Alvotech Hf and DSH hope to get an adalimumab biosimilar approved in the United States, Europe, and selected Southeast Asia markets.
Two European companies provided an update on their plans for bringing an adalimumab biosimilar to market in the United States, Europe, and selected Southeast Asia markets.
Alvotech Hf, of Reykjavik, Iceland, and DKSH, of Zurich, Switzerland, said they have entered into an exclusive license partnership for the commercialization of AVT02, a biosimilar to AbbVie’s Humira, a leading drug for the treatment of several autoimmune diseases, including rheumatoid arthritis, ankylosing spondlytis, plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Chron disease. Humira had worldwide sales of $18.4 billion in 2017.
DKSH, although based in Zurich, specializes in helping companies market their products and services in the Asia-Pacific region, where the DKSH is active in 36 emerging countries.
“Through the partnership, Alvotech Hf gains access to DKHS’s strong commercial network, which will ultimately benefit patients who will get better access to high-quality biosimilar medicines,” Mark Levick, chief executive officer of Alvotech Hf, said.
The companies said an approval application for AVTO2 will be filed with the European Medicines Agency and the FDA in the second half of 2020.
There are 5 adalimumab biosimilars to Humira that have been approved in the US market, none of which is expected to be commercialized until 2023, owing to deals negotiated as a result of AbbVie’s exclusivity rights.
Several adalimumab biosimilars launched in Europe for the first time in 2018, following Humira patent expirations in 2017. Stronger patent filings in the US have been attributed to the earlier EU launches.
Dozens of companies around the world have adalimumab biosimilars in development, including in India, Japan, Singapore, China, and the Republic of Korea.