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- || BFI-751 (ustekinumab biosimilar) / BioFactura, Aurobindo
P1 data, PK/PD data, Journal: Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1 Trial. (Pubmed Central) - Jul 24, 2023
P1
There were no marked differences in the safety and tolerability profiles for subjects receiving BFI-751 as compared to EU or US ustekinumab. Treatment-emergent adverse events were mild to moderate for all treatment groups.
- ||| BFI-751 (ustekinumab biosimilar) / BioFactura, Aurobindo
Trial completion: Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA (clinicaltrials.gov) - Mar 24, 2022
P1, N=216, Completed, Sponsor: BioFactura Australia Pty Ltd.
Treatment-emergent adverse events were mild to moderate for all treatment groups. Recruiting --> Completed
- ||| BFI-751 (ustekinumab biosimilar) / BioFactura, Aurobindo
Enrollment open: Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA (clinicaltrials.gov) - May 13, 2021
P1, N=228, Recruiting, Sponsor: BioFactura Australia Pty Ltd.
Recruiting --> Completed Not yet recruiting --> Recruiting
- | BFI-751 (ustekinumab biosimilar) / BioFactura, Aurobindo
New P1 trial: Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA (clinicaltrials.gov) - Apr 12, 2021
P1, N=228, Not yet recruiting, Sponsor: BioFactura Australia Pty Ltd.