Biopharmaceutical CROs Market, By Roots Analysis

Most of the deals reported in the public domain are licensing and commercialization agreements

Herceptin® sales peaked in 2018, a year before the primary patent covering the drug expired in the US; in order to carve out a share of the associated opportunity, stakeholders in the pharma industry have long been developing follow on products


Roots Analysis has announced the addition of the “Herceptin® Trastuzumab Biosimilars Pipeline Review and Partnerships” report to its list of offerings.


The first trastuzumab biosimilar was approved in Europe in 2017 and within a year, the EMA approved four more (2018). Considering the opportunity associated with this blockbuster product, its corresponding biosimilar developer landscape is also vast.



Key Report Highlights


Herceptin®, the first targeted anti-cancer therapy, is an established itself standard of care for a number of different cancers

However, competition from marketed biosimilars was reported to be responsible for over USD 6 billion in losses from Roche’s international revenues in 2020; experts believe that, so far, this is the biggest decline in originator product sales attributable to competition from enemy products.


There are around 30 companies, across the world, involved in the development of biosimilars of Herceptin®

KANJINTI™, developed by Amgen, was one of the first biosimilars to Herceptin® to be approved by European Commission (2018) and the US FDA (2019). In order to enter the market, most developers of trastuzumab have entered into licensing agreements with the originator, Genentech.


Several biosimilar candidates are presently under development across 50+ trials, in various global regions

Many of such investigational leads are in the late stages of development and for several product candidates, new drug applications (NDAs) / marketing authorization applications (MAAs) have already been submitted to regulators in different nations across the world.


Partnership activity, related to biosimilars of trastuzumab, has grown at a gradual pace since 2011

Most of the deals reported in the public domain are licensing and commercialization agreements; this trend can be attributed to the fact that biosimilar developers generally tend to partner with local business entities in order to launch their proprietary offerings across different geographies.


To request a sample copy / brochure of this report, please visit this


Key Questions Answered

  • Who are the key players engaged in the development of biosimilars of trastuzumab?
  • In which global marketplaces are Herceptin® biosimilars currently available?
  • What is the current scenario within the clinical development landscape of trastuzumab biosimilars?
  • How many biosimilar development programs have and what were the reasons?
  • Who are the key players involved in the commercialization of trastuzumab biosimilars across the world?
  • What kind of partnerships have been inked between stakeholders in this domain?


The research includes detailed profiles of companies having approved / launched biosimilars across different global regions; each profile features an overview of the company, information related to its current portfolio of trastuzumab biosimilars, financial information (if available) and key product related specifications.

  • Amgen
  • AryoGen Pharmed
  • Biocad
  • Biocon
  • Celltrion
  • Intas Pharmaceuticals
  • Pfizer
  • Samsung Bioepis
  • Shanghai Henlius Biotech


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You may also be interested in the following titles:

  1. HUMIRA® (Adalimumab) Biosimilars – Pipeline Review and Partnerships
  2. Avastin® (Bevacizumab) Biosimilars – Pipeline Review and Partnerships


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Ben Johnson

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