Mylan, Others: Deem Insulin Biosimilar, Interchangeable Simultaneously

Biosimilar maker Mylan and several experts in the field say FDA should allow insulin products shown to be biosimilar to reference products to simultaneously get interchangeability status, arguing insulins are less complex than most other biologic products and should be regulated more like small-molecule drugs. Several presenters at an FDA meeting Monday (May 13) on insulin biosimilars also said concerns about immunogenicity risks from insulin products, including some expressed by FDA, are over-hyped, as immunogenicity is not clinically significant in...