Trastuzumab Biosimilars Insight 2023

DelveInsight’s, “Trastuzumab Biosimilar Insight, 2024” 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 Biosimilar: 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 Recent Developments

• On May 1, 2024, the FDA approved trastuzumab-strf (Hercessi, Accord BioPharma/Intas Pharmaceuticals) as a biosimilar to trastuzumab for treating certain HER2-overexpressing malignancies. This biosimilar is indicated for the adjuvant treatment of HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
• Earlier, on February 5, 2024, Aprogen Inc., a South Korean biopharmaceutical company, announced that its Phase 3 clinical trial for its trastuzumab biosimilar, AP063, received approval from India's Central Drugs Standard Control Organization (CDSCO). Aprogen also applied to the European Medicines Agency (EMA) in October of the previous year for permission to conduct Phase 3 trials with 720 patients suffering from HER2-positive breast cancer.
• Additionally, on April 5, 2023, Accord BioPharma, the U.S. division of Intas Pharmaceuticals, announced that the FDA had accepted its Biologics License Application (BLA) for HLX02, a proposed trastuzumab biosimilar. This application is for the adjuvant treatment of HER2-overexpressing breast cancer, as well as the treatment of HER2-overexpressing metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

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.

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

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.

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

Trastuzumab Biosimilars 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:

• Trastuzumab Biosimilar Companies

There are approx. 35+ key companies developing Trastuzumab Biosimilar.

• Phases

DelveInsight’s report covers around 35+ Trastuzumab Biosimilar 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

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

Trastuzumab Biosimilars: 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.

Trastuzumab Biosimilars 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.

Trastuzumab Biosimilars 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 Biosimilars 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 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?

Trastuzumab Biosimilar Companies Active in the Market

• 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
• BIOCND
• Biocad
• AryoGen Pharmed
• Apobiologix
• Alteogen
• Shanghai Henlius Biotech and many others.

Trastuzumab Biosimilar Products Analysed in the Report

• 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 and many more.