Biosimilars/Research

Prices for arthritis biologicals in Latin America

Biosimilars/Research | Posted 21/06/2021

Analysis of the prices of biological and biosimilar drugs used to treat rheumatoid arthritis suggests these drugs are more accessible in Spain than in Latin America, but least affordable in the US [1].

New data on adalimumab biosimilars from Samsung Bioepis and Boehringer Ingelheim

Biosimilars/Research | Posted 21/06/2021

Recently published data show that switching to Samsung Bioepis adalimumab
biosimilar Imraldi is safe and effective, while data from Boehringer Ingelheim suggest their adalimumab biosimilar, Cyltezo, could be classed as interchangeable.

Positive phase III results for tocilizumab biosimilar BAT1806

Biosimilars/Research | Posted 11/06/2021

US biotechnology company Biogen Idec (Biogen) and China-based Bio-Thera announced on 1 June 2021 positive phase III data for their tocilizumab biosimilar, BAT1806. According to the two companies, ‘the comparative study met its primary endpoints and showed equivalent efficacy and comparable safety profile in patients with moderate-to-severe rheumatoid arthritis’.

Efficacy and safety of Yuflyma vs reference adalimumab in rheumatoid arthritis

Biosimilars/Research | Posted 11/06/2021

Yuflyma (CT-P17) is an adalimumab biosimilar, administered at 100 mg/mL that also has the same citrate-free and high concentration formulation of reference adalimumab. To demonstrate the bioequivalence of CT P17 to reference adalimumab, a randomized, double-blind, active-controlled study in subjects with moderate to severe rheumatoid arthritis (RA) was conducted [1]. The study was designed to demonstrate equivalence of efficacy (ACR20* response rate at Week 24) for CT P17 versus reference adalimumab and to evaluate additional efficacy, pharmacokinetics (PK), usability and safety over one year.

Positive phase I results for Meiji’s ustekinumab biosimilar

Biosimilars/Research | Posted 04/06/2021

Japan-based Meiji Seika Pharma (Meiji) announced on 21 May 2021 positive phase I results for its candidate ustekinumab biosimilar, DMB-3115.

Review and meta-analysis of biosimilars for the treatment of rheumatoid arthritis

Biosimilars/Research | Posted 04/06/2021

Authors from Japan provide a new perspective on biosimilars for management of rheumatoid arthritis (RA) to provide evidence of efficacy and safety of biosimilars compared with reference biological disease-modifying anti-rheumatic drugs (bDMARDs) (reference bDMARDs) in patients with RA as a part of the process of developing the 2020 update of the Japan College of Rheumatology (JCR) guidelines for the management of RA [1].

On the edge of transition: European biosimilar clinical trial requirements

Biosimilars/Research | Posted 31/05/2021

Recent debates have focused on the clinical trial requirements for biosimilar approval [1-4]. Further, the regulatory approval of biosimilars in the European Union (EU) has been changed, where in some instances and under certain conditions clinical trials to establish comparable efficacy have been excluded [4]. Still, the regulatory recommendation for more complex molecules such as monoclonal antibodies is without exception to conduct clinical comparability trials [4].

Are regulatory and scientific reporting biosimilar QAs consistent and complimentary?

Biosimilars/Research | Posted 21/05/2021

Questions have been raised regarding the consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities. For the first time, a study published in Biologicals [1] has found that while the reporting of quality attributes (QAs) by these two sources lacks consistency, overall, they do complement one another. 

Role of European patient associations when informing patients about biosimilars

Biosimilars/Research | Posted 21/05/2021

Biosimilars contribute to more sustainable healthcare systems by generating competition in the off-patent biologicals market. The extent to which the benefits of competition in the marketplace are exploited depends, of course, on their use in clinical practice. One of the factors determining adoption in clinical practice is the acceptance by healthcare providers (HCP) and patients. Often, a lack of acceptance comes down to shortcomings in knowledge and understanding about biosimilars. Educating patients about biosimilars is therefore considered as one of the key elements for a successful market for off-patent biologicals and biosimilars.

Biosimilars for skin conditions safe and effective

Biosimilars/Research | Posted 14/05/2021

Two recently published articles [1, 2] assessing the use of biosimilars for the long-term skin conditions psoriasis and hidradenitis suppurativa indicate that biosimilar treatments are equally as effective as the originator, demonstrating similar drug retention and clinical response rates, respectively.