An Italian anti-trust regulator has launched an anti-competition probe into Samsung Bioepis, Genentech, Novartis, Biogen, and some of the companies Italian and Dutch units over alleged anti-competitive conduct.

The Autorità Garante della Concorrenza e del Mercato (AGCM) alleges that the companies coordinated their commercial strategies to delay the Italian market entry of Byooviz, a biosimilar drug based on the active ingredient ranibizumab, which is developed by Samsung Bioepsis and Biogen.

Byooviz is the biosimilar of Lucentis, a drug developed by Genentech and marketed in Italy by the Novartis Group.

Ranibizumab is used in the treatment of eye conditions including age-related macular degeneration (AMD) and diabetic macular oedema.

If the alleged conducts are confirmed, this would suggest intent to disrupt competition in the market, AGCM said.

AGCM explained that such “dilatory conducts” in the market entry of a biosimilar competing with the originator can result in negative repercussions on potential cost savings for purchases by Servizio Sanitario Nazionale, Italy's National Health Service.. This can also be detrimental to patients and taxpayers, reducing supply availability and prices, due to the average decreased cost of biosimilars compared to original branded therapies.

On 28 May, officials inspected the premises of Biogen Italia, Novartis, and other named companies on the basis that they may have elements useful to the investigation.

Inspections were conducted 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’s unit in the Netherlands.

Macular degeneration is an indication for drug development with more than 570 pipeline drugs currently active, according to GlobalData analysis.

GlobalData is the parent company of Pharmaceutical Technology.