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- ||||||| AVT05 (golimumab biosimilar) / Alvotech, Lupin, Teva
Trial completion: Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX (clinicaltrials.gov) - Oct 1, 2024
P3, N=502, Completed, Sponsor: Alvotech Swiss AG
Active, not recruiting --> Completed
- Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J, AVT05 (golimumab biosimilar) / Alvotech, Lupin, Teva
A PHARMACOKINETIC (PK) SIMILARITY STUDY BETWEEN AVT05 AND REFERENCE PRODUCT GOLIMUMAB () - May 29, 2024 - Abstract #EULAR2024EULAR_3397;
Following a single dose administration, the study supported a demonstration of pharmacokinetic similarity between AVT05 and EU-and US-RP in healthy participants. Safety, tolerability, and immunogenicity profiles were comparable between the treatment arms.
- ||| AVT05 (golimumab biosimilar) / Alvotech, Lupin
Trial completion: A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi (clinicaltrials.gov) - Oct 11, 2023
P1, N=336, Completed, Sponsor: Alvotech Swiss AG
Safety, tolerability, and immunogenicity profiles were comparable between the treatment arms. Active, not recruiting --> Completed
- ||||| AVT05 (golimumab biosimilar) / Alvotech, Lupin, Teva
Enrollment closed: Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX (clinicaltrials.gov) - Sep 21, 2023
P3, N=502, Active, not recruiting, Sponsor: Alvotech Swiss AG
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || AVT05 (golimumab biosimilar) / Alvotech, Lupin
Enrollment closed, Trial completion date, Trial primary completion date: A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi (clinicaltrials.gov) - Aug 14, 2023
P1, N=336, Active, not recruiting, Sponsor: Alvotech Swiss AG
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Oct 2023 | Trial primary completion date: Jun 2023 --> Oct 2023
- ||| AVT05 (golimumab biosimilar) / Alvotech, Lupin
Clinical: $ALVO Alvotech Initiates Confirmatory Patient Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria® #stocks https://t.co/UzXdM0TqKG (Twitter) - May 3, 2023
- |||||||||| AVT05 (golimumab biosimilar) / Alvotech, Lupin, Teva
New P3 trial: Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX (clinicaltrials.gov) - May 3, 2023
P3, N=472, Recruiting, Sponsor: Alvotech Swiss AG
- ||| AVT05 (golimumab biosimilar) / Alvotech, Lupin
Enrollment open: A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi (clinicaltrials.gov) - Jan 17, 2023
P1, N=336, Recruiting, Sponsor: Alvotech Swiss AG
Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Oct 2023 | Trial primary completion date: Jun 2023 --> Oct 2023 Not yet recruiting --> Recruiting
- ||| AVT05 (golimumab biosimilar) / Alvotech, Lupin
PK/PD data: $ALVO Alvotech Initiates Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria® https://t.co/qxDBQ4eKNT (Twitter) - Jan 11, 2023
- ||| AVT05 (golimumab biosimilar) / Alvotech, Lupin
New P1 trial: A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi (clinicaltrials.gov) - Nov 30, 2022
P1, N=336, Not yet recruiting, Sponsor: Alvotech Swiss AG