I868 - Italian Competition Authority: investigation launched against eight undertakings for anticompetitive agreement in the market for the active principle ranibizumab
PRESS RELEASE
The undertakings involved are Samsung Bioepis co. Ltd., Samsung Bioepis NL B.V., Biogen Inc., Biogen Italia S.r.l., Genentech Inc., Novartis AG, Novartis Europharm Ltd. and Novartis Farma S.p.A. Inspections were carried out in Italy and in the Netherlands.
The Italian Competition Authority has launched an investigation against Samsung Bioepis co. Ltd., Samsung Bioepis NL B.V., Biogen Inc., Biogen Italia S.r.l., Genentech Inc., Novartis AG, Novartis Europharm Ltd. and Novartis Farma S.p.A. to ascertain an alleged anticompetitive agreement in the market for the active ingredient ranibizumab, intended for the treatment of important eye diseases.
In particular, the AGCM alleges the existence of a coordination of the commercial strategies among these undertakings with a view to delaying the entry in the Italian market of Byooviz, a biosimilar drug based on the active principle ranibizumab, which is developed and marketed by the Samsung Bioepis and Biogen groups. Byooviz is the biosimilar of Lucentis, itself developed by Genentech and marketed in Italy by the Novartis Group.
These conducts, if confirmed, would also reveal the existence of a distortion of competitive dynamics such as to artificially limit competition on the merits.
In the pharmaceutical sector, such dilatory conducts in the market entry of a biosimilar competing with the originator causes a negative repercussion on the possible savings for purchases by the National Health Service, as well as a detriment to patients and taxpayers in terms of breadth of supply and lower prices. Indeed, biosimilars are generally marketed at a significantly lower cost than their originators.
On May 28, the Authority’s officials carried out inspections at the premises of Biogen Italia S.r.l., Novartis Farma S.p.A. and other undertakings deemed to be in possession of elements useful to the investigation, with the assistance of the Special Antitrust Unit of the Italian Financial Police (Guardia di Finanza). The Dutch Competition Authority (Autoriteit Consument & Markt) conducted parallel inspections at the premises of Samsung Bioepis NL B.V.
Rome, 6 June 2024