Mvasi by Amgen is the First FDA Approved Cancer Biosimilar

FDA Approves the First Cancer Biosimilar

Mvasi by Amgen is Hitting the US Market

 

Yesterday the FDA announced that Amgens biosimilar to Avastin, known as Mvasi (bevacizumab-awwb) was approved for five different types of cancer:

  1. Non-squamous non-small cell lung cancer (NSCLC) – in combination with chemotherapy
  2. Metastatic colorectal cancer (mCRC) – in combination with chemotherapy
  3. Glioblastoma
  4. Metastatic renal cell carcinoma in combination with interferon alfa
  5. Persistent, recurrent, or metastatic carcinoma of the cervix – in combination with chemotherapy

According to Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, “The approval of MVASI marks a significant milestone for health care practitioners and patients as the first anti-cancer biosimilar approved in the United States,” Mvasi is a recombinant immunoglobulin G1 (IgG1) monoclonal antibody that functions by binding to vascular endothelial growth factor (VEGF) and subsequently prevents it activating VEGF receptor-1 and VEGF receptor-2. This then prevents downstream signaling and prevents the growth of blood vessels within tumor microenvironments.

To date, clinical trial results have indicated that Mvasi demonstrated similar clinical profiles compared to bevacizumab, and had similar safety, efficacy and immunogenicity profiles. The  European Medicines Agency is also reviewing a Marketing Authorization Application for Mvasi that was submitted in December 2016.

For more information on the biosimilar market, review our BIOSIMILAR MARKET ANALYSIS & FORECAST to 2021. This report provides a comprehensive overview of the size of biosimilars’ market, the segmentation of the market, key players and the vast potential of therapies that are in clinical trials. In total, 45 biosimilars are available in the global market and currently the E.U. is the major market with 19 approved biosimilars in use. A significant number of biosimilars are available in the markets of China, India, South Korea and Latin America. Biosimilars from these emerging countries are approved by a less-stringent approval pathway and therefore, the commercialization of their products is mostly confined to the domestic markets. 
The report includes:

 

  • An overview of biosimilars that includes differences between biologics; biosimilars and generics, definition of biosimilars by different agencies, barriers in developing biosimilars, cost of developing biosimilars.
  • A summary of regulatory pathways in various geographic regions.
  • Development of biosimilars in Europe, China, India, South Korea, Latin America and the sudden spurt in the development of biosimilars in the U.S.
  • A list of biosimilar developers in different geographic locations.
  • An overview of biobetters that includes regulatory considerations, differences between biosimilars and biobetters, various biobetters that are in developmental stages, and the companies with the largest biobetter pipeline.
  • An overview of approved biosimilars in the E.U., U.S., India, South Korea and Latin America.
  • The market impact of biosimilars on their reference biologics such as Epogen, Humira, Remicade, Neupogen, Neulasta, Enbrel, Rituxan, Herceptin, Avastin and Lantus through 2021.
  • The top ten biologics on the focus of biosimilar developers.
  • The five major classes of biologics and their biosimilar counterparts.
  • The current landscape of originators of biosimilars.
  • Global market for biologics by region, through 2021.
  • Global market for biologics by indication, through 2021.
  • Global market for biologics by drug class, through 2021.
  • Global market for biosimilars by region, through 2021.
  • Global market for biosimilars by indication, through 2021.
  • Global market for biosimilars by drug class, through 2021.
  • Profiles of 95 biosimilar developers, their products in the market and their product pipeline.
  • A newsletter in the appendix gives the latest news of biosimilar sector as of February 2015.

 

  Key Questions Answered in This Report

 

  • How do biologics, biosimilars and generics vary from each other?
  • What are the different quality, safety and efficacy assessment tests for biosimilars?
  • How much is being spent for developing a biosimilar molecule?
  • How many years does a biosimilar take to reach the commercial market?
  • How do regulatory pathways differ from region to region?
  • What is the need for biosimilars?
  • What are the different platforms for the development of biosimilars?
  • What is the success rate in the development of a biosimilar when compared to a biologic and generic?
  • What are the most attractive target biologics for the development of biosimilars?
  • How many biosimilars are being developed for Avastin, Enbrel, Herceptin, Humira, Neulasta, and Rituxan, and what are they?
  • How many biosimilar MAbs are being developed and what are they?
  • How much can the U.S. save by the introduction of biosimilars, through 2024?
  • Which companies are involved in developing biosimilar MAbs in South Korea?
  • Who are the Indian players active in Indian biosimilar industry?
  • What are the biosimilar drugs being developed by the Indian biosimilar developers?
  • Name the biosimilars approved in the E.U., India, South Korea and Latin America?
  • What is the current utilization rate of biosimilars in the E.U. countries?
  • The biosimilars approved for use in Germany, Netherlands, U.K., South Korea, Japan, Latin America and India?
  • How far the markets of Epogen, Humira, Remicade, Neupogen, Neulasta, Enbrel, Rituxan, Herceptin, Avastin and Lantus will be affected by the entry of biosimilar counterparts?
  • What are the top ten biologics that have become the focus of biosimilar developers?
  • What are the five major classes of biologics that have attracted the attention of biosimilar developers and what are their current market shares?
  • What are the top ten biologic drugs from 2009 to 2014?
  • Which biologic drugs dominated the U.S. market, between 2010 and 2014?
  • How much is the Medicare Part B spending on biologics in the U.S.?
  • What are the top-eight biologic drugs in the E.U. market?
  • How many biologics maintain absolute dominance in the German market?
  • What is the average cost of a biologic drug in the U.S.?
  • How did the market for biosimilars perform between 2007 and 2014?
  • How small is the market for biosimilars, when compared to that of biologics?
  • What favorable signs are there in the industry to hope for an accelerated growth for biosimilars?
  • What is the projected global and regional market for biosimilars from 2014 to 2021?
  • What is the projected market for biosimilars by major drug classes from 2014 to 2021?
  • Who are the market leaders in the biosimilar sector?
  • What was the market for biosimilars in the major E.U. countries between 2007 and 2013?
  • How much is the competition between biologics and biosimilars in the German market between 2007 and 2020?
  • What is the potential market for biosimilars in the U.S., through 2021?

Fore more information email deirdre@kellysci.com

Deirdre Kelly, Ph.D.
Managing Director
www.kellysci.com
Kelly Scientific Publications
Ireland

http://www.linkedin.com/profile/view?id=34042378

Twitter @kellyscipub 

Kelly Scientific
1-800-618-6812
USA/Canada Toll Free
+353-860-776-750
Rest of World

Tags: , , , ,

Comments are closed.