Shots: The P-III AVANA trial compares the efficacy and safety of FKB238 (IV, 15 mg/kg) vs Avastin in a ratio (1:1) in patients with advanced/recurrent non-sq.NSCLC Results: ORR (51.6% vs […]readmore
Tags : Biosimilar
Biosimilars
Celltrion’s Herzuma (biosimilar, trastuzumab) Overtook the Original Treatments for Cancer
Shots: Herzuma wins <51% of the market share in Japan in Jun’21 & secured the top position with the reliability proved by the expanding prescriptions globally. Celltrion is co-promoting Herzuma […]readmore
Shots: Formycon and partner Bioeq have submitted a BLA for FYB201 (biosimilar referencing Lucentis) to the FDA Lucentis is a mAb fragment used to treat various types of macular-degenerative diseases […]readmore
Biosimilars
Celltrion to Supply Herzuma (biosimilar, trastuzumab) and Truxima (biosimilar, rituximab)
Shots: The company has signed a supply agreement for 2 anticancer biosimilars, Herzuma (trastuzumab) and Truxima (rituximab) in Brazil. The supply of Herzuma accounts for ~80% of Brazil’s trastuzumab market […]readmore
Shots: The US FDA has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathways to treat diabetes Semglee will allow pharmacy level substitution […]readmore
Shots: The first patient has been dosed in a P-I study of HLX04-O conducting in patients with wAMD. The primary objective of the study is to evaluate the safety & […]readmore
Shots: Polpharma reported that its JV with Santo Holding, Bioeq has concluded a commercial partnership with Teva for their biosimilar candidate of the ophthalmological drug Ranibizumab (Lucentis) in the EU, […]readmore
Shots: The first patient has been dosed in the comparative, confirmatory efficacy, and safety AVT04-GL-301 clinical study to evaluate AVT04 vs Stelara in ~ 530 patients with plaque psoriasis across […]readmore
Shots: The companies collaborated to commercialize Bioeq’s FYB201 (biosimilar referencing Lucentis) in the EU, Canada, Israel & New Zealand Bioeq will be responsible for the development, registration, and supply of […]readmore
Biosimilars
Regulatory
Innovent’s Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) Receive the NMPA’s
Shots: The approval is based on P-III ORIENT-32 study involves assessing efficacy and safety of Tyvyt + bevacizumab vs sorafenib in 571 patients in a ratio (2:1) as a 1L […]readmore