Read our latest updates & insights

On 23 December 2024, following the November 2024 recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult...

On 23 December 2024, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for all indications of Actemra®, including rheumatoid arthritis (RA), systemic juvenile idiopathic arthriti...

On 21 December 2024, Novo Nordisk announced that the US FDA has approved its Alhemo® (concizumab) injection as a once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adult and paediatric patients 12 years or age and older with haemoph...

On 21 December 2024, CuraTeQ Biologics announced that it has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Bevqolva™, biosimilar to Genentech’s Avastin® (bevacizumab).  Bevqolva™ is indicated for various cancer...

On 20 December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its November 2024 meeting.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

Sandoz...

On 20 December 2024, the UPC Court of Appeal denied Alexion preliminary injunctions against Samsung Bioepis and Amgen in relation to the sale of biosimilars to Alexion’s Soliris® (eculizumab) in the EU.  Alexion had originally filed the proceedings in the UPC against Samsun...

On 20 December 2024, Fresenius Kabi announced that it had entered into a licensing agreement with SamChunDang Pharm (SCD) to exclusively commercialise South Korean developed SCD-411, biosimilar to Regeneron’s Eylea® (aflibercept), in the United States, Brazil, Argentina, Ch...

On 19 December 2024, New Zealand’s Pharmac issued a media release requesting feedback on proposals to fund six medicines for cancer and antibiotic resistant infections from 1 April 2025, which includes: 

BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) (in combina...

On 18 December 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the May 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  

The May 2025 agenda lists 8 biologics for consideration, 3 of which are listed for new PBS additio...