Alvotech and DKSH Broaden Their Asia Pipeline Agreement

Alvotech and DKSH said they will extend their partnership to include 6 new-but-undisclosed biosimilars for Asian markets. In March of this year, the companies announced intentions to comarket Alvotech’s adalimumab biosimilar candidate (AVT02) in the United States, Europe, and certain Southeast Asian markets for the treatment of several autoimmune disorders: rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, Crohn disease, and ulcerative colitis.

Alvotech is based in Reykjavik, Iceland, and DKSH is in Zurich, Switzerland. In numerous announcements about its licensing plans, Alvotech has not disclosed much about its biosimilars under development. Nevertheless, the company has seen heavy investment in its business model and has a new, state-of-the-art biopharmaceutical facility in Reykjavik.

In January 2019, Alvotech announced the receipt of $300 million from a private bond offering to further its development of biosimilars; at that time, the company had 6 biosimilars in its pipeline, including those for cancer, autoimmune diseases, inflammatory conditions, and other disease states. There have been no announcements of regulatory approval, but the company has anticipated the first of its products would be launched in 2020. 

May of this year saw Alvotech announce positive top-line results for comparative studies for AVT02, which is targeted at the lucrative Humira market and is expected to open to biosimilar competition in 2023. Alvotech reported that a phase 1 pharmacokinetics study comparing AVT02 with the reference product met equivalency margin end points. Similarly, an ongoing phase 3 comparative study for AVT02 demonstrated equivalency for efficacy.

“We have been delighted to work with DKSH since our initial partnership began earlier this year. The partnership is designed to accelerate improved patient access for high-quality biosimilar medicines in the Asian biosimilar industry,” Mark Levick, CEO of Alvotech, said in the most recent statement.

Although DKSH is based in Zurich, the organization specializes in assisting companies in commercializing their products and services in the Asia-Pacific region, where DKSH is active in 36 emerging countries.

Alvotech’s Other Partnerships

Although there have been no regulatory approvals for Alvotech’s biosimilar candidates, the company and its partners are acting as though such approvals are imminent. This is suggested by several colicensing deals signed within the past year.

Alvotech partnered with Teva Pharmaceuticals, Kamada, and JAMP Pharma to commercialize biosimilars in the United States, Israel, and Canada, respectively.

In August 2020, Alvotech signed a deal with Teva is to commercialize 5 biosimilar candidates for the US market. In that case, there also was no disclosure about which reference products they would target.

JAMP Pharma announced in January 2020 that it would license 5 biosimilars from Alvotech for the Canadian market. The companies did not reveal the biosimilar products.

In December 2019, Alvotech partnered with Kamada to commercialize 6 biosimilar candidates for the Israeli market, including PF708, a teriparatide biosimilar. The other 5 biosimilars were not disclosed.