Read our latest updates & insights

Fresenius Kabi and Formycon AG announced they reached a settlement in the US with Johnson & Johnson relating to their ustekinumab (FYB202), biosimilar to Stelara®.  As part of the agreement, Fresenius and Formycon can launch in the US “no later than 15 April 2025”.  The...

On 7 August 2023 Gingko Bioworks and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the US and Canada) announced a collaboration to improve biologic manufacturing.  Gingko will “apply its expertise and capabilities in cell engineering, ultra high-throughput mu...

Teva’s CEO confirmed that it will still pursue launching its Alvotech developed adalimumab biosimilar of AbbVie’s Humira® (adalimumab) next year despite seven biosimilars launching in the US on 1 July 2023, and Amgen launching Amjevita® on 31 January 2023.  Teva’s CEO...

Coherus BioSciences announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis®, has quadrupled to $26.7M since the last quarter.  It also reported that its net revenue has risen 81% compared to the previo...

Astellas announced that China’s National Medical Products Administration (NMPA) has accepted its Biologics License Application (BLA) for zolbetuximab as a first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction...

Samsung Bioepis and Organon announced the topline results for their interchangeability study for SB5 (Hadlima®), a biosimilar to AbbVie’s Humira® (adalimumab).  The Phase 4, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical stu...

AstraZeneca announced that the EMA has approved Soliris® (eculizumab) for a new indication: treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive.  Soliris® i...

According to the Korea Biomedical Review Celltrion has applied to the Ministry of Food and Drug Safety for marketing authorisation of its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) for all of Eylea®’s indications approved in Korea, including wet age-relate...