EGA Press Release

Wednesday, 23 April 2009

TOWARDS GLOBAL DEVELOPMENT AND MONOCLONAL ANTIBODIES
| TAKING BIOSIMILAR MEDICINES TO THE NEXT LEVEL |

In his opening address to the 7th EGA Symposium on Biosimilar Medicines today in London, EGA Director General Greg Perry congratulated the industry and EU medicines regulatory authorities for further consolidating and developing the EU’s ‘biosimilar thinking’ during 2008. “Promoting the use of biosimilar medicines”, he said, “is vital to increasing patient access to life-saving medicinal care and to ensuring the sustainability of EU healthcare systems.”

Perry told his audience, “The EU continues to lead worldwide in the development of new guidelines and is now taking biosimilar medicines to the next level by organising a workshop on biosimilar monoclonal antibodies (mAbs).” Separately, Suzette Kox, EGA Director of Scientific Affairs, explained that “The applicability of the biosimilarity concept to mAbs is indeed triggering great interest. Highly sophisticated analytical and validation tools are available today to assist in the characterisation of mAbs. In addition, modern manufacturing technologies allow the consistent production of recombinant proteins with highly specific predefined quality characteristics. Our industry is definitely taking up this new challenge.”

To date, thirteen marketing authorisations, based on six developments, have been granted for biosimilar medicines and the positive trend of biosimilar applications continues in 2009. The 67% success rate of approvals illustrates the high standards and the outstanding level of scientific evaluation in place which instils confidence in the EU regulatory system. The EU ‘biosimilar philosophy’ is also inspiring guideline development in many countries.

2008-2009 are indeed seeing extensive work on guidelines worldwide. This move nourishes the EGA’s vision of a global development approach for biosimilar medicines. This goal is inspired by ethical and scientific principles as well as economical considerations, and will have a significant positive therapeutic impact for thousands of patients living with life-threatening and chronic diseases.

In the meantime, much is still needed in the market place, Mr Perry explained. “While we observe positive developments, our industry faces continuous hurdles erected by certain interested parties.” He said some roadblocks were recently highlighted by the ‘French Mutuality’ in their public submission to the European Commission on the pharmaceutical sector inquiry where they cite the “denigration campaigns put in place by originator companies with the aim of maintaining an aura of suspicion around biosimilars.” The key therefore to ensuring biosimilar market pathways is to reinforce the confidence of patients and healthcare professionals in the EU approval process for biosimilar products and in the EU’s strong and efficient pharmacovigilance system while increasing awareness and information.

“For the sake of Europe’s patients, Mr Perry said, “we — industry and regulators alike — have a shared responsibility to challenge misinformation, misinterpretations and misperceptions collectively.” He also insisted that “this effort should include increased active support of the EU’s ‘biosimilar philosophy’ by EU and national authorities.”

In conclusion, Mr Perry launched a call to create continued ‘headroom for competition’. “Sustainability of EU pharmaceutical healthcare”, he said, “requires a strong, competitive and financially vibrant EU generic and biosimilar medicines industry. To achieve this will require the development of a consistent global approach to regulating this new type of medicines, which in turn will improve availability, affordability and access to treatment in the EU and worldwide in line with the European Commission Communication of December 2008 on Safe, Innovative and Accessible Medicines: A Renewed Vision of the Pharmaceutical Sector.”

Greg Perry's Presentation
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