Read our latest updates & insights

On 10 October 2024, Samsung Bioepis released its quarterly US Biosimilar Market Report.  The report has been published every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.
The Q4 2024...

New Zealand’s drug-funding body, Pharmac, has announced that Eli Lilly/Merck KgGa’s Erbitux® (cetuximab) will now be funded for left-sided, RAS and BRAF wild-type, metastatic colorectal cancer.  Minor amendments have also been made to eligibility criteria for currentl...

On 10 October 2024, Johnson & Johnson (J&J) announced that it submitted a Type II variation application to the EMA seeking an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone for...

On 10 October 2024, STADA announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

Under an agreement with Alvotech entered in June 2024, STADA has s...

On 9 October 2024, Ono Pharma Taiwan received additional approval of Opdivo® (nivolumab) intravenous infusion in combination with cisplatin and gemcitabine, from the Taiwan Food and Drug Administration, for the first-line treatment of adult patients with unresectable or met...

On 9 October 2024, Biogen announced that its felzartamab received FDA Breakthrough Therapy Designation (BTD) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients.  Felzartamab is an investigational anti-...

On 9 October 2024, Nanjing Leads Biolabs announced that China’s Center for Drug Evaluation of National Medical Products Administration granted Breakthrough Therapy Designation to LBL-024, an anti-PD-L1/4-1BB bispecific antibody, for the treatment of patients with advanced e...

On 9 October 2024, Bio-Thera Solutions and Gedeon Richter announced that they have entered into an exclusive commercialisation and license agreement for BAT2206, biosimilar to Janssen’s Stelara® (ustekinumab).  Pursuant to the agreement, Bio-Thera continues to be responsibl...

On 8 October 2024,  MSD’s Keytruda® (pembrolizumab) and Astellas/Pfizer’s Padcev® (enfortumab vedotin) were approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a first-line combination treatment for unresectable or metastatic urothelial carcinoma (...