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Trastuzumab-Biosimilars Insight, 2022

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  • 125 Pages
  • January 2022
  • Region: Global
  • DelveInsight
  • ID: 5141802
This “Trastuzumab- Biosimilar 2022” report provides comprehensive insights about 35+ companies and 35+ marketed and pipeline drugs in Trastuzumab 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

Trastuzumab Understanding

Trastuzumab: Overview

Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer. It is specifically used for cancer that is HER2 receptor positive. It may be used by itself or together with other chemotherapy medication. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture which may contain the antibiotic gentamicin. Gentamicin is not detectable in the final product. Herceptin (trastuzumab) for injection is a sterile, white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration.

Trastuzumab Biosimilars: Drugs Chapters

This segment of the Trastuzumab 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.

Trastuzumab Biosimilars: Marketed Drugs

Kanjinti: Amgen

Kanjinti is a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody. The active ingredient of KANJINTI is a humanized monoclonal antibody that has the same amino acid sequence, structure and function as trastuzumab. Kanjinti has the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab.

Herzuma: Celltrion

Herzuma is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer. Herzuma is the second FDA-approved trastuzumab biosimilar, following Mylan and Biocon's approval for Ogivri in December 2017 (Ogivri has not yet launched in the United States). Herzuma has also earned approval in the European Union (where it is marketed by Mundipharma), in Japan (where it is marketed by Daiichi Sankyo), and in Australia.

Trastuzumab Biosimilars: Emerging Drugs

EG12014: EirGenix

EG12014 is a biosimilar of trastuzumab, which is Roche's monoclonal antibody with brand name called Herceptin. A biosimilar drug is a near-identical copy of an original biologics and a different company can manufacture it after the expiration of the original biologics' patent. Eirgenix has begun preparations for a phase III clinical trial which would be conducted in the US and European nations. The outcome paves the way for new opportunities for lower-priced biosimilar drugs as patents on mainstream oncology drugs approach their expiration dates in the next few years.

HD201: Prestige BioPharma

HD201 is a mAb biosimilar to Roche's Herceptin which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Prestige's HD201 is in phase-III clinical development for filing with European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) in 2019.

Trastuzumab: Therapeutic Assessment

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

Major Players in Trastuzumab

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


The 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

Trastuzumab 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
  • Intravenous
  • Parenteral
  • Molecule Type

Products have been categorized under various Molecule types such as

  • Monoclonal antibodies
  • Peptide
  • Protein
  • Small molecule

Product Type

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

Trastuzumab: Pipeline Development Activities

The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Trastuzumab 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 Trastuzumab biosimilar drugs.

Report Highlights

  • The companies and academics are working to assess challenges and seek opportunities that could influence Trastuzumab R&D. The therapies under development are focused on novel approaches to treat/improve Trastuzumab.
  • In June 2019, Amgen and Allergan announced that the U.S. Food and Drug Administration (FDA) has approved Kanjinti (trastuzumab-anns) for all approved indications of the reference product, Herceptin (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Trastuzumab Biosimilars Report Insights
  • Trastuzumab Biosimilar Pipeline Analysis
  • Therapeutic Assessment
  • Sales Assessment
  • Unmet Needs
  • Impact of Drugs

Trastuzumab Biosimilar Report Assessment

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

Key Questions Answered

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Trastuzumab Biosimilars?
  • How many Trastuzumab 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 Trastuzumab biosimilars therapeutics?
  • What are the clinical studies going on for Trastuzumab biosimilars and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • Sunshine Guojian Pharmaceutical
  • STC Biologics
  • Shanghai Institute of Biological Products
  • Samsung Bioepis
  • Protheragen
  • Prestige Biopharma
  • Outlook Therapeutics
  • Nichi-Iko Pharmaceutical
  • Aprogen
  • NeuClone
  • Serum Institute of India
  • Mycenax Biotech
  • Meiji Seika Pharma
  • Mabpharm
  • Mabion
  • Jiangsu Hengrui Medicine Co.
  • ISU Abxis
  • International Biotech Center Generium
  • HisunPharmaceuticals
  • Hetero Group
  • Glenmark Pharmaceuticals
  • Genentech
  • Gedeon Richter
  • EirGenix
  • Dr Reddy's Laboratories
  • DM Bio
  • BioXpress Therapeutics
  • BioSavita
  • Bionovis
  • BioIntegrator
  • Biocad
  • AryoGen Pharmed
  • Apobiologix
  • Alteogen
  • Shanghai Henlius Biotech

Key Products

  • Cipterbin
  • STC 101
  • SIBP 01
  • SB3
  • Pro-S06
  • HD 201
  • ONS-1050
  • NeuCeptin
  • DMB-3111
  • CMAB 809
  • MabionHER2
  • SHR-1309
  • ISU103
  • GNR-027
  • HS-022
  • HBP7
  • HBP8
  • HBP9
  • HBP10
  • GBR-200
  • Anti-erbB-2- monoclonal antibody
  • EG12014
  • Hervycta
  • DA-3111
  • BX-2318
  • Anti-HER2 mAb biosimilar
  • BI-MAB-03
  • GB 221
  • BCD-022
  • AryoTrust
  • ALT02
  • HLX02

Table of Contents

1. Key Insights

2. Trastuzumab 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. Trastuzumab (Reference Product: Herceptin)
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. Herceptin Biosimilar: Emerging Opportunities

8. Trastuzumab: 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. Trastuzumab Biosimilars Profiles: By Company
9.1.1. Amgen Kanjinti: Amgen Product Information Research and Development Other Development Activities General Description Table
9.1.2. EirGenix EG12014: EirGenix Product Information Research and Development Other Development Activities General Description Table
9.1.3. Celltrion Herzuma: Celltrion Product Information Research and Development Other Development Activities General Description Table
9.1.4. Prestige BioPharma HD201: Prestige BioPharma Product Information Research and Development Other Development Activities General Description Table
*More Companies and products would be added in the final report

10. Trastuzumab Biosimilars: Comparative Landscape: By Company

11. Trastuzumab Biosimilars: Competitive Landscape
11.1.1. Overview
11.1.2. Market Share Analysis
11.1.3. Competitive Scenario Product Launches and approval Partnerships, Collaborations and Agreements Acquisitions Expansions 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. Publisher Capabilities

18. Disclaimer

19. About the PublisherList of Tables
Table 1 Total Products for Trastuzumab
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 ProductsList of Figures
Figure 1 Total Products for Trastuzumab
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

Companies Mentioned

A selection of companies mentioned in this report includes:

  • Amgen
  • Celltrion
  • EirGenix
  • Prestige BioPharma