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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).

Lupus Foundation of Australia reports a new study demonstrates that rituximab may prove effective as a treatment option for refractory lupus. The study was conducted in 147 people with lupus, and found that six months after the first treatment, 45% of patients demonstrated ...

Targeted Oncology reports the results of a Ph III trial of Samsung Bioepis’ proposed bevacizumab biosimilar, SB8. The researchers reported that the objective response rate ratio of SB8 and bevacizumab appeared equivalent, with comparable safety, pharmacokinetics and i...

Innovent Biologics announces China’s NMPA has approved Sulinno® for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.

A new study examining the analytical and functional similarity of Amgen/Allergan’s proposed rituximab biosimilar ABP798 concludes that it is highly analytically similar to Rituxan®.

NeuClone Pharmaceuticals disclosed it is working on biosimilars referencing Opdivo® (nivolumab) and Keytruda® (pembrolizumab).  The products are in the advanced stages of pre-clinical development and are being developed in partnership with the Serum Institute of India.