This "Adalimumab - Biosimilar Insight, 2021," report provides comprehensive insights about 34+ companies and 35+ 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.
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.
Adalimumab belongs to a class of drugs known as TNF blockers. By reducing joint swelling, this medication helps to reduce further joint damage and preserve joint function. After treatment with adalimumab, a decrease in levels of acute phase reactant proteins of inflammation (C reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) and serum cytokines (IL-6) was measured compared to baseline in patients diagnosed with rheumatoid arthritis.
Adalimumab Biosimilars: Drugs Chapters
This segment of the Adalimumab report encloses its detailed analysis of various drugs in different stages of clinical development, including marketed, phase III, II, I and preclinical. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Adalimumab Biosimilars: Marketed Drugs
Abrilada is an FDA-approved biosimilar version of adalimumab. Abrilada (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (Abrilada pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. Though approved, it is not yet marketed in the US like several other manufacturers of approved biosimilar versions of adalimumab, Pfizer has signed a licensing agreement with AbbVie; under the agreement, Samsung would be able to launch the drug in November 2023.
Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. Halimatoz contains the active substance adalimumab and is a 'biosimilar medicine'. The active substance in Halimatoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF). TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Halimatoz is used to treat. By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Adalimumab Biosimilars: Emerging Drugs
MYL-1401A is an anti-TNF monoclonal antibody. This tumour necrosis factor inhibitor is a proposed biosimilar of HUMIRA (adalimumab). MYL-1401A is a recombinant human IgG1 monoclonal antibody and is being evaluated as an injectable therapy for the treatment of rheumatoid arthritis and plaque psoriasis.
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. CT-P17 acts as immunosuppressants and tumour necrosis factor alpha inhibitors.
- 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 December 2020, Shanghai Henlius Biotech adalimumab biosimilar candidate HLX03 has been approved by China's National Medical Products Administration for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.
- Innovent Biologics announced that in September 2020, SULINNO (adalimumab biosimilar) has been approved by the National Medical Products Administration (NMPA) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis, polyarticular juvenile idiopathic arthritis in China.
- 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.
- Zydus Cadila
- Tanvex Biopharma
- Synermore Biologics
- Shanghai Henlius Biotech
- Samsung Bioepis
- Prestige BioPharma
- Outlook Therapeutics
- Mylan and Fujifilm Kyowa Kirin Biologics
- Mycenax Biotech
- Momenta Pharmaceuticals
- Meiji Seika Pharma
- LG Chem
- ISU Abxis
- Innovent Biologics
- Hetero Group
- Harvest Moon Pharmaceuticals
- Gene Techno Science
- Fresenius Kabi, Germany [Bought from Merck KGaA (Merck Group)
- Epirus Biopharmaceuticals
- Daiichi Sankyo
- Coherus BioSciences
- Boehringer Ingelheim
- BioXpress Therapeutics
- Bio-Thera Solutions
- Bionovis/The Instituto Vital Brazil
- BIOCND/Genor Biopharma
- HLX 03
- PBP 1502
- M 923
- HS 016
- BOW 050
- BX 2922
- MYL 1401A
- GB 232
- BCD 057
- GBS 005
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