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Sandoz announced that it launched biosimilar natalizumab (Tyruko®) in Germany on 31 January 2024 for the treatment of adults with highly active relapsing remitting multiple sclerosis (RRMS).  Tyruko® was developed by Polpharma Biologics and is the first biosimilar to Biogen...

Biogen announced it will reprioritise resources allocated to Aduhelm® (aducanumab) to advance Leqembi® (lecanemab) to “develop new treatment modalities”.  Biogen will discontinue development and commercialisation of Aduhelm® 100 mg/mL IV injection and will terminate the cur...

Astellas announced it submitted a Supplemental New Drug Application (sNDA) to the Japanese Ministry of Health, Labour and Welfare for Padcev® (enfortumab vedotin (genetical recombination)) with MSD’s Keytruda® (pembrolizumab (genetical recombination)) as a combination thera...

A study by the Italian University of Bologna published in Springer Link’s Clinical Drug Investigation, found that Sandoz’s GP2015 (etanercept biosimilar), Samsung Bioepis’ SB4 (etanercept biosimilar) and Sandoz’s GP2017 (adalimumab biosimilar) have equivalent effectiv...

Johnson & Johnson announced it submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidat...

On 24 January 2024 New Zealand introduced a new IP Bill for Geographical Indications (GIs).
The bill will amend NZ law to implement aspects of the Free Trade Agreement with the European Union signed in Brussels on 9 July 2023 by providing for the registration of Europ...

AstraZeneca and Daiichi Sankyo announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Enhertu® (trastuzumab deruxtecan) and has granted Priority Review to treat patients with unresectable or metastatic HER2-positive (immunohistochemist...

Alvotech announced positive top-line results for AVT03, its biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab).  The study (AVT03-GL-P01) was a randomised, double-blind, parallel-group study evaluating the pharmacokinetics, safety, and tolerability of AVT03 compared t...

Astellas announced that on 26 January the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEVTM (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previ...