Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext)

Cohen, Stanley; Czeloth, Niklas; Lee, Eric; Klimiuk, Piotr Adrian; Peter, Nuala; Jayadeva, Girish

doi:10.1080/14712598.2019.1645114

Cited by 22 publications

(39 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…BI 695501 was approved by the EMA and FDA in 2017. Previous research has confirmed its similarity in structure, function, and PK to ADL (15,16).…”

Section: Bi 695501 (Cyltezo)mentioning

confidence: 72%

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Lin

et al. 2021

Front. Immunol.

View full text Add to dashboard Cite

Adalimumab, as a TNF inhibitor biologic for the treatment of rheumatoid arthritis, is one of the top-selling drugs worldwide. As its various patents have gradually expired, experiments on its biosimilars are constantly being implemented. In this review, we summarized clinical trials of seven biosimilars currently approved by the FDA and/or EMA for the treatment of rheumatoid arthritis, namely: ABP 501 (Amjevita/Amgevita/Solymbic), BI 695501 (Cyltezo), SB5 (Imraldi/Hadlima), GP2017 (Hyrimoz/Hefiya/Halimatoz), MSB11022 (Idacio), FKB327 (Hulio), and PF-06410293 (Abrilada). Overall, these biosimilars showed similar efficacy, safety, and immunogenicity to adalimumab. All biosimilar switching trials indicated that switching from adalimumab to a biosimilar does not have a significant impact on efficacy, safety, and immunogenicity.

show abstract

“…BI 695501 was approved by the EMA and FDA in 2017. Previous research has confirmed its similarity in structure, function, and PK to ADL (15,16).…”

Section: Bi 695501 (Cyltezo)mentioning

confidence: 72%

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Lin

et al. 2021

Front. Immunol.

View full text Add to dashboard Cite

show abstract

“…The treatment efficacy established in the main trial was maintained throughout the OLE, and no new safety signals were identified. No differences in efficacy, safety, or immunogenicity were seen among the treatment groups [20].…”

Section: Bi 695501mentioning

confidence: 89%

“…In a long-term OLE, patients who previously received BI 695501 for 48 weeks were assigned to a group (n = 225), patients who previously received adalimumab RP for 24 weeks and were switched to BI 695501 were assigned to another group (n = 102), and patients who previously received adalimumab RP for 48 weeks were assigned to a third group (n = 103). All patients received BI 695501 40 mg/0.8 ml solution every 2 weeks for up to 48 weeks (treatment duration 98 weeks) [20]. The treatment efficacy established in the main trial was maintained throughout the OLE, and no new safety signals were identified.…”

Section: Bi 695501mentioning

confidence: 99%

Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity

2020

View full text Add to dashboard Cite

Although treatment with biologic diseasemodifying antirheumatic drugs (bDMARDs) has significantly improved clinical outcomes in patients with rheumatoid arthritis (RA), many patients do not have access to these treatments. As cost-effective alternatives to their reference products (RPs), biosimilars provide an opportunity to increase access to bDMARDs. The European Medicines Agency and the US Food and Drug Administration have detailed pathways for the approval of biosimilars based on establishing the similarity of the biosimilar to the RP in terms of structure and function, pharmacokinetics (PK), efficacy, safety, and immunogenicity. A number of biosimilars of adalimumab, infliximab, etanercept, and rituximab RPs have been approved in the United States and/or European Union. This article is focused on the seven adalimumab biosimilars. A review of the data for the biosimilars FKB327, ABP 501, BI 695501, GP2017, MSB11022, PF-06410293, and SB5 confirm that these products are highly similar to the adalimumab RP with regard to structure, physicochemical and biological properties, PK, safety, immunogenicity, and efficacy in the treatment of RA and other chronic immune-mediated, inflammatory conditions. Data from several switching studies showed no changes in efficacy, safety, trough serum drug concentration, or immunogenicity between the biosimilars and their RP. Trial registration: ClinicalTrials.gov identifiers: NCT02260791,

show abstract

“…To date, the FDA has not considered any biosimilar as interchangeable. 45 Although several phase III RCTs or open label extension studies on switching from reference adalimumab to the respective biosimilars or multiple switching between groups showed comparable safety, efficacy and immunogenicity, 15,20,21,26 evidence on the nonmedical switching from reference adalimumab to the respective biosimilars in the real-world setting is limited and is mostly based on a few small-scale observational studies with a limited number of subjects, thus seemingly insufficient to recommend this switching procedure. Safety data from real-world practice are available only for SB5.…”

Section: Interchangeability With Reference Adalimumabmentioning

confidence: 99%

An Update Review of Biosimilars of Adalimumab in Psoriasis – Bioequivalence and Interchangeability

Xin¹,

Chen²,

Bi³

2021

DDDT

View full text Add to dashboard Cite

Biologic drugs have revolutionized the treatment of psoriasis and other rheumatological diseases. In recent years, many biosimilar agents that are highly similar in structure and function to their originator products have been developed, including the tumor necrosis factor-alpha antagonist adalimumab. The considerably lower cost of these products has greatly cut the economic burden of the patients and increased the accessibility of biologic therapies worldwide. The US Food and Drug Administration and/or the European Medicines Agency have approved eight biosimilars of adalimumab (ABP 501/BI 695501/SB5/GP2017/ FKB327/MSB11022/PF-06410293/CT-P17) for the treatment of psoriasis, and others are under review. Given that these agents showed pharmacokinetic, efficacy, safety, and immunogenicity profiles comparable to those of the originator, adalimumab biosimilars were licensed for all indications approved for reference adalimumab based on extrapolation; however, some of the equivalence studies were only conducted in one or two disease populations. This review discusses the bioequivalence of adalimumab biosimilars as demonstrated by various clinical trials, the extrapolation of indications, guidance and policies of the EU and US on interchangeability (nonmedical switching/automatic substitution) between biosimilars and originators, and the real-life practices of switching from reference adalimumab to the respective biosimilars. Further data from real-world studies and post-marketing analyses are needed better to address the efficacy and safety of the transition strategy.

show abstract

Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext)

Cited by 22 publications

References 20 publications

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity

An Update Review of Biosimilars of Adalimumab in Psoriasis – Bioequivalence and Interchangeability

Contact Info

Product

Resources

About