Adalimumab Biosimilar Report covers the updated marketed and pipeline drug profiles, including clinical and non-clinical stage products, and highlights the inactive pipeline products. It also includes the therapeutics assessment by product type, stage, route of administration, and molecule type.

 

DelveInsight’s Adalimumab Biosimilar Insight report provides an analysis of several drugs in different clinical development stages, covering marketed, phase III, II, I, and preclinical. It also helps to comprehend clinical trial details, expressive pharmacological action, agreements, and collaborations.

 

Adalimumab Biosimilar Report Highlights

• In July 2020, the FDA authorised an Adalimumab biosimilar (Hulio) from Fujifilm Kyowa Kirin Biologics, making it the sixth adalimumab biosimilar to AbbVie’s reference product Humira, which has been approved and the 28th biosimilar authorised by the FDA.
• Adalimumab Biosimilar Insight, 2021 report provides comprehensive insights about 35+ Key Players and 45+ Marketed and Pipeline Drugs in Adalimumab Biosimilars landscape. 
• In November 2019, Pfizer stated that the FDA had approved Abrilada (adalimumab-afzb) as a biosimilar to Humira (adalimumab), to treat specific patients with Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, adult Crohn’s disease, Ulcerative Colitis and Plaque Psoriasis. Pfizer is working on making Abrilada available to U.S. patients as soon as feasible based on the terms of its agreement with AbbVie. It is slated to launch in 2023.
• In March 2020, Alvotech informed that it entered into an exclusive license association with DKSH, a market expansion services provider, to commercialise AVT02, a biosimilar to AbbVie’s HUMIRA (adalimumab), in selected Asia-Pacific (APAC) markets. 
• In February 2019, AbbVie announced that they had received approval for an additional indication of HUMIRA, a fully human anti-TNF-α monoclonal antibody, for hidradenitis suppurativa treatment. With this approval, HUMIRA has become the first treatment in Japan and is now approved for 11 indications in Japan.
• In March 2017, AbbVie announced that the U.S. FDA approved the inclusion of moderate to severe fingernail psoriasis data in the Humira (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis in the United States. 
• In October 2018, Orion Corporation and Amgen signed a deal 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 worldwide and in Finland, and its impact on medicine reimbursement costs is significant.  

 

Humira (adalimumab) is a recombinant human IgG1 monoclonal antibody indicated for alleviating signs and symptoms and prohibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).

 

Download Free Sample Report, Request @ Adalimumab Biosimilar Pipeline Analysis

 

Adalimumab Biosimilars Marketed Drugs

• Abrilada by Pfizer

Abrilada is an FDA-approved biosimilar version of adalimumab. Abrilada (adalimumab-afzb) injection is administered as a sterile, preservative-free solution for subcutaneous administration. Though sanctioned, it is not yet marketed in the US like various other manufacturers of authorized biosimilar versions of adalimumab, Pfizer has signed a licensing contract with AbbVie; under the deal, Samsung might launch the drug in November 2023.

• Halimatoz by Sandoz

Halimatoz is mostly used in adults when their conditions are severe, moderately severe or exacerbated, or when patients cannot use other treatments. Halimatoz comprises the active substance adalimumab and is a biosimilar medicine. The active substance in Halimatoz, adalimumab, is a monoclonal antibody that has been designed to identify and attach to a substance in the body called tumour necrosis factor (TNF). TNF is involved in causing inflammation and is presented at high levels in patients with the diseases that Halimatoz is used for treatment. By attaching to TNF, adalimumab inhibits its activity, thereby lessening inflammation and other symptoms of the diseases.

 

For further product profiles, access @ Adalimumab Biosimilars Marketed Drugs 

 

Scope of Adalimumab Biosimilars Report:

• Coverage: Global 
• Major Players: 35+ Key Companies  
• Prominent Players: Zydus Cadila, Tanvex Biopharma, Synermore Biologics, Shanghai Henlius Biotech, Sandoz, Samsung Bioepis, Prestige BioPharma, PlantPraxis, Pfizer, Outlook Therapeutics, Mylan, Fujifilm Kyowa Kirin Biologics, Mycenax Biotech, Momenta Pharmaceuticals, Meiji Seika Pharma, LG Chem, ISU Abxis, Innovent Biologics, Hisun Pharmaceuticals, Hetero Group, Harvest Moon Pharmaceuticals, Gene Techno Science, Fresenius Kabi, Epirus Biopharmaceuticals, Daiichi Sankyo, Coherus BioSciences, CinnaGen, Celltrion, Boehringer Ingelheim, BioXpress Therapeutics, Bio-Thera Solutions, Bionovis, The Instituto Vital Brazil, Biogen, Biocon, BIOCND, Genor Biopharma, Biocad, Amgen, Alvotech, mAbxience, and many others.  
• Key Drugs Profiles: 45+ Products  
• Adalimumab Biosimilars Drugs: Adaly, TX17, SYN-060, HLX 03, Halimatoz, Hyrimoz, Hadlima, PBP 1502, Abrilada/Amsparity, Abrilada, ONS-3010, MYL-1401A, Hulio, M 923, DMB-3113, LBAL, ISU202, IBI-303, HS 016, Pamera, Idacio/Kromeya, BOW 050, CHS-1420, Cinnora, CT-P17, Cyltezo, BX 2922, BAT-1406/Qleti, QLETLI, Imraldi, MYL 1401A, GB 232, BCD-057, BCD-058, Amgevita, Amjevita, Solymbic, AVT-02, HLX03, SB5/HADLIMA, AMAB, BCD 057, GBS 005, and many others.   
• Phases:  

• Adalimumab Therapies Late-stage (BLA Filed and Phase III)  
• Adalimumab Therapies (Phase II)
• Adalimumab Therapies (Phase I) 
• Adalimumab Therapies Pre-clinical stage and Discovery candidates  
• Discontinued and Inactive candidates 

• Molecule Types:  

• Small molecule
• Monoclonal antibodies
• Peptide
• Protein

• Route of Administration:

• Subcutaneous

• Product Types:

• Mono
• Combination 
• Mono/Combination 

 

Table of Contents 

1	Key Insights
2	Adalimumab Biosimilars: Snapshot
3	Adalimumab Biosimilars Executive Summary
4	Regulatory Outlook For Biosimilars
4.1.	North America
4.2.	Europe
4.3.	Asia Pacific
4.4.	Rest Of The World
5	Adalimumab (Humira)
6	Research and Development
7	Remicade Biosimilar Emerging Opportunities
8	Adalimumab Biosimilars Assessment
9	Adalimumab Biosimilars Profiles: By Company
9.1.	Abrilada: Pfizer
9.2.	Hulio: Fujifilm Kyowa Kirin Biologics
9.3.	HLX 03: Shanghai Henlius Biotech
9.4.	Pamera: Hetero Biopharma
9.5.	Qletli: Bio-Thera Solutions
10	Adalimumab Biosimilars Comparative Landscape: By Company
11	Adalimumab Biosimilars Competitive Landscape
12	Adalimumab Biosimilars Market Drivers
13	Adalimumab Biosimilars Market Drivers
14	Adalimumab Biosimilars SWOT Analysis
15	Appendix
16	Bibliography
17	DelveInsight Capabilities
18	Disclaimer
19	About DelveInsight

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end to end comprehensive solutions to improve their performance.

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