Humira Biosimilar Interchangeability: The Race Begins
Executive Summary
Boehringer Ingelheim announcement is first public disclosure of interchangeability trial since US FDA draft guidance was released.
You may also be interested in...
Are US Interchangeability Studies Worth It?
Payers are driving the selection of reference products or biosimilars, creating an ‘artificial interchangeability’ unlikely to be affected by the actual regulatory designation, industry reps say; former FDA commissioner Scott Gottlieb says misinformation campaigns around biosimilar and interchangeable products may lead to enforcement by the FDA and Federal Trade Commission.
Biosimilar Switching Studies May Not Be Worth Effort For US Interchangeability, Sponsors Say
Payers are driving the selection of reference products or biosimilars, creating an ‘artificial interchangeability’ unlikely to be affected by the actual regulatory designation, industry reps say; former FDA commissioner Scott Gottlieb says misinformation campaigns around biosimilar and interchangeable products may lead to enforcement by the FDA and Federal Trade Commission.
Biosimilars: US FDA Expecting More Applications, Fewer Applicants
Preparing biosimilar applications still takes as much time as it would for an original BLA, FDA says.