Biosimilars
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Polish biologicals company Mabion Spolka Akcyjna (Mabion) has withdrawn its duplicate applications for its rituximab biosimilar, MabionCD20.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].
Clinical trials for adalimumab biosimilar ABP 501
The clinical trials used to support the approval of Amgen’s ABP 501 (Amjevita/Amgevita/
Solymbic) were critically reviewed by authors from Argentina and the UK [1].
Non-originator biologicals approved in Bosnia and Herzegovina
Russian biotechnology company Biocad announced on 30 March 2020 that it had received approval for two of its anticancer non-originator biologicals in Bosnia and Herzegovina.
Biocure developing five candidate biosimilars
South Korea’s pharmaceutical industry has fast been expanding as a world player. According to the Korea Health Industry Development Institute, the Korean pharmaceutical industry in 2018 represented 1.8% of the world market, i.e. the 13th largest in the world.
Positive phase III results for Hisun’s adalimumab copy biological
Positive results were reported from a phase III trial of an adalimumab copy biological, HS016, which compared the candidate adalimumab copy biological HS016 with originator adalimumab Humira for the treatment of active ankylosing spondylitis (AS) [1].
Biosimilars and the safe harbor provision
In the US, the safe harbor provision exempts drug development and approval from patent infringement provisions, and courts have interpreted the safe harbor to apply broadly to Food and Drug Administration (FDA) regulated and approved products, including biologicals. However, courts have continued to struggle with the application of the safe harbor to different types of FDA submissions as the regulatory process has become more complex – and largely have continued to expand its scope.
EMA recommends approval of etanercept biosimilar Nepexto
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 March 2020 that it had recommended granting of marketing authorization for a biosimilar etanercept product.
Access to biosimilars in China, the EU and the US
Access to more affordable treatments is the main driver for the approval of biosimilars. But how does this accessibility vary between Europe, the US and China?
