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Adalimumab Biosimilars Insight

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, “Adalimumab Biosimilar Insight” 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.

Adalimumab Biosimilars Emerging Drugs

  • IBI303: Innovent Biologics

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: Celltrion

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.

 

Further product details are provided in the report. Request @ Adalimumab Biosimilars Drugs

 

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 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.

How many key players are involved in Adalimumab Biosimilars development?

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.

Request sample report @ Adalimumab Biosimilars Key Players

TABLE OF CONTENTS

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

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