Alvotech Gains Ground in Japan as Partner Fuji Pharma Secures Approval for Stelara Biosimilar
Alvotech Gains Ground in Japan as Partner Fuji Pharma Secures Approval for Stelara Biosimilar
Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. ("Fuji"), has received marketing approval for AVT04 (ustekinumab), a biosimilar to Stelara, from the Japanese Ministry of Health, Labor and Welfare. Based on publicly available information, AVT04 is the first biosimilar to Stelara to be approved for sale in global markets. Global sales of Stelara reached over $10 billion for the twelve months preceding June 30, 2023, according to the manufacturer's public filings, making it one of the world's highest grossing biologics.
專門爲全球患者開發和製造生物仿製藥的全球生物技術公司Alvotech（納斯達克股票代碼：ALVO）今天宣佈，其在日本的商業化合作夥伴富士製藥有限公司（“富士”）已獲得日本厚生勞動省對Stelara的生物仿製藥 AVT04（ustekinumab）的上市許可。根據公開信息，AVT04 是 Stelara 首款獲准在全球市場銷售的生物仿製藥。根據該製造商的公開文件，在2023年6月30日之前的十二個月中，Stelara的全球銷售額超過100億美元，使其成爲世界上收入最高的生物製劑之一。
譯文內容由第三人軟體翻譯。