Due to high levels of interest and feedback, the FDA is extending the comment period for the much anticipated draft guidance “Labeling for Biosimilar Products; Draft Guidance for Industry; Availability” that was first released on April 4, 2016. The Agency is now accepting comments through August 2, 2016
On June 15, 2016, AIFA (the Italian Medicines Agency) published a “Second Concept Paper” on the use of biosimilars within the National Health System (NHS). The document is intended to start a discussion that should eventually lead to an amended or new version of the agency’s Position Paper of 28 March 2013 on the same […]
The draft guidance asserts that including data from biosimilarity studies will not be useful for health care practitioners, and that a description of the clinical data that supported the safety and efficacy of the reference product should be included instead.
The guideline states that biosimilars can only be compared to either authorized biologics, approved with a complete data package in India, or biologics that have been approved in an ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) country.