Ref. Ares(2015)5702133 - 09/12/2015
Ref. Ares(2016)6036878 - 20/10/2016
TTIP Meeting with EGA and Fresenius on Generic pharmaceuticals
09/12/2015
Participants:
,
,
TRADE)
(European Generics Association),
(Fresenius)
Summary:
Industry noted strong support for TTIP and active communication work being carried
out by Fresenius CEO across Germany. A list of press articles/public statements on
support to TTIP was provided. EGA has also been active in all TTIP stakeholder
events and civil society meetings.
Industry inquired about state of play of EU generics paper. COM informed that the
paper is in final phase of consultation and is expected to be sent to the US soon.
Biosimilars – industry noted that biosimilars name does not need to have a qualifier as,
in their opinion, that qualifier creates confusion. EGA provided comments to US FDA
(Notice and Comment procedure) and suggested that same approach as the one taken
in the EU (i.e. non qualifier) is adopted.
GMP – Industry is following up with interest GMP works and would like to know
when FDA will be in a position to make its determination. COM noted that work is
ongoing and that there is expectation that by beginning of 2016 the next steps in the
process are defined.