CuraTeQ Biologics receives approval for oncology biosimilar Bevqolva from UK's MHRA
Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins
Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines
Pegfilgrastim is a Pegylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue Filgrastim
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States
The agreement is effective from January 1, 2024 and commercialisation commenced on February 1, 2024
Subscribe To Our Newsletter & Stay Updated