Home / Biosimilars / Research

Research

Biosimilars education still needed for US and EU clinicians

A review of the literature has concluded that healthcare providers are still cautious when it comes to biosimilars and that clinician-directed education is still needed to increase biosimilar knowledge, facilitate prescribing changes and increase use of biosimilars [1].

Pharmacokinetic assessment of biosimilar therapeutic monoclonal antibodies

Comparison of the clinical pharmacokinetic (PK) profile of a biosimilar with that of the reference product is an important step in the development of biosimilars. In a recent review, Ishii-Watabe and Kuwabara outline key considerations for the comparative studies required for biosimilar development, focusing on the clinical PK profiles of biosimilar therapeutic monoclonal antibodies (mAbs) and their reference products [1].

ASCO/ASH update ESA recommendations

The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have updated their recommendations on the management of cancer-associated anaemia with erythropoiesis-stimulating agents (ESAs).

Biosimilar comparability assessment

In a recent review, Ishii-Watabe and Kuwabara summarize the principles of biosimilar development and outline key considerations for studies comparing a biosimilar with its reference product [1].

Comparability of biosimilar Ontruzant maintained over three years

Samsung Bioepis has presented positive long-term results for its trastuzumab biosimilar Ontruzant (SB3) at the 16th International Maternal Cancer Congress St Gallen 2019, which was held in Vienna, Austria.

Clinical development of a bevacizumab biosimilar

Authors, Kambiz Novin and Nafiseh Mortazavi, from medical faculties of Iranian Universities, discuss the methodological considerations for the clinical development of a bevacizumab biosimilar [1].

Economic considerations for biosimilars in the US

Smeeding and colleagues explore cost considerations related to biosimilars in the US, and present a broad perspective on value beyond price reduction in a recent review. 

Biosimilar drug packaging does not meet EU guidelines on readability

Analysis of 35 biosimilar medicines licensed by the European Medicines Agency (EMA) finds packaging to be more complex than recommended. None of the packaging leaflets analysed were found to be ‘easy to understand’, with sections on therapeutic indication and side effects found to be the most complex [1].

Efficacy and safety of bevacizumab biosimilar ABP 215

Authors from the US and Europe report data from a phase III study comparing the clinical efficacy and safety of the bevacizumab biosimilar ABP 215 (Mvasi) with originator bevacizumab Avastin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].

Key considerations for biosimilars in the US

Key considerations regarding biosimilars for payers in the US are discussed in a recent review [1]. The authors explore factors promoting the uptake of biosimilars, interchangeability and naming considerations, and challenges to uptake.