Swiss regulatory agency, Swissmedic, approved a targeted (anti-HER2) oncology drug developed by a US headquartered cancer-focused biotechnology company in Switzerland. This is the first product approved by Swissmedic under the FDA Initiative – Project Orbis.  Notably, this is also the first approval of this innovative breast cancer drug outside of the US.

SFL Regulatory Affairs & Scientific Communication GmbH (SFL) supported with the preparation of the Marketing Authorization Application (MAA) dossier and submitted to Swissmedic, utilizing the novel Project Orbis process. Swissmedic approved the product four months after SFL’s MAA submission and less than one month after FDA approval in the US, highlighting the benefits of this new regulatory process to facilitate rapid access to innovative new drugs for Swiss patients.

SFL is excited to continue supporting companies in their endeavors to develop and provide access to transformative medicines.

Contact the SFL Team and explore how SFL can serve you across the entire product life cycle and/or act as marketing authorization applicant and MAH in Switzerland and the EU and conduct submissions to FDA, PMDA and Health Canada and other authorities.