Biosimilars/Research

Regulatory challenges with biosimilars

Biosimilars/Research | Posted 08/01/2021

The World Health Organization (WHO) Expert Committee on Biological Standardization adopted guidelines for biosimilars at its 60th meeting in October 2009 [1]. Since then, according to authors from regulatory bodies across the globe, WHO ‘has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices’.

Local level biosimilar prescribing proactivity revealed in Italy

Biosimilars/Research | Posted 25/06/2021

Italian local healthcare authorities are highly proactive regarding actions on prescribing behaviour for off-patent biologicals, reveals a study published in GaBI Journal [1]. However, work needs to be done to appropriately reallocate resources gained through patent expiration.

Measures to promote the use of biosimilars

Biosimilars/Research | Posted 25/06/2021

How to increase the uptake of biosimilars is an important issue both in Europe and across the world. Europe, via its centralized European Medicines Agency (EMA), has been very successful in approving biosimilars. There are currently 73 biosimilars approved in Europe, almost all of which were marketed immediately after approval [1]. Despite the success in approving and marketing biosimilars, the uptake of biosimilars does vary between different countries in Europe. To encourage the use of biosimilars, targets and incentives have been used across Europe [2]. However, pricing can also play an important role and was investigated by Josep Maria Guiu Segura and Antoni Gilabert Perramon [3].

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].