Biosimilars
Clinical trials for adalimumab biosimilar SB5
The clinical trials used to support the approval of Samsung Bioepis/Merck’s adalimumab biosimilar SB5 (Imraldi/Hadlima), were critically reviewed by authors from Argentina and the UK, with a special focus on rheumatoid arthritis (RA) [1].
Merck launches trastuzumab biosimilar in the US
US pharma giant Merck (known as MSD outside the US and Canada) and Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced in on 15 April 2020 that they had launched their trastuzumab biosimilar, Ontruzant, in the US.
Assessment of biosimilarity for monoclonal antibodies
How therapeutic monoclonal antibody biosimilars are assessed for biosimilarity, was discussed by authors from the National Institute of Health Sciences and the Yokohama University of Pharmacy in Japan. Their review covers the basic concept of biosimilar development as well as pharmacokinetic data obtained via non-clinical and clinical studies of biosimilar therapeutic antibodies [1].
FDA releases new information on interchangeable biologicals
The US Food and Drug Administration (FDA) has released new information on its website, clarifying the difference between biosimilars and interchangeable biologicals and says it will make more treatment options available to more people.
EC approval for rituximab biosimilar Ruxience
On 2 April 2020, pharma giant Pfizer announced that its rituximab biosimilar, Ruxience (PF‑05280586), had received European Commission (EC) approval.
Amgevita approved in Colombia
Colombia’s National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos) has approved the first adalimumab producto bioterapéutico similar (similar biotherapeutic product).
Biosimilars highlights: 2019
There were many biosimilars approved in 2019, as well as new clinical trials, research into issues surrounding biosimilar use, and significant regulatory changes [1], as summarized below.
Mabion withdraws application for rituximab biosimilar in EU
Polish biologicals company Mabion Spolka Akcyjna (Mabion) has withdrawn its duplicate applications for its rituximab biosimilar, MabionCD20.
British Columbia releases latest data on biosimilar switches
The latest data on biosimilar switching in British Columbia, Canada shows that 28% of patients with inflammatory bowel disease (IBD) have switched to a biosimilar version of their medication.
Clinical trials for adalimumab biosimilar BI 695501
The clinical trials, especially those in rheumatoid arthritis, used to support the approval of Boehringer Ingelheim’s BI 695501 (Cyltezo), were critically reviewed by authors from Argentina and the UK [1].
