Adalimumab Biosimilars Insight

• Adalimumab biosimilars market is expected to rise, estimated by DelveInsight.
• Adalimumab biosimilars companies working in the adalimumab biosimilars market are BioXpress Therapeutics, ISU Abxis, Zydus Cadila, Tanvex Biopharma, PlantPraxis, Gene Techno Science, Genor Biopharma, Meiji Seika Pharma, Synermore Biologics, Prestige BioPharma, Oncobiologics, LG Chem, Mylan, Celltrion, Zhejiang Hisun Pharmaceuticals, Alvotech, Biocad, Boehringer Ingelheim, Biogen, Emcure Pharmaceuticals, Hetero, Fresenius Kabi, Innovent Biologics, Sandoz, Amgen, Bio-Thera Solutions, Pfizer, and others.

DelveInsight’s, “Adalimumab Biosimilar Insight 2024” report provides comprehensive insights about 35+ companies and 35+ marketed and pipeline drugs in Adalimumab Biosimilars market landscape. It covers the marketed and pipeline Adalimumab Biosimilar drugs profiles, including clinical and nonclinical stage products. It also covers the Adalimumab Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline Adalimumab Biosimilar products in Adalimumab Biosimilar market.

Geography Covered

• Global coverage

Adalimumab Biosimilar Market

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. HUMIRA is administered by subcutaneous injection. 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 Pipeline Insight, 2024" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Adalimumab pipeline landscape is provided which includes the disease overview and Adalimumab treatment guidelines. The assessment part of the report embraces, in depth Adalimumab commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Adalimumab collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Recent Developments in the Adalimumab Biosimilars Market

• In May 2024, Celltrion USA announced the availability of adalimumab-aaty, a high-concentration, citrate-free biosimilar to HUMIRA®, at an 85% lower WAC than HUMIRA. The same biosimilar, marketed as YUFLYMA® since July 2023, is available at a 5% discount to HUMIRA's WAC.
• In May 2024, Boehringer Ingelheim announced that the FDA approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) for treating multiple chronic inflammatory diseases.

Adalimumab Biosimilars Market Report Highlights

• The Adalimumab Companies and academics are working to assess challenges and seek opportunities that could influence Adalimumab R&D. The Adalimumab Therapies under development are focused on novel approaches to treat/improve Adalimumab.
• In February 2021, Celltrion Healthcare has gained EU marketing authorization for the first high-concentration, citrate-free adalimumab biosimilar. The company has chosen the brand name Yuflyma for the product, which was referred to as CT-P17 during drug development.
• 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.

Marketed Adalimumab Biosimilars Drugs

• Amjevita: Amgen

AMJEVITA is a biosimilar to Humira (adalimumab), an anti-TNF-α monoclonal antibody. The active ingredient of AMJEVITA is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as Humira. AMJEVITA is approved to treat seven inflammatory diseases including moderate-to-severe rheumatoid arthritis in adults, moderate-to-severe polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, psoriatic arthritis in adults, ankylosing spondylitis in adults, moderate-to-severe chronic plaque psoriasis in adults, moderate-to-severe Crohn's disease in adults and pediatric patients 6 years of age and older and moderate-to-severe ulcerative colitis in adults. AMJEVITA outside the US is marketed as AMGEVITA (adalimumab) and has been prescribed to more than 300,000 patients in over 60 countries.

• Abrilada: Pfizer

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. In December 2019, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of Amsparity as a biosimilar to Humira (adalimumab) for the treatment of certain patients with RA, juvenile idiopathic arthritis, axial spondyloarthritis, PsA, psoriasis, hidradenitis suppurativa, Crohn's disease, UC, uveitis, and pediatric plaque psoriasis.

• Qletli: Bio-Thera Solutions

Qletli is an anti-TNF- α monoclonal antibody. QLETLI binds specifically to soluble and membrane bound TNF-α and blocks its interaction with the p55 and p75 cell surface TNF receptors, effectively neutralizing TNF-α bioactivity.  Bio-Thera Solutions has received approval from the country’s National Medical Products Administration (NMPA) for Qletli, a biosimilar to AbbVie’s Humira (adalimumab). It is the first Humira biosimilar approved in China. The drug secured approval for all eligible indications of Humira, including rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

Emerging Adalimumab Biosimilars Drugs

This segment of the Adalimumab Biosimilars Market Report encloses its detailed analysis of various Adalimumab drugs in different stages of clinical development. It also helps to understand Adalimumab clinical trials details, expressive pharmacological action, agreements and collaborations, and the latest Adalimumab news and press releases.

• AVT02: Innovent Biologics

AVT02 is a monoclonal antibody (mAb) and a proposed biosimilar to Humira (adalimumab). It is being developed for the treatment plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, crohn’s disease, ulcerative colitis. AVT02 acts as immunosuppressants and tumour necrosis factor alpha inhibitors. In November 2020, Alvotech announced that its has filed a Biologics License Application (BLA) for AVT02 to the U.S. Food and Drug Administration (FDA), which has been accepted for review. The FDA is expected to decide on the filing in September 2021. Additionally, the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.

• MYL-1401A: Mylan

MYL-1401A is an anti-TNF monoclonal antibody. This tumor 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. Mylan has completed Phase III multicenter, double-blind, randomized, 2-arm, parallel-group, equivalence study, evaluating efficacy and safety similarity of MYL-1401A compared with Humira in subjects with moderate-to-severe chronic plaque psoriasis.

Adalimumab Biosimilars Market: Therapeutics Assessment

This segment of the Adalimumab Mechanism of Action (MOA) Report provides insights about the different Adalimumab biosimilars segregated based on following parameters that define the scope of the report, such as:

Adalimumab Companies

There are approx. 35+ key Adalimumab Companies which are developing the Adalimumab Therapies.

Phases

DelveInsight’s Adalimumab Biosimilars Market Report covers around 35+ products under different phases of clinical development like

• Marketed stage products
• Late stage products (BLA Filed and Phase III)
• Mid-stage products (Phase II and
• Early-stage products (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Adalimumab pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Subcutaneous
• Molecule Type

Adalimumab Products have been categorized under various Molecule types such as

• Monoclonal antibodies
• Peptide
• Protein
• Small molecule
• Product Type

Adalimumab Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Adalimumab Pipeline Development Activities

The Adalimumab MOA Report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Adalimumab Biosimilars Drugs Companies involved in developing key drugs.

Pipeline Development Activities

The Adalimumab MOA report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Adalimumab biosimilar drugs.

Adalimumab Biosimilars Market Report Insights

• Adalimumab Biosimilar Pipeline Analysis
• Therapeutic Assessment
• Sales Assessment
• Unmet Needs
• Impact of Adalimumab Drugs

Adalimumab Biosimilar Market Report Assessment

• Marketed Adalimumab Biosimilar Product profiles
• Adalimumab Pipeline Product Profiles
• Adalimumab Therapeutic Assessment
• Adalimumab Pipeline Assessment
• Sales Assessment
• Inactive drugs assessment
• Adalimumab Unmet Needs

Key questions answered:

Current Treatment Scenario and Emerging Therapies:

• How many Adalimumab companies are developing Adalimumab drugs?
• How many Adalimumab drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Adalimumab?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Adalimumab therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Adalimumab and their status?
• What are the key designations that have been granted to the emerging drugs?

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