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.

Eskilstuna Municipality has filed an appeal against the Swedish Chemicals Agency's decision to grant Senior Material a permit to use methylene chloride in its production of separator film for electric vehicle batteries. The municipal board reached this decision on October 2nd, with the community building committee scheduled to address the matter during its meeting on October 3rd. The appeal represents a significant challenge to the regulatory approval process for industrial chemical use in Sweden.

The controversy centers on methylene chloride, also known as dichloromethane (DCM), a chlorinated solvent that has been nationally prohibited in Sweden since 1996 due to health risks for workers handling the substance. The chemical is classified as carcinogenic and capable of causing genetic changes, while also being harmful to aquatic organisms. Senior Material received an exemption from this ban for its planned production operations, marking a notable exception to Sweden's long-standing restrictions on the substance.

Public concern over the potential environmental impact has manifested in substantial community opposition. Hundreds of demonstrators gathered outside Senior Material's factory in the Svista industrial area on October 1st, expressing worries about future emissions of the chemical. The protest movement has gained momentum through social media campaigns and a petition that has collected over 130,000 signatures demanding the cessation of methylene chloride emissions.

Municipal officials cite multiple grounds for their appeal, particularly emphasizing the volume of methylene chloride approved—1,280 tons over a two-year period—which they describe as unreasonable given Sweden's phase-out objectives for the substance. Niklas Edmark, business director for Eskilstuna Municipality, stated that the approved quantity significantly exceeds what has been permitted in Sweden in recent years and conflicts with national sustainability goals. The municipality argues that the Chemicals Agency should have applied the precautionary principle more rigorously and expanded its assessment criteria given the scale of proposed use.