Adalimumab Biosimilars Insight

DelveInsight’s, “Adalimumab– Biosimilar Insight, 2022,” report provides comprehensive insights about 35+ 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.

Geography Covered

  • Global coverage

Adalimumab Understanding

Adalimumab: Overview

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, 2022" 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.

Report Highlights

  • 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 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.

Adalimumab Biosimilars: Drug Chapters

Adalimumab Biosimilars: Marketed Drugs

 

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.

Further product details are provided in the report……..

 

Adalimumab Biosimilars: Emerging Drugs

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

Further product details are provided in the report……..

Adalimumab: Therapeutic Assessment

This segment of the report provides insights about the different Adalimumab biosimilars segregated based on following parameters that define the scope of the report, such as:

  • Major Players in Adalimumab

There are approx. 35+ key companies which are developing the therapies for Adalimumab.

Phases

DelveInsight’s 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

 

Products have been categorized under various Molecule types such as

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

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

Adalimumab: Pipeline Development Activities

The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Adalimumab biosimilars drugs key players involved in developing key drugs.

 

Pipeline Development Activities

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

Adalimumab Biosimilars Report Insights

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

Adalimumab Biosimilar Report Assessment

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

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many 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?

1. Key Insights

2. Adalimumab Biosimilars: Snapshot

3. Executive Summary

3.1. Overview

3.2. The Basics of Biologics.

3.3. Biosimilars are not the Same as Generic Drugs

3.4. Economics of Biosimilars – the Promise of Lower Prices, but at What Cost?

3.5. What Patients Need to Know About Biosimilars

4. Regulatory Outlook For Biosimilars

4.1. North America

4.1.1. US

4.1.2. Canada

4.2. Europe

4.3. Asia Pacific

4.3.1. China

4.3.2. India

4.3.3. Japan

4.3.4. South Korea

4.3.5. Australia

4.4. Rest Of The World

4.4.1. Brazil

4.4.2. Mexico

4.4.3. Argentina

4.4.4. Saudi Arabia

*More Countries would be added in the final report

5. Adalimumab (Reference Product: Humira)

5.1. Drug Profile

5.2. Product Overview

5.3. Regulatory Approvals and Launch

5.4. Indications

5.5. Mechanism of Action

5.6. Dosage and Administration

5.7. Dosage and Strengths

5.8. Dose Modification

5.9. Route of Synthesis

5.10. Pharmacology

5.11. Pharmacodynamics

5.12. Pharmacokinetics

5.13. Adverse Reactions

5.14. Product Snapshot

5.15. Development Milestones

6. Research and Development

6.1. Clinical Trials Information

6.2. Safety and Efficacy

7. Humira Biosimilar:  Emerging Opportunities

8. Adalimumab: Biosimilars Assessment

8.1. Assessment by Product Type

8.2. Assessment by Route of Administration

8.3. Assessment by Molecule type

8.4. Sales Assessment

9. Adalimumab Biosimilars Profiles: By Company

9.1.1. Pfizer

9.1.1.1. Abrilada: Pfizer

9.1.1.1.1. Product Information

9.1.1.1.2. Research and Development

9.1.1.1.3. Other Development Activities

9.1.1.1.4. General Description Table

9.1.2. Innovent Biologics

9.1.2.1. IBI-303: Innovent Biologics

9.1.2.1.1. Product Information

9.1.2.1.2. Research and Development

9.1.2.1.3. Other Development Activities

9.1.2.1.4. General Description Table

9.1.3. Celltrion

9.1.3.1. CT-P17: Celltrion

9.1.3.1.1. Product Information

9.1.3.1.2. Research and Development

9.1.3.1.3. Other Development Activities

9.1.3.1.4. General Description Table

9.1.4. Shanghai Henlius Biotech

9.1.4.1. HLX 03: Shanghai Henlius Biotech

9.1.4.1.1. Product Information

9.1.4.1.2. Research and Development

9.1.4.1.3. Other Development Activities

9.1.4.1.4. General Description Table

9.1.5. Sandoz

9.1.5.1. Hyrimoz: Sandoz

9.1.5.1.1. Product Information

9.1.5.1.2. Research and Development

9.1.5.1.3. Other Development Activities

9.1.5.1.4. General Description Table

9.1.5.2. Halimatoz: Sandoz

9.1.5.2.1. Product Information

9.1.5.2.2. Research and Development

9.1.5.2.3. Other Development Activities

9.1.5.2.4. General Description Table

*More Companies and products would be added in the final report

10. Adalimumab Biosimilars: Comparative Landscape: By Company

11. Adalimumab Biosimilars: Competitive Landscape

11.1.1. Overview

11.1.2. Market Share Analysis

11.1.3. Competitive Scenario

11.1.3.1. Product Launches and approval

11.1.3.2. Partnerships, Collaborations and Agreements

11.1.3.3. Acquisitions

11.1.3.4. Expansions

11.1.3.5. Patent Expiration of Biologics

*More information would be added in the final report

12. Market Drivers

13. Market Barriers

14. SWOT Analysis

15. Appendix 

15.1. Research Methodology

15.1.1. Coverage

15.1.2. Secondary Research

16. Bibliography

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight

List of Table

Table 1: Total Products for Adalimumab

Table 2: Late Stage Products

Table 3: Mid Stage Products

Table 4: Early Stage Products

Table 5: Pre-clinical & Discovery Stage Products

Table 6: Assessment by Product Type

Table 7: Assessment by Stage and Product Type

Table 8: Assessment by Route of Administration

Table 9: Assessment by Stage and Route of Administration

Table 10: Assessment by Molecule Type

Table 11: Assessment by Stage and Molecule Type

Table 12: Inactive Products

List of Figures

Figure 1: Total Products for Adalimumab

Figure 2: Late Stage Products                             

Figure 3: Mid Stage Products

Figure 4: Early Stage Products

Figure 5: Preclinical and Discovery Stage Products

Figure 6: Assessment by Product Type                                                                       

Figure 7: Assessment by Stage and Product Type

Figure 8: Assessment by Route of Administration

Figure 9: Assessment by Stage and Route of Administration

Figure 10: Assessment by Molecule Type

Figure 11: Assessment by Stage and Molecule Type

Figure 12: Inactive Products

• 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

 

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