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.

Casper Ruud captured the Stockholm Open title with a commanding 6-3, 6-2 victory over Ugo Humbert in a final that lasted just 68 minutes. The Norwegian second seed dominated throughout the match, dropping only two points on his serve in the first set and just one point in the second set. After breaking Humbert early in both sets, Ruud comfortably served out the match to claim his second title of 2025, following his earlier Masters 1000 victory in Madrid.

The victory came amid growing concerns about player welfare on the ATP Tour, highlighted by Holger Rune's season-ending injury during the tournament's semifinals. Rune had started strongly in Stockholm, reaching the semifinal round with victories over Marton Fucsovics and Tomas Martin Etcheverry before suffering a torn Achilles tendon that forced his withdrawal from the match against Humbert. The injury abruptly ended Rune's season, preventing his potential qualification for the season finale.

Ruud addressed the injury concerns in post-match comments, expressing frustration with the demanding tournament schedule. "It's very demanding when you go directly from tournament to tournament," Ruud stated. "Holger was in Shanghai last week, and when something is so demanding, something like this can unfortunately happen. We're all in some kind of risk zone when we step onto the pitch." The Norwegian added that while he couldn't confirm a direct connection between Rune's injury and the schedule, "in a way, all injuries are probably because of the tough schedule."

The concerns about player workload extend beyond Ruud's comments, with world No. 9 Jack Draper recently requesting the ATP Tour to reassess its packed calendar. Players have emphasized the need for a more manageable schedule to ensure long and healthy careers. Ruud acknowledged the physical demands, noting that players are "really pushing our own limits at the moment" and expressing sympathy for Rune's unfortunate situation while wishing him a speedy recovery.