Biosimilars: Market Entry Strategies

Report Summary

With sales for the top 50 pharma companies forecast to decline by 1.6% during 2010–16, many leading drugmakers are looking to expand into markets which offer long-term growth, limited competition, and are relatively low risk. One such area is biosimilars, which has attracted both innovative biologics players and generics players alike.

Features and benefits

• Insight into why pharma are tapping into the biosimilars market
• Analysis of biosimilar deal trends among the top 50 pharma companies
• Insight into the top 50 pharma companies active in biosimilars
• Review of the top 50 pharma companies that plan to enter the biosimilars market in the near future
• Summary of the top 50 pharma companies plan to avoid biosimilars

Highlights

Of the companies analyzed, each of the eight generics companies ranked among the top 50 pharma companies have an active interest in biosimilars, reflecting the fact that such products have the opportunity increase the profit margin of generics companies.

Many innovative pharma companies have also entered the biosimilars arena with further companies such as Boehringer Ingelheim showing signs of interest.

However, a number of companies such as AstraZeneca, Bayer, and Roche have stated that they have no plans to enter the biosimilars market, instead maintaining their innovative focus.

Your key questions answered

• Understand how and why different corporate pharma companies are targeting biosimilars
• Examine why some companies have opted not to enter this sector
   

Table of Contents

EXECUTIVE SUMMARY
Introduction
Strategic scoping and focus
Key findings
Related reports

BIOSIMILARS OFFER A RELATIVELY LOW RISK GROWTH STRATEGY FOR PHARMA
Advantages for entering the biosimilar arena
Capture a share of the fast growing biosimilars market
Lower development costs and reduced risk of pipeline failures
Leverages the branded sales model
Biosimilars provide a more stable revenue stream
Biosimilars have the potential to increase profit margins for generics producers
External drivers of the biosimilars market
Growing use of biologic products
A number of blockbuster branded biologics will have expired by the end of 2016
The high cost of biologics will drive payers to look to biosimilars for cost-savings
Biosimilars have seen growing payer and patient acceptance
There are a growing number of navigable biosimilar approval pathways

BIOSIMILAR DEAL TRENDS
Interest in biosimilars varies among the top 50 pharma companies
Actively interested in biosimilars
Plan to enter the biosimilars arena
Will avoid biosimilars
Strategies used by the top 50 pharma companies to enter the biosimilars arena
In-house development, partnership and acquisition deals
Partnership and acquisition deals
Development and commercialization deals
Commercialization deals

LEADING PHARMA COMPANIES ACTIVE IN BIOSIMILARS
Merck & Co. (Merck BioVentures): four key deals have shaped its biosimilars capabilities
Biosimilar portfolio
Biosimilar deals and partnerships
Pfizer: deal with Biocon provides access to biosimilar insulins
Biosimilar portfolio
Biosimilar deals and partnerships
GlaxoSmithKline: opting for a cautious entry in biosimilars
Biosimilar portfolio
Biosimilar deals and partnerships
Biogen Idec: perceives the biosimilars market to be a low risk strategy to generate additional revenue
Biosimilar deals and partnerships
Amgen: deal with Watson marks Amgen’s entrance into the biosimilars arena
Biosimilar deals and partnerships
Daiichi Sankyo (Ranbaxy): gains access to biosimilars via Ranbaxy
Biosimilar portfolio
Biosimilar deals and partnerships
Sandoz: biosimilar success shaped largely through its acquisition of Hexal
Biosimilar portfolio
Biosimilar deals and partnerships
Teva: acquisition of ratiopharm significantly bolstered biosimilar portfolio and capabilities
Biosimilar portfolio
Biosimilar deals and partnerships
Hospira: partnerships have enabled the company to build a considerable biosimilars portfolio
Biosimilar portfolio
Biosimilar deals and partnerships
Stada: turns to collaborations to share the costs and risks of developing biosimilars
Biosimilar portfolio
Biosimilar deals and partnerships
Apotex: collaboration with Intas provides access to biosimilar filgrastim candidates
Biosimilar portfolio
Biosimilar deals and partnerships
Watson: building upon its expertise in women’s health by licensing in biosimilar infertility candidate
Biosimilar portfolio
Biosimilar deals and partnerships
Actavis: joint venture with Bioton provides access to biosimilar insulins
Biosimilar portfolio
Biosimilar deals and partnerships
Mylan: joins forces with Biocon to develop biosimilars
Biosimilar deals and partnerships

LEADING PHARMA COMPANIES LOOKING TO ENTER THE BIOSIMILARS MARKET
Boehringer Ingelheim: plans to capitalize on biopharmaceuticals contract manufacturing

LEADING PHARMA COMPANIES THAT DO NOT PLAN TO ENTER BIOSIMILARS
AstraZeneca: opts for biosuperiors rather than biosimilars
Bayer: sees no attraction in entering the biosimilars sector
Roche: determined to protect its leading biologics offering from biosimilar competition

BIBLIOGRAPHY
Publications and online articles
Datamonitor reports and products

APPENDIX
Exchange rates used in this report

List of Tables

Table: Comparison of operating margins for branded biologics, branded prescription pharma, and generics companies, 2010
Table: Estimated savings anticipated to be gained through the use of biosimilar drugs
Table: Biosimilar and copy-biologic approval pathways
Table: Interest in biosimilars among branded companies ranked among the to 50 pharma companies
Table: Merck & Co. biosimilars portfolio, 2011
Table: Merck & Co. – deals targeting biosimilars
Table: Pfizer biosimilar/copy-biologic portfolio, 2011
Table: Pfizer deals targeting biosimilars
Table: GlaxoSmithKline biosimilars/copy-biologic portfolio, 2011
Table: GlaxoSmithKline deals targeting biosimilars
Table: Biogen Idec deals targeting biosimilars
Table: Amgen – deals targeting biosimilars
Table: Ranbaxy biosimilars/copy-biologic portfolio, 2011
Table: Ranbaxy deals targeting biosimilars
Table: Sandoz biosimilars portfolio, 2011
Table: Sandoz deals targeting biosimilars
Table: Teva biosimilars portfolio, 2011
Table: Teva deals targeting biosimilars
Table: Hospira biosimilars portfolio, 2011
Table: Hospira deals targeting biosimilars
Table: Stada biosimilars portfolio, 2011
Table: Stada deals targeting biosimilars
Table: Apotex biosimilars portfolio, 2011
Table: Apotex deals targeting biosimilars
Table: Watson biosimilars portfolio, 2011
Table: Watson deals targeting biosimilars
Table: Actavis biosimilars/copy-biologic portfolio, 2011
Table: Actavis – deals targeting biosimilars
Table: Mylan deals targeting biosimilars
Table: Currency exchange rates, 2011

List of Figures

Figure: Advantages for entering the biosimilars market and external factors driving biosimilar growth
Figure: Global biosimilar sales ($m), 2007–10
Figure: 2016 sales of biologics due to face patent expiry to 2016 for the top 50 pharma companies
Figure: Deals made by the top 50 pharma companies to access biosimilars as well as enhance their biologic capabilities , 1999–2011
Figure: Competencies and challenges in biosimilars development
Figure: Strategies used by leading pharma companies to directly access biosimilars
Figure: Types of deals made by the top 50 pharma companies to access biosimilars as well as enhance their biologic capabilities, 1999–2011
Figure: Merck & Co. forecast global sales according to molecule type, 2010–16
Figure: Pfizer forecast global sales according to molecule type, 2010–16
Figure: GlaxoSmithKline forecast global sales according to molecule type, 2010–16
Figure: Biogen Idec forecast global sales according to molecule type, 2010–16
Figure: Amgen forecast global sales according to molecule type, 2010–16
Figure: Daiichi Sankyo forecast global sales according to molecule type, 2010–16
Figure: Boehringer Ingelheim forecast global sales according to molecule type, 2010–16
Figure: AstraZeneca forecast global sales according to molecule type, 2010–16
Figure: Bayer forecast global sales according to molecule type, 2010–16
Figure: Roche forecast global sales according to molecule type, 2010–16