Biosimilars/Research

Definition of biological terms in Latin America

Biosimilars/Research | Posted 03/12/2021

To conduct a comparative study of the health registration regulations for biological and biotechnological drugs in Latin America, Ramírez-Telles et al. made an approximation, as clear as possible, of biological terms: regulatory authority of reference, biotechnological drug, reference biological drug and innovative product. Its objective was to detect the differences and what these variations entailed when comparing the following Latin American countries: Brazil, Chile, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras and Panama [1]. 

Evidence on automatic substitution of biologicals is limited

Biosimilars/Research | Posted 03/12/2021

A systematic review of the evidence on automatic substitution of biological medicines [1] finds that current research evidence is mainly based on opinion polls and surveys of low-to-moderate quality, with results that are not generalizable or suitable for guiding policy.

Biosimilar mAb development – quality similarity considerations

Biosimilars/Research | Posted 26/11/2021

Since 2013, when the first biosimilar monoclonal antibody (mAb) was approved by the European Medicines Agency (EMA), the number of approved biosimilar mAbs has been increasing dramatically [1]. The large number of approved biosimilar mAbs in both the European Union (EU) and the US makes the evaluation of these applications possible from a product quality perspective.

Advances for Samsung Bioepis’ eculizumab and trastuzumab biosimilars

Biosimilars/Research | Posted 26/11/2021

Samsung Bioepis has announced the completion of its global phase III clinical trials of a biosimilar of Soliris (eculizumab), for treating certain rare blood diseases. In addition, it also presented its results from a five-year follow-up study that showed its biosimilar Ontruzant (trastuzumab) has comparable cardiac safety profiles and long-term efficacy as the originator, Herceptin.

Regulation of the registration of biological drugs in Latin America

Biosimilars/Research | Posted 19/11/2021

Biological drugs are defined as products with active ingredients produced from a biological source, whereas a biotechnological product is developed from the isolation of a gene of interest and its cloning [1].

Biosimilars: Promises made. Promises kept?

Biosimilars/Research | Posted 19/11/2021

Biosimilars are biological products that are highly similar to their reference biologicals. Biosimilars are designed to have comparability with respect to quality, safety and efficacy compared to an already licensed reference biological. Most regulatory agencies, including the European Medicines Agency (EMA), do not require a full clinical dossier for a biosimilar. It is usually possible to carry out one clinical trial in one indication, with the option to extrapolate to other indications of the reference biological [1].

Progress in the regulation of biosimilars in the EU

Biosimilars/Research | Posted 12/11/2021

Analysis of regulation of biosimilars in the EU concludes that regulation is progressing as more knowledge is gained, which is reflected in the changing nature of regulatory guidelines. The authors conclude that the EU framework generates safe and effective biosimilars [1].

Biosimilars, clinical management and incentives

Biosimilars/Research | Posted 12/11/2021

The aim of a study carried out by Spanish researchers was to identify and analyse policies applied in the health services to enhance uptake of biosimilars in the framework of clinical management settings [1]. Incentives, both financial and non-financial, were of particular interest for the authors. They reviewed the relevant experiences developed in different high-income countries with advanced healthcare systems. In addition, they investigated barriers to the implementation of these policies in Spain.

YLB113 etanercept biosimilar autoinjector 'safe and effective’

Biosimilars/Research | Posted 05/11/2021

Analysis of the YLB113 etanercept autoinjector, a biosimilar to reference etanercept, finds a high rate of injection success and supports the safe and effective use of YLB113 [1].

Progress for bevacizumab copy biologicals from Henlius and Innovent

Biosimilars/Research | Posted 05/11/2021

Shanghai Henlius Biotech, Inc (Henlius) reports progress in clinical trials of a bevacizumab copy biological for age-related macular degeneration and colorectal cancer, while Innovent Biologics reports positive findings from a trial of their bevacizumab copy biological in hepatocellular carcinoma.