Herceptin Biosimilars

Overview

The HER2 receptor is a well characterized biomarker that is overexpressed in a number of types of cancer cells, including 25% to 30% of breast cancers. Trastuzumab, a humanized monoclonal antibody, was designed to bind to the extracellular domain of HER2, and thereby, inhibit the proliferation of tumor cells that overexpress this particular antigen. It was discovered and developed by scientists at Genentech (a fully own subsidiary of Roche), in collaboration with the University of California, Los Angeles; the first clinical trial of the drug was initiated in 1992. In 1998, it was approved after being fast tracked by the FDA; it was marketed under the brand name Herceptin®. Over time, studies have demonstrated that intravenously administered trastuzumab is an effective single-agent immunotherapeutic intervention against a variety of cancers. Moreover, in combination with certain other chemotherapies (such as paclitaxel), the drug has been shown to significantly improve the median time to disease progression and survival time in patients suffering from metastatic breast cancer (characterized by the overexpression of the HER2 receptor). It is worth mentioning that trastuzumab is also available in three different forms, namely trastuzumab and hyaluronidase-oysk, pertuzumab, trastuzumab, and hyaluronidase-zzxf, and ado-trastuzumab emtansine (an antibody drug conjugate). Considering the opportunity associated with this product, its corresponding biosimilar developer landscape is also vast. With multiple enemy products already in the market, and several others under development, the trastuzumab biosimilars market is anticipated to witness noteworthy growth in the short-mid term. 

Scope of the Report

The “Herceptin® (Trastuzumab) Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive / Terminated / Withdrawn Biosimilars, Industry / Non-Industry Partnerships” report features an extensive study of the current developer landscape and clinical research scenario related to all the follow-on products of the blockbuster biologic drug, Herceptin®, which are either available or under development. The information in this report has been presented across two deliverables, namely an Excel sheet, featuring an interactive dashboard, and a PowerPoint presentation, summarizing the ongoing activity in this domain, and key insights drawn from the available data. The report features the following details:

• Detailed review of the trastuzumab biosimilars pipeline and affiliated developer landscape, featuring a list of involved innovator companies and their respective therapy candidates. It includes insights based on the current status of biosimilar candidates, and important developer related details (including headquarters, and type of developer).
• An analysis of the various trastuzumab biosimilar candidates that have either been approved and / or launched across developed and developing markets, worldwide. The insights presented in this section are based on a number of relevant parameters, such as current status, year of approval / launch, and geographies where the product has been approved / launched.
• An assessment of the trastuzumab biosimilars that are under development, featuring details such as current phase of development and geographical locations where clinical / preclinical research is underway. In addition to the molecules that are in the pipeline, the report also features information on research grade products and inactive, terminated and withdrawn product development programs.
• An analysis of the various partnerships related to trastuzumab biosimilars, based on parameters, such as year of partnership, type of partnership, and geographical locations of partnering entities. 
• A detailed assessment of the various marketing and distribution agreements inked in relation to Herceptin® biosimilars, highlighting the key players involved.

Deliverable Outlines

Excel Deliverable

1. The deliverable includes an interactive MS Excel dashboard, offering a wholesome perspective of the trastuzumab biosimilars pipeline and the partnership activity in this segment of the biopharmaceutical market. The dashboard is divided into seven independent sections (A-G) that include summary charts and figures (along with relevant slicers) corresponding to [A] the overall follow-on products landscape for Herceptin®, [B] approved and launched therapies, [C] investigational and research products, [D] inactive / terminated / withdrawn biosimilars, [E] companies that have entered into commercialization agreements with biosimilar developers, [F] partnerships inked between companies involved in the development of trastuzumab biosimilars and [G] a drop down menu driven visualization section, where importation details of individual biosimilar can be visualized. 
2. It also features five data tables, featuring [A] a detailed summary of the unique trastuzumab biosimilars that are already approved or under development, [B] information on approved / launched product and the geographies wherein they are authorized to be marketed, [C] details of Herceptin® biosimilars that are in the pipeline, those that are intended for research use only and inactive / terminated / withdrawn programs, [D] identities of companies that have entered into marketing and distribution partnership with product developers in this domain, and [E] details related to the publicly reported partnership activity between stakeholders in this segment of the biosimilars market. 

PowerPoint Deiverable

1. This deliverable features an executive summary of the contemporary trastuzumab biosimilars market, featuring details, such as number of products available / under development, their respective current statuses, information on their developers and commercialization partners and a summary of the partnership activity in this domain. 
2. It includes key inputs about the reference product, Herceptin®, featuring an overview of the company (AbbVie), information on financial performance and a summary of the annual sales of this blockbuster product. 
3. A contemporary pipeline analysis, including summary charts and figures from the Excel deliverable along with key insights drawn from the available data. 
4. An analysis of partnerships related to trastuzumab biosimilars, based on a number of parameters, such as year of partnership, type of partnership, and geographical locations of partnering entities. 
5. Finally, it includes profiles of companies having approved / launched trastuzumab biosimilars. Each profile includes an overview of the company (including details such as year of establishment, headquarters, and number of employees), its recent financial performance (if available), and important inputs (including an over of the product, presentation formats, and indications for which it is approved and dosage information) related to its proprietary biosimilar products.