Biocon Biologics announced that it will license its ustekinumab and denosumab biosimilars to Yoshindo for Japan....
Fuji Pharma submits MAA for first biosimilar product
Alvotech announced that Fuji Pharma has submitted a marketing authorisation application to Japan’s Ministry of Health,...
BioFactura’s biosimilar ustekinumab shows comparable PK to Stelara® in Ph I trial
BioFactura has announced successful completion of its Ph I trials relating to biosimilar ustekinumab candidate...
Prestige requests Type 4 meeting with FDA in relation to Tuznue® (biosimilar trastuzumab)
Prestige Biopharma announced that it has submitted a request to the FDA for a pre-submission meeting to discuss the...
Amgen releases 2022 Biosimilars Trends Report
Amgen published its 9th Biosimilars Trends Report, reporting on the current and future state of the US biosimilars...
Jacobio Pharma and Merck enter into clinical trial collaboration for JAB21822 and Erbitux® (cetuximab)
Jacobio Pharma announced it has entered into a clinical trial collaboration agreement with Merck to study Jacobio’s...
FDA accepts aflibercept sBLA for treatment of retinopathy of prematurity for Priority Review
Regeneron announced that the FDA has accepted for Priority Review the sBLA for Eylea® (aflibercept) to treat...
Merck and Moderna collaborating on Personalized Cancer Vaccine under evaluation in combination with KEYTRUDA® (pembrolizumab)
Merck announced that it has exercised its option to jointly develop and commercialise the personalised cancer vaccine...
Janssen publishes data from guselkumab and golimumab trial
Janssen published data from its Ph IIa clinical trials of guselkumab with golimumab in the treatment of ulcerative...
Phase III study for Alvotech’s AVT06 (biosimilar aflibercept) to proceed in India
India’s Central Drug Standard Control Organisation granted permission to IQVIA to conduct Ph III clinical trials of...
Samsung to pursue adalimumab interchangeability in the US
In an interview with Managed Healthcare, Samsung Bioepis’ head of US market access Tom Newcomer announced that Samsung...
Celltrion to commence interchangeability trials of Yuflyma® (biosimilar adalimumab)
Celltrion announced the commencement of Ph III clinical trials regarding Yuflyma® (biosimilar adalimumab) in Estonia. ...
Medicare Part B biosimilar payment commences
A temporary increase in medicare payments for qualifying biosimilars commenced under section 11403 of the Inflation...
Amneal launches Alymsys® (biosimilar bevacizumab) in the US
Amneal Pharmaceuticals announced the launch of Alymsys® (biosimilar bevacizumab) in the US on 03 October 2022. Alymsys...
FDA to pilot new biosimilar program under BsUFA III
The FDA announced that it will pilot a regulatory science program to advance the development of interchangeable...
EMA accepts Biogen tocilizumab MAA
Biogen announced that the EMA has accepted the MAA for BIIB800 (biosimilar tocilizumab). Biogen holds the rights to...