Apotex Citizen Petition Seeks to Heighten Regulatory Requirements for Biosimilar Competition

Apotex Citizen Petition Seeks to Heighten Regulatory Requirements for Biosimilar Competition


Last week, Apotex filed a Citizen Petition requesting that FDA "take certain actions to ensure a robust approval process" for proposed biosimilars to Amgen's Neulasta . Among its requests, Apotex asks that FDA require each biosimilar applicant to conduct comparative clinical efficacy studies, including pharmacokinetics, pharmacodynamics, and immunogenicity studies, in at least one intended patient population, rather than conducting such studies only in healthy subjects.



from Biotech News