Biosimilars/Research
Positive phase I results for Bio-Thera’s bevacizumab copy biological
China-based Bio‑Thera Solutions (Bio‑Thera) has published phase I results for its candidate bevacizumab copy biological, BAT1706 [1].
Biosimilars to replace older biologicals for IBD
Biosimilars will gradually replace older biological drugs for IBD, however, issues – such as the safety of multiple switches – remain, says a recent assessment published in Digestive Diseases and Sciences [1].
Positive results for rituximab copy biological IBI301
US-based pharma giant Eli Lilly, and its partner China-based Innovent Biologics (Innovent), announced on 7 May 2019 positive data from two clinical studies of their rituximab copy biological (IBI301) compared to Rituxan (rituximab).
GaBI Journal is the number one journal publishing on biosimilars
The first ever global bibliometric analysis on biosimilars finds that GaBI Journal is the number one journal publishing on biosimilars. The study also shows that research on biosimilars is increasing, but is currently dominated by countries in the West such as the USA [1].
BiosanaPharma starts phase I trial for omalizumab biosimilar in Australia
Dutch biosimilars developer BiosanaPharma announced on 21 February 2019 that it had received permission from the Australian Bellberry Human Research Ethics Committee (HREC) to start a phase I clinical trial of their first pipeline product, omalizumab.
ASCO/ASH give recommendations for biosimilar ESAs
Recommendations for biosimilar erythropoiesis-stimulating agents (ESAs) in the management of cancer-associated anaemia have been issued by the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH).
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].
