Read our latest updates & insights

Henlius Biotech announced that the TGA has approved Henlius’ trastuzumab biosimilar, which will be marketed in Australia by Cipla.  The 150mg/vial product HANQUYOU has been sold as Zercepac™ in Europe and will be offered under trade names Tuzucip™ and Trastucip™ in Australi...

Sandoz announced that the FDA has accepted its ABLA for a natalizumab biosimilar developed by Polpharma Biologics for all indications covered by the reference medicine Tysabri® including relapsing forms of multiple sclerosis (MS) – clinically isolated syndrome (CIS), relaps...

Sandoz announced that the FDA has accepted its sBLA for a high-concentration citrate-free formulation (100mg/mL) of Hyrimoz® (biosimilar adalimumab).  The 50mg/mL formulation of Hyrimoz® was approved by the FDA in 2018 for the treatment of rheumatoid arthritis, juvenile idi...

Alvotech announced that it has initiated a pharmacokinetic study for AVT03 (denosumab, biosimilar to Prolia®/Xgeva®).  The study will assess the pharmacokinetics, safety and tolerability of AVT03 compared to Prolia® in healthy adult male subjects.

Alvotech’s portfoli...

Novartis published its financial results, reporting a 1% decrease USD (5% increase cc) in Q2 2022 sales over Q2 2021, and 3% decrease USD (5% increase cc) for Sandoz sales.  Novartis confirmed that its strategic review of Sandoz is on track, and that it would provide an upd...

Korea Biomedical Review reported that Celltrion has received approval from Poland’s Pharmaceutical and Medical Equipment Registration Office (URPL) for its IND for Ph III trials of CT-P47 (biosimilar to Actemra®, tocilizumab).

Johnson & Johnson reported a 53% YoY decrease in exports of Remicade® (infliximab) from the US suggesting a very significant decline in global Remicade sales since the first approved biosimilar in 2013.