Biosimilar Labeling Carve-Out Turned Erelzi's Psoriatic Arthritis, Plaque Psoriasis Uses Into 'Another Indication'
You may also be interested in...
Erelzi's Disappearing Indications: Biosimilar Loses Two Of Enbrel's Labeling Claims
Sandoz's request that US FDA remove psoriatic arthritis and plaque psoriasis indications from biosimilar's approved labeling appears aimed at defending against patent infringement claims brought by Amgen, legal experts say.
Sandoz’s Erelzi: Biosimilar Pediatric Labeling Strayed From Enbrel
Drug Review Profile of TNF-inhibitor etanercept-szzs examines how US FDA navigated its way around ‘inaccurate’ pediatric psoriasis labeling for the reference product, Amgen’s Enbrel, to reflect current state of the knowledge on the biosimilar’s labeling, albeit only temporarily.
Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira
Adalimumab-atto is approved for seven indications on the reference product label but lacks four others that are protected by orphan product exclusivity; launch timing is unclear due 'patent dance' litigation.