Global ETD Search
Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
Results
Showing 1 to 9 of 9 for “"Biosimilars"”.
-
Biosimilars: A New Look on Process Innovation and the Impact of Competitive Dynamics
… in attempt to lower the costs of biologics. Biosimilars may be viewed as a “pure” or distinct type of process innovation completely separate from product innovation due to the Regulatory requirements and this novel phenomenon allows, perhaps for the first time, process innovation to be …
-
A comprehensive guide to the three biosimilar markets (Europe, US, Japan) and the regulatory pathways
… this space to enter. Biologic generics, termed biosimilars or follow-on biologics, are more difficult to evaluate due to the complex nature of the molecule and the variables involved in the development and manufacturing process. This research seeks to understand the current debate in the …
-
Brokering strategic partnerships between Asian and western biopharmaceutical companies in the global biologics market : assessment of capabilities of Asian participants in the biologics contract manufacturing organization marketplace
… the biologics market faces the threat of biosimilars (biogenerics or follow-on biologics). With the advent of expected changes in the US government healthcare policy, a number of companies will be facing competition from biosimilars in the near term. Mitigating the impact of the threat of …
-
Approvals, Utilization, and Cost of Biologics for the Treatment of Rheumatoid Arthritis
… in the TNFi classification, and authorized 19 biosimilars for five bDMARDs. After standardization, the trend revealed a significant increase in the costs of TNFi bDMARDs and a substantial decrease following FDA authorization of biosimilars for infliximab, rituximab, and adalimumab. The annual …
-
MOLECULAR ROLES OF HSP27 IN IMPROVING MONOCLONAL ANTIBODY PRODUCTION OF CHO CELLS
… EXPANDING MONOCLONAL ANTIBODIES (MAB) AND BIOSIMILARS. THERE ARE OPPORTUNITIES TO EXPLORE THE USE OF ENGINEERED CHO CELL LINES WITH IMPROVED RECOMBINANT BIOLOGICS CAPABILITIES. HEAT SHOCK PROTEIN 27 (HSP27) WAS REPORTED TO BE HIGHLY EXPRESSED IN HUMAN CELLS AND HAVE ANTI-CYTOTOXIC …
-
Novel Bayesian Adaptive Clinical Trial Designs In Early Phases
… version to an innovator's biologic drug product; biosimilars are close, but not exact copies of biologic drugs already on the market. Guidelines for statistical methods to establish biosimilarity remain nonspecific because of the newness of biosimilars. It is therefore of high urgency to develop …
-
Achieving business and operational excellence in the pharmaceutical industry
… and drug failures together with the threat of biosimilars and decreasing R&D productivity are creating challenges for research driven pharmaceutical companies. With future revenue growth uncertain, pharmaceutical companies must focus on cost reduction to sustain the profit margins needed to …
-
Anti-vascular endothelial growth factor in ophthalmology
… anti-VEGF therapy has dawned with the arrival of biosimilars and biobetters in the market.
-
Eficacia y seguridad del biosimilar ABP 501 (Adalimumab) comparado con biosimilar CT-P13 (Infliximab) en pacientes adultos con artritis reumatoide. Revisión sistemática
Introducción: No existe evidencia científica de estudios comparadores entre biosimilares, que demuestren la seguridad y eficacia, siendo esto relevante para que clínicos y aseguradores se sientan respaldados en el momento de adquirir y prescribir este tipo de moléculas. En Colombia al tratarse de …