Biosimilars/Research

Biosimilar education gaps in oncology

Biosimilars/Research | Posted 15/05/2020

A survey administered by the International Society of Oncology Pharmacy Practitioners (ISOPP) identifies key educational needs on biosimilars amongst its practitioners, including how to compare a biosimilar to an originator and how to manage switching [1].

Non-innovator biologicals in India: regulatory context and areas for improvement

Biosimilars/Research | Posted 04/05/2020

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

Clinical trials for adalimumab biosimilar SB5

Biosimilars/Research | Posted 04/05/2020

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].

Clinical trials for adalimumab biosimilar BI 695501

Biosimilars/Research | Posted 17/04/2020

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

Biosimilars/Research | Posted 10/04/2020

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].

Clinical trials supporting the approval of adalimumab biosimilars

Biosimilars/Research | Posted 03/04/2020

Authors from Argentina and the UK critically review the evidence from trials of biosimilars in rheumatoid arthritis (RA) [1].

Assessment of biosimilarity for monoclonal antibodies

Biosimilars/Research | Posted 24/04/2020

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].

Positive phase III results for Hisun’s adalimumab copy biological

Biosimilars/Research | Posted 10/04/2020

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].

Cost savings from the use of biosimilars in Canada

Biosimilars/Research | Posted 27/03/2020

Analysis of the potential cost savings from the use of three biosimilars (filgrastim, infliximab and insulin glargine) in Canada shows that over CA$1 billion could have been saved in just a two-year period [1].