Scientific Justification and Policy Recommendations to the US Food and Drug Administration for Waiving Comparative Efficacy Studies. [PDF]
Pharmaceuticals (Basel)Niazi SK.
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Innovative Formulation Strategies for Biosimilars: Trends Focused on Buffer-Free Systems, Safety, Regulatory Alignment, and Intellectual Property Challenges. [PDF]
Pharmaceuticals (Basel)Bas TG.
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Biologic Drug Prices in Medicare Part B After Entry of Biosimilars to the Market.
JAMA Netw OpenAbdelaziz A +3 more
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Continuous Manufacturing of Recombinant Drugs: Comprehensive Analysis of Cost Reduction Strategies, Regulatory Pathways, and Global Implementation. [PDF]
Pharmaceuticals (Basel)Niazi SK.
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Antitrust and the Biopharmaceutical Industry: Lessons from Hatch-Waxman and an Early Evaluation of the Biologics Price Competition and Innovation Act of 2009 [PDF]
, 2010 Seamon, Matthew J
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Biosimilar insulins: Narrative review of the regulatory framework and registration studies. [PDF]
Diabetes Obes MetabHeise T, DeVries JH.
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Assessing the Comparability of Degradation Profiles Between Biosimilar and Originator Anti-VEGF Monoclonal Antibodies Under Thermal Stress. [PDF]
Pharmaceuticals (Basel)Pamukcu C, Atik AE.
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Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan. [PDF]
Pharmaceuticals (Basel)Langfelder RMB +4 more
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Scoping review of biosimilar disease-modifying antirheumatic drugs in pregnancy: evidence gaps and proposed outcome reporting framework. [PDF]
Rheumatol IntCheng V +7 more
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Development of Biosimilar Aflibercept SDZ-AFL. [PDF]
Curr Ther Res Clin ExpDodeller F +6 more
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