Biosimilars in the US: lessons learned
The number of Biosimilar Product Development (BPD) programs has grown twofold in the recent years: from 33 in 2013 to 66 in 2016.
Regulator noticed increasing activity and summarized experience on biosimilar product development in the presentation published on the official FDA website. In this presentation, the agency listed general advice on the interaction between regulators and sponsors and content of applications and meetings. FDA encourages industry to change the focus and to focus on bio-similarity rather than on efficacy and safety in biosimilar drug studies and applications.
FDA underlines two pillars of bio-similarity definition – biological product should be “highly similar” and should not demonstrate clinically meaningful differences. The Agency also emphasizes that from the legal perspective “highly similar” and “no clinically meaningful differences” refer to related yet distinct requirements for a biosimilar.
Organization also noted a 2,5-fold growth in BSUFA (Biosimilar User Fee Act) development-phase meetings in recent three years and recommends industry to choose BPD meetings and to refer to “FDA guidance for industry on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants”.
FDA states that incomplete applications and submissions are generally wasting FDA and industry time and resources, and encourages to request a BPD Type 4 meeting as the purpose of this type of meetings is to discuss the format and content of drug application dossier.
Quantitative summarizing of recent experience predicts upcoming qualitative regulatory shift, that’s why FDA names conclusions that have been made “lessons” for itself and industry.
