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.

Norwegian authorities are investigating an incident where a man suspected of attempted murder was injured during his arrest on the E18 highway in Sandefjord. The Special Unit for Police Matters has launched a mandatory investigation after the suspect sustained a fracture injury while being apprehended by police officers. Evidence from the scene has been secured as part of the probe into the circumstances surrounding the arrest.

The investigation stems from events that began Saturday evening when a woman was shot at a private address in the Unneberg area north of Sandefjord city center. The suspect fled the scene on an electric scooter following the shooting incident, which occurred around 3 PM. Police established a roadblock on the E18 highway as part of their response to the shooting.

The suspect was apprehended at approximately 7:45 PM at the police roadblock, during which he sustained injuries described as a fracture. While the extent of his injuries remains unclear, the Special Unit has initiated its investigation to clarify the sequence of events and circumstances leading to the injury. Both the suspect and the involved police officers will be interviewed in the coming days as part of the mandatory review process.

The man, who has provided an initial statement to police, has been formally charged with attempted murder and was remanded in custody by the Vestfold District Court on Monday morning. Police indicate the suspect and victim were acquainted but did not have a close relationship. The woman who was shot did not sustain life-threatening injuries, though her exact condition remains unknown as authorities continue their parallel investigations into both the shooting incident and the arrest-related injury.