1. Market Research
  2. > Biotechnology
  3. > Biopharmaceutical Market Trends

Commercialisation of Biosimilars: strategies for market penetration

  • November 2013
  • 124 pages
  • Firstword Pharma
Report ID: 1866569


Table of Contents

Times, they are a-changin’—at least for the American biological product market.

With five major biological products worth a collective US$35 billion in annual sales now facing imminent patent expiration, the market is poised to develop and commericialise biosimilars. With the new abbreviated regulatory pathway now in place in the US, the race is on to develop strategies that will ensure the rapid acceptance of biosimilars.

And some of those approaches will come directly from the European experience. While their lessons have been slow in coming, the EU is ahead of the US in market development and currently leads the world in biosimilar sales. Although the European experience differs markedly from the anticipated evolution of biosimilars in the US, there are lessons to be learned.

In Commercialisation of Biosimilars: strategies for market penetration, FirstWord expertly examines the European experience and what it means for other developed markets. Based on expert opinions from the top commentators in the field, the report offers insight into how European biosimilar markets have evolved, includes up to the minute US case studies and which strategies have proven effective—and why.

Key Report Features of Commercialisation of Biosimilars: strategies for market penetration include:

Up to date analysis of the European model and commentary on why uptake varies by market
A look at which products are now in advanced development
Case studies contrasting the US experience of somatropin and enoxaparin
Strategies to improve market penetration

Key Benefits

The biosimilar market in the US is poised to take advantage of major biologicals going off patent. Through Commercialisation of Biosimilars: strategies for market penetration, you will:

Understand the differences in the US experiences with somatropin and enoxaparin biosimilars
Gain insight from experts on potential issues regarding interchangeability, in both regulation and in practice
Gain knowledge of how to design strategies to influence key opinion leaders
Understand why biosimilar acceptance is slower than most new generic drugs

Commercialisation of Biosimilars: strategies for market penetration answers key questions:

How much cross over in practice will be seen between the European and American markets?
What specific strategies will work in kick starting the acceptance of biosimilars in the US?
What are the potential advantages and disadvantages of alternative US biosimilar approval pathways?
How can the industry best educate decision makers on biosimilars’ value, efficacy and safety?
What lessons can be gleaned from US experiences to date?

Key quotes

“When it comes to long term treatments I think that doctors are more reluctant to use biosimilars because immunogenicity concerns have been highlighted by the biotechnology industry. They want to see more evidence on their long term safety.” Steinar Madsen, Medical Director, Norwegian Medicines Agency, Norway

“In a market like the US, you really will need these dual strategies where you need to have a pretty well thought out market access strategy, working with payers, while the sales and marketing tactics, will look a little bit different from what we're used to with traditional innovative products. It's not differentiating on the product profile but it's really establishing biosimilarity.” Sophie Opdyke, VP Commercial Development, Pfizer Biosimilars

“For a biosimilar to come in there and think they're only going to compete on price, I think it's going to be a challenge for them, to say the least. I think we got too used to the analogy of how generics work in the US now and we forget all the early days. It takes a lot of trust building in these early years (of product safety and efficacy), to get people to an understanding to use such products. That's important.” Virginia Acha, Director Regulatory Affairs, Amgen, UK

Content Highlights

As the nascent US biosimilars industry prepares to commercialise, lessons can be learned from the European experience. In this report, you will discover:

The importance of utilising different strategies to enhance market penetration
How development pathway options for drugs targeting multiple diseases will offer the best chance of comprehensive marketing approvals
The anticipated differences in uptake between biosimilar insulin and antibodies indicated for oncology

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 60 Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
  • Single User License — provides access to the report by one individual.
  • Department License — allows you to share the report with up to 5 users
  • Site License — allows the report to be shared amongst all employees in a defined country
  • Corporate License — allows for complete access, globally.

Veronica helps you find the right report:


The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

We were impressed with the support that ReportLinker’s research specialists’ team provided. The report we purchased was useful and provided exactly what we want.

Category Manager at

ReportLinker gave access to reliable and useful data while avoiding dispersing resources and spending too much time on unnecessary research.

Executive Director at
PwC Advisory

The customer service was fast, responsive, and 100% professional in all my dealings (...) If we have more research needs, I'll certainly prioritize working with ReportLinker!

Scott Griffith

Vice President Marketing at
Maurice Sporting Goods

The research specialist provided prompt, helpful instructions for accessing ReportLinker's product. He also followed up to make sure everything went smoothly and to ensure an easy transition to the next stage of my research

Jessica P Huffman

Research Associate at
American Transportation Research Institute

Excellent customer service. Very responsive and fast.

Director, Corporate Strategy at

I reached out to ReportLinker for a detailed market study on the Air Treatment industry. The quality of the report, the research specialist’s willingness to solve my queries exceeded my expectations. I would definitely recommend ReportLinker for in-depth industry information.

Mariana Mendoza

Global Platform Senior Manager at
Whirlpool Corporation

Thanks! I like what you've provided and will certainly come back if I need to do further research works.

Bee Hin Png

CEO at
LDR Pte Ltd

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

Purchase Reports From Reputable Market Research Publishers

Biosimilars Market, Europe, Forecast to 2025

  • $ 4950
  • Industry report
  • March 2017
  • by Frost & Sullivan

A Growing Number of Incentive Policies to Propel Growth in the Next 5–7 Years, with Oncology as the Fastest Adopter Patent expiration and increased use of traditional generic drugs are leading to a ...

Erythropoietin (EPO) Drugs Market Analysis By Drug Class (Biologics, Biosimilars), By Product (Epoetin-alfa, Epoetin-beta, Darbepoetin-alfa, Others), By Application, And Segment Forecasts, 2014 - 2025

  • $ 4950
  • Industry report
  • May 2017
  • by Grand View Research

The global erythropoietin (EPO) drugs market is expected to reach USD 17.4 billion by 2025, according to a new report by Grand View Research, Inc. Rising incidence of chronic diseases such as CKD and cance ...

Global Biosimilars and Follow-On Biologics Market 2017-2027

  • $ 3247
  • Industry report
  • May 2017
  • by Visiongain

Report Details The global biosimilars and follow-on biologics market is expected to grow at a CAGR of 38.8% in the first half of the forecast period and CAGR of 11.3% in the second half of the forecast ...


Reportlinker.com © Copyright 2017. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.