Biotech company Alvotech S.A. (NASDAQ:ALVO) announced on Thursday that the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application for AVT03, a proposed biosimilar candidate to Prolia and Xgeva (denosumab).
The proposed biosimilar has demonstrated clinical similarity to Prolia and Xgeva in terms of efficacy, safety, immunogenicity and pharmacokinetics in postmenopausal women with osteoporosis.
Alvotech develops and manufactures AVT03, and has entered into commercialisation agreements with STADA Arzneimittel AG and Dr. Reddy's Laboratories SA giving each partner semi-exclusive commercial rights in Europe, including Switzerland and the UK.
The European denosumab market is currently valued at approximately USD1bn. Biosimilar competition could expand patient access while potentially reducing overall costs.
EMA accepts marketing application for Alvotech's AVT03
Capricor begins BLA submission for deramiocel in Duchenne muscular dystrophy
GE HealthCare expands AI-enabled enterprise imaging with Blackford integration
Biogen receives FDA Breakthrough Therapy Designation for felzartamab
Inspira Technologies develops new disposable kit for perfusion market
Ananda Developments PLC signs contract for Phase 1 PK study on MRX1
Teva's Prolia biosimilar candidate accepted for review by FDA and EMA
Boehringer receives Breakthrough Therapy designation for survodutide
GBI Biomanufacturing agrees manufacturing collaboration with Allterum Therapeutics