The European Medicines Agency (EMA) adopts two draft guidelines as part of the regulatory approval process for certain biosimilar medicinal products. Public comments on both are requested by May 31, 2011. The guidelines address “similar biological medicinal products containing monoclonal antibodies” and “immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use.”
The Food and Drug Administration issues a notice asking patient and consumer advocacy groups, health care professionals and academic experts to tell the agency if they intend to participate in “consultation meetings relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under the Public Health Service Act.” Notification of intention to participate is requested by January 10, 2011.
