Alvotech Reports the EMA’s Acceptance of MAA for AVT03 (Biosimilar, Prolia and Xgeva)

Shots: The EMA has accepted the marketing authorization application of AVT03, a biosimilar version of Prolia & Xgeva (denosumab) Submission was based on the AVT03-GL-C01 trial among postmenopausal women (n=532) with osteoporosis as well as AVT03-GL-P01 (n=209) & AVT03-GL-P03 (n=208) studies among healthy adults, depicting similarity in efficacy, safety, immunogenicity & PK b/w the drugs …

ByDipanshu DixitOctober 10, 2024

Bio-Thera Collaborates with Gedeon Richter for BAT2206 (Biosimilar, Stelara)

Shots: Bio-Thera has entered into an exclusive commercialization and licensing agreement with Gedeon Richter for BAT2206, a biosimilar version of Stelara (ustekinumab) Bio-Thera will handle development, manufacturing & supply of BAT2206 while Richter will have exclusive commercialization rights across the EU, UK, Switzerland & selected regions. Bio-Thera has already submitted regulatory filing with the EMA…

ByDipanshu DixitOctober 9, 2024

Insights from Coralie Gressier-Sayag on Avapritinib Efficacy Data Presented at EHA 2023

Shots: Coralie started by giving a brief introduction about Systemic Mastocytosis (SM), a rare disease. She told us that in Europe, approximately 40,000 people live with SM, with 80-90% living with Indolent SM and the rest with Advanced SM She then gave an overview of the P-II PATHFINDER study evaluating avapritinib. The study's 2-year follow-up…

BySenior EditorAugust 30, 2023

Alvotech Reports the EMA’s Acceptance of MAA for AVT03 (Biosimilar, Prolia and Xgeva)

Bio-Thera Collaborates with Gedeon Richter for BAT2206 (Biosimilar, Stelara)

Insights from Coralie Gressier-Sayag on Avapritinib Efficacy Data Presented at EHA 2023

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