Biosimilars/Research

Phase III clinical trials started for adalimumab biosimilars

Biosimilars/Research | Posted 05/04/2019

Phase III clinical trials have been started for adalimumab biosimilars from Alvotech and Celltrion.

How can EU policymakers access the potential of biosimilars

Biosimilars/Research | Posted 01/04/2019

Policymakers in Europe should introduce a long-term, multi-stakeholder framework to realize the full potential of off-patent biologicals and biosimilar drugs, according to the results of a series of roundtable discussions held with clinicians, government bodies and industry representatives [1].

Comparison of autoinjectors for inflammatory joint or bowel disease

Biosimilars/Research | Posted 01/04/2019

Imraldi is a biosimilar of the antitumour necrosis factor (TNF) monoclonal antibody adalimumab. It was approved in Europe in August 2017 for the treatment of various inflammatory conditions [1].

Clinician biosimilar prescribing habits and need for education

Biosimilars/Research | Posted 22/03/2019

At present, biosimilar prescribing and clinical use remain contingent on individual healthcare provider preferences. Although novel legislation and policy continue to promote biosimilar drug development, clinician hesitancies curtail biosimilar use in practice, thereby limiting overall market uptake. Findings from a recently published systematic review indicate that clinicians in Europe and the US do not primarily support the use of biosimilars as safe and effective therapies in patients already receiving originator biological treatment [1].

Comparison of Brazilian regulations for follow-on biologicals with EMA, FDA and WHO

Biosimilars/Research | Posted 15/03/2019

Authors Marcos Renato de Assis and Valdair Pinto outline the strengths and weaknesses of the Brazilian regulation on follow-on biologicals and compare regulations in Europe, the US and the world [1].

Trastuzumab biosimilar PF 05280014 non-inferior to Herceptin

Biosimilars/Research | Posted 15/03/2019

Results of a study of Pfizer’s trastuzumab biosimilar (PF 05280014) have shown that the biosimilar is non-inferior to the originator biological, Roche’s Herceptin (trastuzumab) [1].

Positive phase I results for Mycenax’s tocilizumab biosimilar

Biosimilars/Research | Posted 08/03/2019

Taiwanese biosimilars developer Mycenax announced on 31 December 2018 that results from the phase I study of its tocilizumab biosimilar, LusiNEX, had met its primary endpoints.

Mandatory and non-mandatory switching for biosimilars

Biosimilars/Research | Posted 01/03/2019

Glintborg and co-authors responded to the comments made by Marc Scherlinger and Thierry Schaeverbeke on their paper ‘To switch or not to switch’, which reported the results of biosimilar etanercept switching in Denmark [1].

Positive phase III results for rituximab biosimilar CT-P10

Biosimilars/Research | Posted 25/01/2019

Celltrion has presented positive phase III results for its rituximab biosimilar CT‑P10 at the American Society of Hematology Meeting (ASH) annual meeting.

Biosimilar teriparatide approved for the treatment of osteoporosis

Biosimilars/Research | Posted 22/02/2019

Osteoporosis is a modern day epidemic longevity has brought about and represents an enormous socioeconomic burden. Being largely asymptomatic the silent thief can get away with insidiously stealing the patient’s bones until, as a result of the relentless bone loss, fragility fractures inevitably occur. The first, so-called sentinel fracture is the forerunner of the devastating fracture cascade as any prior fracture translates into a two- to four-fold increase in the risk of sustaining a subsequent one within one year [1].