Italian Competition Authority Investigates Alleged Effort by Novartis, Samsung Bioepis, Others to Delay Launch of Biosimilar Version of Ranibizumab
- 07/06/2024
- News
The Italian Competition Authority (Autorità Garante della Concorrenza e del Mercato - AGCM) began an investigation into alleged arrangements between Biogen, Genentech, Novartis, and Samsung Bioepis to delay the launch on the Italian market of Byooviz®, a biosimilar version of Lucentis®. Both biological medicines have ranibizumab as an active substance and are indicated for the treatment of several eye conditions, including neovascular (wet) age-related macular degeneration (AMD) and visual impairment due to diabetic macular oedema.
The case started at the request of the Italian medicines agency (Agenzia Italiana del Farmaco) which was surprised to see that Byooviz® had failed to enter the Italian market even though the medicine had ostensibly satisfied all the regulatory requirements for an extensive period of time. AGCM noted that a three-party licensing agreement involving Biogen, Samsung Bioepis, and Genentech had the characteristics of a three-way market sharing arrangement which allowed Biogen and Samsung Bioepis to enter the US market before the expiry of relevant patents, while Genentech maintained monopoly rights for the benefit of Novartis, its licensee in Europe, well beyond the expiry of the relevant patent rights with regard to Lucentis®.
According to AGCM, the arrangement, if proven to exist, harms the health service, the patients and the taxpayers, because it artificially reduces the supply of medicines, while keeping prices high (which typically come down with the advent of biosimilar medicines). AGCM plans to conclude its inquiry by 30 September 2025.
If proven, the case would offer a variation on more traditional pay-for-delay schemes in that the “payment” made by Genentech to Biogen and Samsung Bioepis to keep Byooviz® away from the Italian market came in the form of an entry ticket to the US market for Byooviz® despite the existence of blocking patents.
The case is also noteworthy because several accused parties have been involved in anticompetitive efforts to thwart off-label prescriptions of Avastin® for the treatment of AMD for the benefit of Lucentis®. This has led to enforcement action against Genentech, Novartis and Roche in a series of Member States, including Belgium, Italy, and France (see, Van Bael & Bellis Life Sciences News and Insights of 25 January 2023, 9 September 2020, and 24 January 2018).
The attached documents are Italian and English versions of an AGCM press release of 6 June 2024 and of an AGCM decision of 21 May 2024 to open a competition inquiry which gave rise to on-premise inspections in both Italy and the Netherlands on 28 May 2024
