Kyowa Kirin Biologics.

Peter Page

Another European Study Finds SB4 Tolerated by Most Patients

2 Studies Report on Biosimilar Adalimumab Hulio