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Biosimilar Labeling Carve-Out Turned Erelzi's Psoriatic Arthritis, Plaque Psoriasis Uses Into 'Another Indication'

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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advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.

Biosimilars: US FDA Proposes Streamlined Pathway For Indication Carve-Ins

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advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.

The Future Of US Biosimilars Litigation: Method-Of-Use Patents And ‘Dance’ Obligations

Expect plenty of litigation over what constitutes infringement of a method-of-use patent even when the protected indication is not found on a biosimilar’s labeling, a panel of legal experts said at the recent BIO meeting; another area of unsettled law is the extent to which a biosimilar sponsor has satisfied the information-exchange provisions of the BPCIA ‘patent dance.’

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