Shots: Redefining treatment paradigms, monoclonal antibody therapies utilize advanced mechanisms of action to provide care across multiple therapeutic areas As of 2024, the global monoclonal antibody therapy market was valued at $252.6B and is projected to reach $497.5B by 2029, growing at a CAGR of 14.5%. Keytruda leads the market with $29.48B in revenue, followed…
Shots:The EC has approved Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab)Approval covers all indications of the reference products incl. osteoporosis in postmenopausal women & men at high risk of fracture, SRE prevention in adults with bone-involved malignancies, giant cell tumors of bone & treatment-related bone lossAdditionally, Fresenius & Amgen…
Shots:Akeso’s ebdarokimab has received NMPA approval for the treatment of moderate-to-severe plaque psoriasis in adultClinical study showed strong efficacy and safety of ebdarokimab (135mg) two doses at weeks 0 and 4, with a PASI 75 response rate of 79.4% at 16wks. and ebdarokimab Q12W 77.9% at 52wks. along with significant improvements in patients'…
Shots:The EC has approved Leqembi for the treatment of early Alzheimer’s disease in all 30 EEA statesEisai handles global development & regulatory filings for Leqembi, co-commercializing & co-promoting it with Biogen while retaining final decision-making authority. Eisai co-promotes Leqembi with Biogen in the EU (excl. Nordics) & with BioArctic in the Nordic countries, distributing it…
Shots:The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference productsApproval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety,…

