- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Alvotech Hf and DKSH Announce Plans to Bring an Adalimumab Biosimilar to Market
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.
Disease Activity, Safety Remain Following Switch From Infliximab Biosimilar to Remicade in IBD
February 15th 2025Switching back from infliximab biosimilar SB2 to reference infliximab (Remicade) did not affect clinical disease activity or safety in inflammatory bowel disease (IBD), according to a prospective cohort study.
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.
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.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
