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.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Switching Patterns Highlight Nocebo Effect in European Patients Using Amgevita
July 23rd 2024About half of the patients in a European study who transitioned from reference adalimumab to a biosimilar version stayed on the biosimilar at the 1-year mark. However, researchers warned about a possible nocebo effect resulting in some patients switching back to the originator.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Eye on Pharma: EU Biosimilar Approval, Launches and Product Returns, Denosumab Switching Data
July 10th 2024The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.