Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community

por Markus, Richard, Liu, Jennifer, Ramchandani, Monica, Landa, Diana, Born, Teresa, Kaur, Primal
Publicado 2017

A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab

por Kaur, Primal, Chow, Vincent, Zhang, Nan, Moxness, Michael, Kaliyaperumal, Arunan, Markus, Richard
Publicado 2017

SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroi...

por Wechsler, Michael E., Colice, Gene, Griffiths, Janet M., Almqvist, Gun, Skärby, Tor, Piechowiak, Teresa, Kaur, Primal, Bowen, Karin, Hellqvist, Åsa, Mo, May, Garcia Gil, Esther
Publicado 2020

NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents wi...

por Menzies-Gow, Andrew, Colice, Gene, Griffiths, Janet M., Almqvist, Gun, Ponnarambil, Sandhia, Kaur, Primal, Ruberto, Gennaro, Bowen, Karin, Hellqvist, Åsa, Mo, May, Garcia Gil, Esther
Publicado 2020

Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence s...

por Cohen, Stanley, Genovese, Mark C, Choy, Ernest, Perez-Ruiz, Fernando, Matsumoto, Alan, Pavelka, Karel, Pablos, Jose L, Rizzo, Warren, Hrycaj, Pawel, Zhang, Nan, Shergy, William, Kaur, Primal
Publicado 2017