STADA and Alvotech launch Uzpruvo, the first approved ustekinumab biosimilar to Stelara, across Europe
Positive topline results demonstrate clinical similarity between AVT03 and the reference biologic, Prolia® (denosumab) Two additional studies comparing the pharmacokinetics, safety, and tolerability...
Alvotech and STADA add to strategic alliance through denosumab partnership
INCHEON, Korea, May 27, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today presented follow-up results from Phase 3 study on SB16, a proposed biosimilar to Prolia1 (denosumab) as oral presentation at the 2024 European Calcified Tissue Society (ECTS) Congress being held from May 25th to 28th in Marseille, France. The results up to Month 12 from Phase 3 study were previously presented at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting, and the new data presented today are the results of the switching period, showing SB16 and reference denosumab were comparable up to Month 18.
Dr. Reddy's gets exclusive commercialization rights in the United States (U.S.) as well as semi-exclusive rights in Europe and United Kingdom (UK)Alvotech will be responsible for development and...
European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14
The European Commission (EC) has granted marketing authorisation for Sandoz’s biosimilars Wyost (denosumab) and Jubbonti (denosumab) for bone-related ailments.
Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Wyost® (denosumab) and Jubbonti® (denosumab) approved by EC for all...
HYDERABAD, India and REYKJAVIK, Iceland, May 21, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide (“Alvotech”), and Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as “Dr. Reddy’s”), today announced that the companies have entered into a license and supply agreement for the commercialization of AVT03, Alvotech’s biosimilar candidate to Prolia® and Xgeva® (denosumab). The collaboration combines Dr. Reddy’s global commercial presence with Alvotech’s proven capabilities in developing biosimilars for markets worldwide.
Biopharmaceutical company Mabwell has announced that Denosumab Injection (trade name- MAIWEIJIAN) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing authorisation approval by National Medical Products Administration (NMPA). MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.