Pharmaceutical Technology Europe - August 2010 - (Page 6)

The biosimilars market today and tomorrow Last year, the global market for biological products exceeded $125 billion, accounting for 17% of the total market for pharma/ biopharma products. However, biosimilars last year only generated around $89 million in sales, with Sandoz’s omnitrope accounting for the vast portion of those sales (33% market share). On a more positive note, growth in sales between June 2008 and June 2009 increased by a remarkable 200%. Meanwhile, some Indian companies are using their experiences within the deregulated markets to produce dossiers and products suited for regulated markets. Certain R&Dbased companies are also eyeing biosimilars as an opportunity for future growth; for instance, Merck The future market landscape has launched Merck Bioventures Sandoz is currently the global market to develop biosimilars. Many leader in biosimilars sales, but Teva companies have embarked on and Hospira are also developing partnering and licensing deals in a range of biosimilar products. the area of biosimilars, but it will be those that already have inTable 1: Current market share value for marketed biosimilars by house capabilities who will country in Q2 2009. be in the best Human growth Erythropoetin Granulocyte hormone position. The cost hormone (hGH) (EPO) colony stimulating of acquisition in factor (G-CSF) this field is high and US 6.6% 0 0 with the current Japan 0 0 0 limited penetration France 12.5% 2.0% 3.8% of biosimilars there Germany 5.1% 52.1% 31.0% is no guarantee of a Italy 15.3% 0.2% 18.5% return on investment Alan Sheppa Spain 1.4% 1.6% 7.1% rd IMS Health in the short-to midUK 1.0% 0.9% 24.0% term. Europe is by far the most advanced in terms of biosimilars approvals, but market penetration naturally varies considerably between the EU countries, with Germany accounting for the greatest market share in Europe and, indeed, worldwide (Table 1). Forecasting biosimilar sales is complex because of various factors including the imprecise classification of a biosimilar and pricing policies of the originator resulting in the use of the brand in place of the biosimilar. Some estimates show the market growing from $66 million in 2008 to $2.3 billion in 2015. Others see sales exceeding $5.6 billion in 2013. Whatever the forecast, there remains a $50 billion potential for biosimilars. PTE Based on a contribution by Alan Sheppard, Principal, Thought Leadership, Global Generics at IMS Health. The full version of this article can be read in the September issue of Pharmaceutical Technology Europe. 1 CONTENTS 9 TAKING ON REGULATORS 3 EGA INTERVIEW 10 LAUNCHING A BIOSIMILAR 6 THE BIOSIMILARS MARKET 11 IMPACT ON INNOVATION 7 SWOT ANALYSIS 13 BIOSIMILARS NOT COMPELLING

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - August 2010

Pharmaceutical Technology Europe - August 2010
Table of Contents
The Changing Landscape for Biosimilars
Interview with The European Generic Medicines Association
The Biosimilars Market Today and Tomorrow
A SWOT Analysis of the Biosimilars Market
Latest EU Guidelines Dissected
Taking On the Regulators: Is It Worth It?
Launching and Commercialising Biosimilars
Perception, Cost and the Impact on Biotech Innovation
Clinical and Cost Considerations of Developing a Biosimilar
True Biosimilars Do Not Offer a Compelling Business Case
What is Hindering the Uptake of Biosimilars

Pharmaceutical Technology Europe - August 2010