
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval for AVT03, Alvotech's proposed biosimilar to Prolia and Xgeva. This positive opinion marks a significant regulatory milestone for the Icelandic biotech company, bringing the medication one step closer to European market availability. The recommendation covers both the 60 mg/mL pre-filled syringe formulation and the 70 mg/mL vial version of the denosumab biosimilar.
AVT03 functions as a human monoclonal antibody that targets the RANK ligand membrane protein, reducing osteoclast activity to decrease bone resorption. Prolia is indicated for treating osteoporosis in postmenopausal women and men at increased fracture risk, while Xgeva prevents bone complications in adults with advanced cancer that has spread to bone. The biosimilar approach aims to provide comparable therapeutic benefits while potentially increasing affordability and access.
Upon final approval by the European Commission, STADA Arzneimittel AG will market the biosimilar under the brand names Kefdensis for the 60 mg/mL formulation and Zvogra for the 70 mg/mL version. Dr. Reddy's Laboratories SA will offer corresponding products named Acvybra and Xbonzy. Both partners hold semi-exclusive commercial rights across Europe, including Switzerland and the United Kingdom.
Joseph McClellan, Alvotech's Chief Scientific and Technical Officer, stated that this development demonstrates how the company's specialized biosimilars platform enables broader access to affordable biologic medicines. The product remains under EMA regulatory review pending a final decision by the European Commission, which typically follows the CHMP's positive recommendation within several months.

Oslo police have issued a stark warning to parents about the dangers of encrypted messaging applications on children's phones, stating there is "no reason" for minors to use such services. During a digital parenting meeting streamed online Sunday afternoon, authorities highlighted how platforms including Telegram, Signal, WhatsApp, and Zangi are being exploited by criminal networks to recruit young people for serious offenses.
Section leader Astri Johanne Holm of Oslo East's local police station emphasized that adults have been "too naive" about children's online activities. "Be interested in what your child is doing on social platforms," Holm advised parents. "There's no reason for a child or youth to walk around with an encrypted app on their phone." The warning comes amid growing concerns about criminal groups targeting vulnerable minors through digital channels.
Recent police operations have resulted in multiple arrests of underage individuals across Norway, with cases linked to criminal networks including Sweden's Foxtrot network. Authorities report that children as young as eleven are being recruited for criminal activities. Holm noted that while many people use encrypted apps legally to protect privacy, criminals exploit these platforms to avoid scrutiny from both police and parents.
The digital parenting event attracted significant public interest, with between 5,000 and 10,000 people following the broadcast across Facebook, YouTube, Instagram, and Discord platforms. During the session, parents submitted over 200 questions about monitoring children's online activity without violating their privacy. Police recommended maintaining open dialogue and curiosity about children's apps and interests as the best prevention strategy, while also implementing broader measures including collaboration with child protection services and schools.