Biosimilar Labeling Carve-Out Turned Erelzi's Psoriatic Arthritis, Plaque Psoriasis Uses Into 'Another Indication'
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Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.
Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.
FDA Guides On Adding Biosimilar Indications
Sponsors may submit supplemental applications for additional indications in advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.