EGA Press Release

Friday , 03 October 2008

2nd EMEA-EGA Info Day Confirms Success of the Centralised Procedure
for Generic and Biosmilar Medicines

The Centralised Procedure is working well for both generic and biosimilar medicines, although fine-tuning is still necessary and changes in legislation will be required in the future. This is the main conclusion of the 2nd EGA-EMEA Info Day held today in London.

Thomas Lönngren, EMEA executive director, in his opening speech indicated that 2008-2009 would see significant increases in generic and biosimilar applications. He also emphasised that “biosimilars is a success story and Europe will continue to lead in the development of guidelines in this area.”

Greg Perry, EGA director general, in his opening statement welcomed yesterday’s publication by the EMEA of the significant reduced fee for duplicate applications required as a consequence of a national usage patent in the reference product. Mr Perry said, “This ends one of the major hurdles for generic and biosimilar applications in the Centralised Procedure.”

The Info Day provided an opportunity for disclosing the EGA’s long term vision for the industry. Mr Perry listed the key challenges to be addressed during the next round of legislation, namely: a) accepting different SmPCs in a single procedure in the case of usage patents, b) allowing flexibility in naming, c) revising the restrictions for using the Centralised Procedure (in order to increase access to the EEA market), and d) reducing fees for normal duplicate applications.

In his conclusion, Mr Perry called for the EMEA’s support for the “EU Biosimilar philosophy”, which is at stake in the current discussions on the WHO draft guidance on abbreviated licensing pathways for biologic therapeutic products. He also reminded his listeners of the need to open discussions on the issue of global development for biosimilar medicines. “This is very important for the sustainability of this young industry”, he said. “The acceptance of a global development programme will also lead to a reduction in unnecessary clinical trials, and to the reduced consumption of scarce industry and regulatory resources.”

“Most importantly”, he concluded, “cutting development costs will increase affordability and improve access to high quality medicines for more patients worldwide.”

<< Back

---

For further information contact the EGA on
Tel: +32 (0)2 736 84 11 - .