Adalimumab, sold under the brand name Humira among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis. It works by blocking a protein (tumor necrosis factor or TNF) found in the body’s immune system that causes joint swelling and damage in arthritis as well as red scaly patches in psoriasis.
DelveInsight’s, “” report provides comprehensive insights about 35+ companies and 45+ marketed and pipeline drugs in Adalimumab Biosimilars landscape. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
IBI303 is a recombinant human monoclonal antibody of TNF-α, which has the same amino acid sequence as branded adalimumab (Humira) and shows high degrees of similarity in respect to: chemical properties, in vitro biological activity (binding affinity and neutralizing activity against TNF-α), potency, and PK/PD. Pharmacologic and toxicologic studies of IBI303 also showed high similarity to Humira. Clinical studies have demonstrated that IBI303 can significantly alleviate the symptoms and physical signs of AS and decrease the disease activity and enthesitis, while improving both somatic motor ability and mobility of spine in patients with AS. It also improved the quality of life in patients with AS and reduced the disease’s impact on their activities of daily life. IBI303 also generated an acceptable safety profile with most of the adverse events graded as mild or moderate. IBI303 may meet Chinese patients’ urgent needs with an affordable price at global quality standards.
CT-P17 is the first high-concentration type of medicine for a biosimilar made of adalimumab. The company has differentiated CT-P17 from existing Humira biosimilars by halving the dosage. By taking the latest trend into account, Celltrion has also removed citrate, which can cause pain in self-injection, from its latest product. If Celltrion launches CT-P17, it will be able to complete a robust portfolio of CT-P17 in the global autoimmune disorder treatment market.
- The companies and academics are working to assess challenges and seek opportunities that could influence Adalimumab R&D. The therapies under development are focused on novel approaches to treat/improve Adalimumab.
- In July 2020, the FDA has approved an adalimumab biosimilar (Hulio) from Fujifilm Kyowa Kirin Biologics, making it the sixth adalimumab biosimilar to AbbVie’s reference product Humira that has been approved and the 28th biosimilar approved by the FDA. Mylan will handle the commercialization in the United States.
- In March 2020, Alvotech announced that it entered into an exclusive license partnership with DKSH, a market expansion services provider, for the commercialization of AVT02, a biosimilar to AbbVie’s HUMIRA (adalimumab), in selected Asia-Pacific (APAC) markets.
- In October 2018, Orion Corporation and Amgen have signed an agreement for the marketing and sales of AMGEVITA, Finland’s first adalimumab biosimilar. Based on its sales value, the original adalimumab product is the most-sold medicine globally and in Finland, and its impact on medicine reimbursement costs is substantial.
Zydus Cadila, Tanvex Biopharma, Synermore Biologics, Shanghai Henlius Biotech, Sandoz, Samsung Bioepis, Prestige BioPharma, PlantPraxis, Pfizer, Outlook Therapeutics, Mylan, and others are involved in Adalimumab biosimilars.
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