Pharmaceutical Technology Europe - August 2010 - (Page 11)

Perception, cost and the impact on biotech innovation We believe that all stakeholders are increasingly realising that marketed biosimilars offer comparable quality, safety and efficacy to their reference products. Indeed, this is the basis on which they were approved by the centralised European procedure. To quote Nicolas Rossignol, the (former) EC pharma division administrator: “We are confident that if a product meets all the requirements and gets a marketing authorisation from the Commission, it means that the product is as safe and effective as any other product authorised by the Commission.” In parallel, anti-biosimilar campaigns are also beginning to “lose their bite” and there is a growing understanding that biopharmaceutical originator companies also effectively create changes in their products similar to “biosimilars” when they modify their original manufacturing processes. Labelling and safety for the industry can The centralised European be up to 10 years. In biosimilar regulatory comparison to standard pathway recognises that generics, biosimilars offer existing biosimilars can less leeway for substantial and should have the price cuts because of the same INN (International high barriers to entry Non-Proprietary Name) — particularly on the Ameet Mali k Sandoz Biop harmaceutica as their reference financial side. ls product. Reference Our biosimilars are products that change through currently priced at about 30% below major manufacturing or process their reference products, but the modifications also have the same important thing to remember is INN. Provided that the mechanism of overall costs — the total savings action is equivalent for all indications, to healthcare systems at this level biosimilars should also be approved in of reduction are substantial, with the same indications as the reference one study in Germany conducted product. by the IGES Institute, projected potential savings in Germany alone of How low can biosimilars be priced +€8 billion through 2020. compared with the original? Development costs, which include Impact on biotech innovation clinical trials, for biosimilars, typically Biopharmaceuticals have equate to around $100 to 150 million revolutionised modern medicine and per product and the payback period will continue to do so, with many innovative new medicines still to come. Biosimilars manufacturers will play a vital role in driving the next “biologics revolution” by dramatically broadening patient access to affordable, high-quality medicines through innovative approaches to development, manufacturing and commercialisation of biosimilars. PTE Based on a contribution by Ameet Malik, Global Head, Sandoz Biopharmaceuticals. www.sandoz.com 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 http://www.sandoz.com

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