
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.

IFK Värnamo's Allsvenskan survival hopes were extinguished on Sunday despite a dramatic stoppage-time equalizer from Marcus Antonsson against IF Brommapojkarna. The 1-1 draw at Finnvedsvallen mathematically confirmed Värnamo's relegation to Superettan with three matches remaining in the season. Victor Lind had given Brommapojkarna a late 1-0 lead with just six minutes remaining, setting the stage for Antonsson's last-gasp intervention that ultimately proved insufficient.
The result leaves Värnamo at the bottom of the table, nine points adrift of Östers IF who occupy the relegation playoff position. With Östers IF set to face fellow strugglers Degerfors IF in the next round, at least one of those clubs will reach 26 points—a tally Värnamo cannot match as their maximum possible points total stands at 25. This mathematical certainty confirms Värnamo's immediate return to the second division after three seasons in the top flight.
Värnamo's relegation marks the end of a promising top-flight journey that began with their Superettan championship in 2021. The Småland club followed their promotion with a tenth-place finish in 2022, then surprised many by finishing fifth last season before securing survival through a playoff victory against Landskrona Bois. This season's struggle has seen the team manage only one win, seven draws, and multiple losses across their campaign.
Brommapojkarna, meanwhile, secured a valuable point that strengthens their position in eleventh place, maintaining a four-point cushion above the relegation playoff spot. The Stockholm-based club made one lineup change from their previous outing, with Junior Martinsson Ngouali replacing Kåre Barslund. Värnamo coach Arne Sandstø also made an adjustment, fielding Simon Thern instead of Carl Johansson as both teams sought crucial points in their respective survival battles.