As previously reported, in February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize FYB202, a ustekinumab biosimilar of Janssen’s STELARA, in key global markets after successful regulatory approvals. The European Medicines Agency accepted Formycon’s Marketing Authorization Application for FYB202 on September 29, 2023.
It was recently reported that the Regional Court Munich issued a preliminary injunction that prevents Formycon from producing FYB202 in Germany. According to the report, Janssen has a Supplementary Protection Certificate (SPC) in Germany that protects STELARA until July 20, 2024. Formycon sought to manufacture FYB202 in Germany prior to expiration of the SPC pursuant to a waiver that permits manufacture of a biosimilar drug for export to a country outside the European Union (EU) where the SPC protection does not exist. According to the report, “Formycon intends to produce the biosimilar FYB202 in Germany in order to export it to third countries and to enter the EU market immediately following the SPC’s expiry.” Janssen argued that Formycon’s waiver was deficient because it did not include the marketing authorization number for at least one country for export in which Formycon had marketing authorization and in which the SPC does not apply. Formycon argued that such authorization number does not have to be provided in the waiver and can instead be provided as soon as it becomes available. The Court agreed with Janssen and issued a preliminary injunction prohibiting Formycon from producing FYB202 in Germany for export.