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Administration, Other income and Other expense include items related to setup costs for Novartis Business Services; Other income also includes an income related to the portfolio transformation; Other expense also includes other restructuring expenses.

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These comparability “exercises” rarely entailed clinical trials, and they never required switching studies between pre- and post-change product.

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Suitability of a candidate positive control reagent should be demonstrated by confirming equivalent reactivity in a ligand-binding assay with the biosimilar and reference products: this could be achieved by titrating the positive control antibody signal in the screening assay format with increasing amounts of competing antigen (biosimilar versus reference product); the inhibition curves for the biosimilar and reference product competing antigens should be essentially overlapping.

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In September 2014, Colombia released new regulations for the approval of biosimilars in the country.

Patient recruitment has been completed for both Phase III pivotal trials of anti-PDGF therapy OAP030 (pegpleranib, also known as Fovista) with Lucentis for the treatment of neovascular age-related macular degeneration (nAMD).

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The National Affiliation of Boards of Pharmacy (NABP) estimates there are at the very least four hundred Internet sites shelling out prescriptions within the United States. Nobody is aware of what number of of those on-line pharmacies exist worldwide.
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