First European ustekinumab biosimilar to Stelara approved
The first biosimilar to Stelara® is now approved in Europe, a biologic therapy with indications across gastroenterology, dermatology, and rheumatology.
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Crohn’s disease is a type of inflammatory bowel disease that may affect any part of the gastrointestinal tract from mouth to anus. Signs and symptoms often include abdominal pain, diarrhea (which may be bloody if inflammation is severe), fever, and weight loss.
Other complications may occur outside the gastrointestinal tract and include anemia, skin rashes, arthritis, inflammation of the eye, and feeling tired. The skin rashes may be due to infections as well as pyoderma gangrenosum or erythema nodosum. Bowel obstruction also commonly occurs and those with the disease are at greater risk of bowel cancer.
Crohn’s disease is caused by a combination of environmental, immune and bacterial factors in genetically susceptible individuals. It results in a chronic inflammatory disorder, in which the body’s immune system attacks the gastrointestinal tract possibly directed at microbial antigens. While Crohn’s is an immune related disease, it does not appear to be an autoimmune disease (in that the immune system is not being triggered by the body itself). The exact underlying immune problem is not clear; however, it may be an immunodeficiency state. About half of the overall risk is related to genetics with more than 70 genes found to be involved.
The first biosimilar to Stelara® is now approved in Europe, a biologic therapy with indications across gastroenterology, dermatology, and rheumatology.
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).
Roche is set to gain rights to develop, manufacture and commercialise a novel antibody treatment with first-in-class and best-in-disease potential for inflammatory bowel disease (IBD), under a new acquisition agreement.
Under a new agreement with Sanofi, Teva could receive up to $1.5 billion for its novel anti-TL1A therapy, a potential best-in-class option for inflammatory bowel disease (IBD).
A new commercialisation agreement between Sandoz and Samsung Bioepis’ for its ustekinumab biosimilar candidate, means Sandoz now has five potential high-value biosimilars anticipated to launch over the next two years.
Sandoz’s Tyruko (natalizumab-sztn) is now the first US Food and Drug Administration (FDA)-approved biosimilar to Tysabri (natalizumab) injection for relapsing forms of multiple sclerosis.
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
AbbVie’s Rinvoq® will be the first JAK inhibitor available for treatment of Crohn’s in England and Wales, following NICE approval.
Through a $10.8 billion acquisition, Merck has agreed to buy Prometheus Biosciences to advance development of a novel monoclonal antibody for immune conditions.
The MHRA has approved the first marketing authorisation globally for the use of RINVOQ®▼ (upadacitinib) in Crohn's disease.
AMJEVITA™, the first biosimilar to Humira® is now available in the US, based on four years of real-world experience in over 300,000 patients.
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
The US biosimilars market experienced dramatic growth in 2022, particularly for therapies helping to treat oncological and inflammatory conditions, Amgen suggested in a recent report.
Creating new biologic drugs from early research is a complex process, but certain development methodologies and practices are proving to reach clinical and commercial goals faster. In this article, Seahee Kim from Samsung Biologics provides insight into how contract development and manufacturing organisations (CDMOs) are applying new and effective methodologies…