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Alvotech announced that the FDA has accepted the BLA including data supporting interchangeability for AVT02, Alvotech’s high-concentration (100mg/ml) biosimilar adalimumab.  The Biosimilar User Fee Act goal date for FDA decision is December 2022.

Pfizer announced that the FDA has accepted its sBLA seeking interchangeability for Abrilada™ (biosimilar adalimumab).  The Biosimilar User Fee Act goal date for FDA decision is Q4 2022.

Alvotech and Fuji Pharma announced that they have expanded their strategic partnership for Japan to include an undisclosed biosimilar currently in early phase development.  This brings the total number of products covered by the partnership to six.  Fuji will receive exclus...

Bio-Thera provided an update on its pipeline at the BioPharmaSynergy conference in Amsterdam, reporting that its dupilumab, secukinumab, mepolizumab and vedolizumab biosimilars are in preclinical development.

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.