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MSD announced Health Canada has approved Brenzys® (biosimilar etanercept) for four new indications:

adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

pediatric patients ages 4 to 17 ye...

Significant biosimilar activities this week include
08 Sep 20 | The Centre for Biosimilars reports a new study published in Diabetes Spectrum suggests FDA biosimilar naming requirements and switching restrictions cause patients to perceive biosimilars as less similar ...

AstraZeneca announced it has resumed clinical trials in the UK and Brazil following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.

A new study presented at the Congress of Clinical Rheumatology East indicates that ustekinumab is safe and efficacious in young and elderly patients with psoriatic arthritis. Researchers reported that there were no clinically meaningful differences in the effectiveness and ...

Neurology Advisor reported a new study indicates that natalizumab may be more effective than fingolimod or BRACETD in reducing relapses in patients with relapsing-remitting multiple sclerosis.

AstraZeneca announced it has voluntarily paused Ph III trials of AZD1222 to investigate a potentially unexplained illness in one of the trials. AZ said it will expedite the review of the single event to minimise any impact to the trial timeline.

The Centre for Biosimilars reports a new study published in Diabetes Spectrum suggests FDA biosimilar naming requirements and switching restrictions cause patients to perceive biosimilars as less similar to reference products. The authors linked the requirement for a biosim...

CSL announced it will supply the Australian Government with 51 million doses of UQ’s vaccine candidate UQ-CSL V451 if proven successful. The first tranche of doses is expected to be available by mid-2021, with additional doses expected in late 2021 and early 2022. The...

Significant biosimilar activities this week include
31 Aug 20 | US | Mylan and Biocon announced the launch of Semglee® (insulin glargine) in vial and pre-filled pen presentations in the US.   Semglee® is indicated for the treatment of adult and pediatric patients with...

Bio-Thera Solutions commences dosing in Ph I clinical trials of BAT2206 (proposed ustekinumab biosimilar).