Biosimilars/Research
Celltrion’s biosimilars effective against gastric cancer and B-cell lymphoma
Recent clinical trial results confirm that Celltrion’s biosimilars Herzuma (trastuzumab) and Truxima (rituximab) are effective in the treatment of gastric cancer and B-cell lymphoma, respectively.
Monoclonal antibody biosimilars and cancer in the EU
Spanish researchers investigated the current status of biosimilar monoclonal antibodies (mAbs) in the European Union (EU) by reviewing the regulatory pathway, the rationale for extrapolation and switching and the current status and future perspectives of the biosimilars approved in the EU [1].
Biosimilars in oncology in Europe
In the European Union (EU), a legal framework for approving biosimilars was established back in 2003. This framework allows for biosimilars to be approved using an abbreviated pathway centrally via the European Medicines Agency (EMA) [1].
The biosimilars market in Latin America: a summary
A review of the biosimilars market in Latin America [1] finds that Argentina, Brazil and Mexico have the largest number of approved similar biotherapeutic products (SBPs), while information in other countries is more limited. The review recommends investment in biotechnology hubs and further development of regulation on biological drugs.
Adalimumab copy biological shown to be safe and effective
Chinese biopharmaceutical firm Innovent Biologics’ adalimumab copy biological has shown comparable safety and efficacy to the originator drug, Humira (adalimumab), in patients with ankylosing spondylitis.
Sustainable biosimilar policies in Europe
A review of approaches to biosimilar policy in Europe [1] highlights key principles for a sustainable biosimilar market, including supporting innovation and allowing for multiple suppliers.
Biosimilar infliximab reduces medication costs by two thirds in Finland
A study of 54 people with inflammatory bowel disease (IBD) in Finland showed that switching to biosimilar infliximab has no significant impact on health-related quality of life or disease activity, while reducing costs by two thirds [1].
Trastuzumab biosimilar Kanjinti is stable over extended storage periods
An investigation of the quality and in-use stability of diluted trastuzumab biosimilar Kanjinti (also known as ABP 980) versus the reference trastuzumab demonstrated no clinically meaningful differences in stability and activity over extended storage periods, according to Crampton et al. [1].
Quotas improve biosimilar use in Germany
An assessment of the role of cost control measures on biological drugs in Germany finds that quotas for biosimilars are in some cases associated with increased use and are overall more effective than priority prescribing [1].
Denmark achieves 83% reduction in adalimumab costs through switching
Spending on adalimumab in Denmark decreased by almost 83% between September and December 2018, thanks to a mandatory switching policy.
