Pharmaceutical Technology Europe - August 2010 - (Page 4)

Interview with the EGA the lack of thorough comparability at all levels with an ICH standard reference product. This has led to confusion, misinterpretation of the EU biosimilar concept and to unsubstantiated fears about safety. Given the high data requirements in the EU, these products would consequently not receive approval from the European Commission (EC). The EU regulatory framework has already inspired — and is continuing to inspire — many countries and we will continue to promote these high quality and safety standards worldwide. The EU legal framework also offers the key advantage of separating patent litigation from the regulatory approval processes. By doing so, it allows timely access to competitively-priced biosimilar medicines. Do you believe pharmacovigilance legislation should be enforced to monitor safety? Pharmacovigilance rules are necessary for the protection of public health to detect, assess and prevent adverse effects of all medicinal products placed on the EU market. New improved pharmacovigilance rules have now been signed off during the Spanish Presidency between the three EU institutions (the European Parliament, the Council and the EC) and are expected to be formally adopted during Autumn 2010. These rules shall apply 18 months after publication in the Official Journal of the European Union. Because biopharmaceuticals demonstrate a greater capacity to elicit an immune reaction, all biological medicines, including biosimilars, approved after the enforcement of the new pharmacovigilance legislation will be subject to additional monitoring activities. The European Medicines Agency, with the member states, will set up a list of products subject to additional monitoring. This list will include the names and active substances of future products that contain a new active substance as well as any future biological product, but other products may also be added to the list. There will also be an electronic link to the product information and the summary of the risk management plan (RMP). These products will have a black symbol in their product information and a standard sentence that invites the reporting of all adverse events. Any product specific additional monitoring activity will be listed in the RMP. The new pharmacovigilance legislation also contains a provision stipulating that “Member States shall make sure, through the methods of collecting information and where necessary through follow-up of suspected adverse reaction reports, that all appropriate measures are taken to identify any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of a suspected adverse reaction; with due regard to the name of the medicinal product [as approved] and the batch number”. Do you believe that concerns relating to the reproduction of biotechnology products are justified? Yes, the immunogenicity concerns in relation to biopharmaceuticals are justified for the reasons outlined above; however, the concerns should not be overstated, used or misused to undermine biotechnology products in general, or biosimilar medicines in particular. The basic principle underlying the development of a biosimilar product is comparability with the reference product, as assessed through a process known as a “comparability exercise”. This is a critical concept that has evolved in order to perform comparisons between different versions of any new biological products under development. Data provided by such comparisons must show that no significant differences 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