Tags : CHMP

AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat

Shots: The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials P-III ETHOS study results reported that triple-combination therapy showed a reduction in the rate of moderate or severe exacerbations compared with the Bevespi […]Read More

Sanofi’s Supemtek Receives CHMP’s Positive Opinion for Approval to Prevent

Shots: The CHMP’s recommendation is based on two P-III studies demonstrating the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000+ patients aged ≥18yrs. The company expects EC’s decision in Q4’20 Supemtek is the first and only influenza vaccine to rely on recombinant manufacturing technology and is available in the US since 2017 […]Read More

Alexion’s Ultomiris (ravulizumab) Receives the CHMP’s Positive Opinion for its

Shots: The CHMP has adopted a positive opinion recommending marketing authorization in the EU for a new 100 mg/mL (IV) advanced formulation of Ultomiris (ravulizumab). The positive opinion is based on CMC submission and a supplementary clinical data set showing that the safety, PK, and immunogenicity following administration of Ultomiris (10mg/mL & 100mg/mL) were comparable […]Read More

Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More

Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for

Shots: The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix Equidacent will be available as 25 mg/ml as the […]Read More