Avastin Biosimilars

Overview

Avastin® (bevacizumab) is VEGF-A targeting, humanized monoclonal antibody-based therapeutic developed by Genentech and Roche. It was the first angiogenesis inhibitor drug to be approved by the US FDA. Avastin® was first approved for treatment of advanced colon cancer (2004); since then, the drug has been approved for advanced lung cancers (2006), metastatic breast cancers (2008), kidney cancers and brain (glioblastoma) cancers (2009). Presently, it is considered an important standard of care in oncology. It is worth mentioning that since the establishment of the immune modulatory roles of VEGF, bevacizumab was identified as a viable component of potential combination therapies, particularly with immune checkpoint inhibitors. Therefore, based on the type of cancer that it is being used to treat, Avastin® may or may not be used in combination with conventional chemotherapy drugs. It is worth mentioning that for treating women with metastatic breast cancers, bevacizumab was approved under the FDA’s accelerated approval program – according to which, a therapeutic may receive the green flag for being used to treat a particular disease indication based on the results of past clinical trials. However, in 2010, the FDA issued a statement proposing that Avastin® no longer be used to treat women with metastatic breast cancer, taking into consideration the fact that there was insufficient evidence that the drug is safe and effective for use in this particular indication. In November 2011, the regulator reached a decision and the metastatic breast cancer was withdrawn as an indication for bevacizumab, on account of the drug not being safe and effective for treating the same. Considering the opportunity associated with anticancer therapeutics, the Avastin® biosimilars developer landscape is substantial, and characterized by the presence of multiple big pharma players, such as Abbott Laboratories (Bevacizab™), Amgen (Mvasi®) and Pfizer (Zirabev™). Considering that several enemy products are already in the market, and several others are under development, the bevacizumab biosimilars market is anticipated to witness noteworthy growth in the foreseen future.

Scope of the Report

The “Avastin® (Bevacizumab) 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Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive / Terminated / Withdrawn Biosimilars, Industry / Non-Industry Partnerships” report features an extensive study of the current developer landscape and clinical research scenario related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, Avastin®, 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 bevacizumab 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 bevacizumab 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 bevacizumab 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 bevacizumab 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 Avastin® 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 bevacizumab 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 Avastin®, [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 bevacizumab 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 bevacizumab 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 Avastin® 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

• This deliverable features an executive summary of the contemporary bevacizumab 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. 
• It includes key inputs about the reference product, Avastin®, featuring an overview of the company (AbbVie), information on financial performance and a summary of the annual sales of this blockbuster product. 
• A contemporary pipeline analysis, including summary charts and figures from the Excel deliverable along with key insights drawn from the available data. 
• An analysis of partnerships related to bevacizumab biosimilars, based on a number of parameters, such as year of partnership, type of partnership, and geographical locations of partnering entities. 
• Finally, it includes profiles of companies having approved / launched bevacizumab 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