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Prestige BioPharma announced that the manufacturing facility for Tuznue® (biosimilar trastuzumab) has received EUGMP certification.  Tuznue® is under Marketing Authorisation Application review in the EU, Canada and South Korea.

Janssen released data from a Ph 2a clinical trial of guselkumab and golimumab in ulcerative colitis.  Janssen reported that the combination induced higher rates of clinical response, clinical remission, endoscopic improvement and a composite histologic-endoscopic endpoint a...

Australia’s TGA provided a safety update for BMS’ Yervoy® (ipilimumab), resulting in a warning on the PI that ipilimumab has been linked to serous retinal detachment, a rare but serious adverse event.

Celltrion released two data sets on the subcutaneous (SC) form of Remsima® (biosimilar infliximab).  Celltrion reported that switching from IV to SC infliximab leads to higher infliximab trough levels and a lower risk of relapse in patients with IBD.

Coherus BioSciences published its Q4 2021 financial results, reporting a net loss of $45.7 million.  Coherus attributed this net loss to a decrease in the number of units of Udenyca® (biosimilar pegfilgrastim) sold, as well as a decline in net realised price due to increase...

The Korea Times reported that Celltrion’s net profit has grown 20% year-over-year.  Celltrion has reported significant market shares in the US for its infliximab and rituximab biosimilars.

New Zealand’s Pharmac requested feedback on a proposal to provide access to Riximyo® (biosimilar rituximab) for patients with pemphigus.  Riximyo® is not approved for pemphigus in New Zealand and would need to be prescribed by an authorised prescriber in accordance with sec...