BIOSIMILARS UPDATES

19 JAN 2024 | AU | March a Bumper Month for Biopharma at the Pharmaceutical Benefits Assessment Committee (PBAC) in Australia According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January...

09 FEB 2024 | AU | Biocon Biologics Enter a Five-year Exclusive Partnership with Sandoz in Australia for Trastuzumab and Bevacizumab Biosimilars On 9 February 2024, Biocon Biologics (Biocon) announced that it has signed a five-year exclusive...

2 FEB 2024 | EU | US | Regeneron’s linvoseltamab MAA Filing Accepted by EMA; BLA Submitted to FDA for Multiple Myeloma Regeneron announced that its marketing authorisation application (MAA) for linvoseltamab to treat adult patients with...

26 JAN 2024 | SG | AbbVie to Expand Biologics Manufacturing Facility in Singapore with US$223M Investment AbbVie announced it will invest US$233M in its biologics manufacturing facility in Singapore.  The investment will add 24,000L of biologics...

19 JAN 2024 | US | Alvotech Provides Update on FDA Facility Inspection for AVT02 and AVT04 Alvotech announced that its facility in Iceland received a form 483 from the FDA with only one observation.  The inspection started on 10 January 2024 and...

12 JAN 2024 | EU | Celltrion Wins European Bids for Yuflyma® (adalimumab) and Remsima® (infliximab) Korea Biomedical Review reported that Celltrion has won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab) in Friuli-Venezia...

05 JAN 2024 | AU | Celltrion’s Remsima SC®, Biobetter to Remsima®, Biosimilar to Janssen’s Remicade® (infliximab), Sales Jump 48% The Korea Biomedical Review has reported that Celltrion confirmed it has increased Australian sales of Remsima SC®,...

15 DEC 2023 | KR | Approval Alert: LG Chem’s Xelenka® Biosimilar to AbbVie’s Humira® (adalimumab) Approved in Korea Korea Biomed reported that LG Chem’s Xelenka®, biosimilar to AbbVie’s Humira® (adalimumab), has been approved by the Korean...