On June 15, 2021 Alvotech announced that data collection has been completed from the last of its 568 clinical trial study participants in AVT02-GL-302, a switching study for AVT02, the company’s biosimilar to high concentration (100mg/mL) Humira®. The switching study compared the pharmacokinetics, efficacy, safety, and immunogenicity of AVT02 (40…
On May 11, 2021, Alvotech USA and Alvotech hf (jointly, Alvotech) filed a complaint seeking declaratory judgement against AbbVie Inc. and AbbVie Biotechnology Ltd (jointly, AbbVie) in the Eastern District of Virginia. As readers of this blog may recall, in September 2020, Alvotech USA filed a BLA for AVT02, a…
Last week, Alvotech closed out the year with an announcement that it is expanding its high-tech center in Reykjavik, Iceland. This high-tech center, which will almost double the size of the existing facility by the end of 2022, will house “biosimilar development, drug refills, offices and warehouse, in addition to…
Yesterday, Fuji Pharma and Alvotech announced their agreement to extend the companies’ exclusive partnership for the commercialization of four biosimilar medicines in Japan. We previously posted on that partnership when it was first announced in 2018, and later in 2019 when the companies reported that the partnership extended to Alvotech’s…
Alvotech and Cipla Medpro, a wholly owned subsidiary of Cipla Limited, recently announced an exclusive partnership “to bring key biosimilars to patients in markets such as South Africa.” The biosimilars portfolio will include two oncology drugs and three drugs for treating autoimmune diseases. The press release reports that under the…
Yesterday, Alvotech announced that its parent company, Alvotech Holdings SA, completed a $65 million private placement round, which the company said is part of its $100 million private placement round with a second closing expected shortly. Alvotech further reported that the $65 million financing resulted in the company issuing new…
Alvotech and DKSH recently announced an expansion of their strategic partnership to commercialize six new biosimilar candidates for the Asian markets. The press release does not name the biosimilar candidates, but states that they “address[] multiple therapeutic areas.” The companies previously entered into an exclusive license partnership for Alvotech’s adalimumab…
On March 24, 2020, Alvotech HF announced that it entered into an exclusive license partnership with DKSH, a market expansion services provider, for the commercialization of AVT02, a biosimilar to AbbVie’s HUMIRA (adalimumab), in selected Asia-Pacific (APAC) markets. According to the press release, Alvotech will be responsible for the development…
Below are some recent developments in the biosimilar industry from around the globe: On January 14, 2020, Alvotech announced that it entered into a partnership with Canada-based JAMP Pharma for the supply and commercialization of five biosimilar candidates in the Canadian market. According to the announcement, Alvotech will be responsible…
Following the string of biosimilar agreements announced in early November, a number of additional transactions were announced in early December, bringing 2019 to a roaring close with global biosimilars deals. On December 1, 2019, Luye Pharma Group announced that it acquired Shandong Boan Biological Technology Co. Ltd. (Boan), strengthening its…