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1.
Efficacy and safety of Sandoz biosimilar rituximab for active rheumatoid arthritis: 52-week results from the randomized controlled ASSIST-RA trial.
Rheumatology (Oxford)
; 60(1): 256-262, 2021 01 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-32699904
2.
GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes.
Br J Clin Pharmacol
; 83(4): 732-741, 2017 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-27790726
3.
Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar.
Bioanalysis
; 16(1): 33-48, 2024 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-38031738
4.
Pharmacokinetics and pharmacodynamics of the proposed biosimilar denosumab GP2411 and reference denosumab in healthy males.
Expert Opin Biol Ther
; 24(1-2): 91-100, 2024.
Artículo
en Inglés
| MEDLINE | ID: mdl-38269652
5.
Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study.
J Bone Miner Res
; 39(3): 202-210, 2024 Apr 19.
Artículo
en Inglés
| MEDLINE | ID: mdl-38477751
6.
Conformational states of human rat sarcoma (Ras) protein complexed with its natural ligand GTP and their role for effector interaction and GTP hydrolysis.
J Biol Chem
; 285(51): 39768-78, 2010 Dec 17.
Artículo
en Inglés
| MEDLINE | ID: mdl-20937837
7.
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bioanalysis
; 13(6): 415-463, 2021 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-33533276
8.
GP2017, an adalimumab biosimilar: pharmacokinetic similarity to its reference medicine and pharmacokinetics comparison of different administration methods.
Expert Opin Biol Ther
; 19(10): 1075-1083, 2019 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-30698045
9.
Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study.
RMD Open
; 4(2): e000757, 2018.
Artículo
en Inglés
| MEDLINE | ID: mdl-30487998
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