Shots: The EMA’s CHMP has recommended the approval of Alvotech‘s AVT02 (100 mg/mL), a proposed biosimilar to Humira (adalimumab) to treat AD in the EU The EC has been assigned to discuss […]readmore
Tags : Proposed Biosimilar
Shots: The company initiates P-III clinical trial to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 vs Stelara in a ratio (1:1) in patients with moderate to severe […]readmore
Shots: The first patient has been dosed in a P-III clinical study evaluating the efficacy and safety of BAT2206 vs reference Stelara in ~ 472 patients with moderately to severely […]readmore
Shots: The company reported that all the P-I studies assessing insulin aspart (GL-ASP), insulin lispro (GL-LIS), and insulin glargine (GL-GLA) met their primary PK & PD analyses and demonstrated that […]readmore
Shots: The purpose of the switching study (AVT02-GL-302) is to support the approval of AVT02 in the US as an interchangeable biosimilar product with the high concentration (100mg/mL) dosage forms […]readmore
Shots: The P-lll study will assess the efficacy, safety, pharmacokinetics PK/PD, and immunogenicity of SB16 vs Prolia in 432 female volunteers for postmenopausal osteoporosis The company has initiated the P-I […]readmore
Shots: The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an […]readmore
Shots: The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves […]readmore
Shots: The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206, a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product […]readmore
Shots: The P-III study will compare the efficacy, safety, PK, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration The company has two ophthalmology biosimilar […]readmore