Pharmaceutical Technology Europe - August 2010 - (Page 8)

Latest EU guidelines dissected The European Medicines Agency (EMA) adopted the Guideline on Similar Biological Medical Products in 2005. This guideline still provides overarching guidance, but since its introduction the EMA has developed a range of more specific guidelines that provide details for different product classes of biosimilars. Interferon alpha Low molecular weight heparins To date, guidelines have been adopted for biosimilar insulin, somatropin, granulocyte colony-stimulating factor, erythropoietin and, most recently, low molecular weight heparins (LMWHs). Unlike other biosimilar guidelines, the guideline concerning LMWHs specifically states that conventional pharmacokinetic studies are not required because of the problems in developing bioanalytical assays for LMWHs; instead, pharmacodynamic assessment of anti-FXa and anti-FIIa is recommended. to indicate that The EMA has published a extrapolation from reflection paper that lays one clinical indication down key considerations to another could be for developing biosimilar made in the case of interferon alpha products. this product class, too. The paper suggests Indeed, based on the a range of animal mechanism of action pharmacodynamic of these products, Peter Gaskin Aptuit Consu models that might this should be more lting be suitable for the straightforward than assessment of interferon alpha and for interferon alpha products where explains that a 4-week toxicity study the mechanisms of action can be less in Syrian Golden hamsters should be well understood. sufficient to meet requirements. The paper also provides useful advice on MAbs clinical study design and, importantly, A concept paper released in October suggests that extrapolation from one 2009 indicated that a draft biosimilars clinical indication to another may be guideline for monoclonal antibodies possible if mechanistically justifiable. (MAbs) would be developed in 2010, and included a number of areas that Erythropoietins should be addressed. Interestingly, Recently, a revision to the EMA’s the paper also introduced the guideline on the non-clinical and possibility that development clinical development of biosimilar pathways may be different for erythropoietins was also made MAbs with immunomodulatory and cytotoxic modes of action. One of the other key aspects mentioned in the paper was immunogenicity, reflecting the size, complexity and extent of post-translational modification of this class of products relative to the simpler classes of biologics developed as biosimilars to date. Further, the EMA has released concept papers for guidelines relating to interferon beta and follicle stimulation hormone biosimilar products. The deadline for comments on these papers passed in June of this year. PTE Based on a contribution by Peter Gaskin, Principal Consultant at Aptuit Consulting. To read the full version of this article, go to www.pharmtech.com/gaskin www.aptuitconsulting.com 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.pharmtech.com/gaskin http://www.aptuitconsulting.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