Biocon Biologics launches Yesintek Biosimilar to Stelara in US
YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis
YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis
YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
The biosimilar Ustekinumab has been developed and manufactured by the company
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
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