Adalimumab-Biosimilars Insight, 2022

January 2022 | 90 pages | ID: AC98299541AFEN
DelveInsight

Abstracts

This report can be delivered to the clients within 72-96 hours

DelveInsight’s, “Adalimumab– Biosimilar 2022,” 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.

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. 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: 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.

• Halimatoz: Sandoz

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.

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

Adalimumab Biosimilars: Emerging Drugs

• IBI303: Innovent Biologics

IBI303 is a recombinant human monoclonal antibody of TNF-?, 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-?), 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……..

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 45+ 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.

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.

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 Biosimilars?
• How many Adalimumab biosimilars are developed by each company?
• How many emerging biosimilars are in mid-stage, and late-stage?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Adalimumab biosimilars therapeutics?
• What are the clinical studies going on for Adalimumab biosimilars and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Zydus Cadila
• Tanvex Biopharma
• Synermore Biologics
• Shanghai Henlius Biotech
• Sandoz
• Samsung Bioepis
• Prestige BioPharma
• PlantPraxis
• Pfizer
• Outlook Therapeutics
• Mylan
• Mylan and Fujifilm Kyowa Kirin Biologics
• Mycenax Biotech
• Momenta Pharmaceuticals
• Meiji Seika Pharma
• LG Chem
• ISU Abxis
• Innovent Biologics
• HisunPharmaceuticals
• Hetero Group
• Harvest Moon Pharmaceuticals
• Gene Techno Science
• Fresenius Kabi, Germany [Bought from Merck KGaA (Merck Group)
• Epirus Biopharmaceuticals
• Daiichi Sankyo
• Coherus BioSciences
• CinnaGen
• Celltrion
• Boehringer Ingelheim
• BioXpress Therapeutics
• Bio-Thera Solutions
• Bionovis/The Instituto Vital Brazil
• Biogen
• Biocon/Mylan
• BIOCND/Genor Biopharma
• Biocad
• Amgen
• Alvotech
• mAbxience

Key Products

• 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

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