Results 221 to 230 of about 790,096 (261)
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Ranibizumab biosimilar (Oceva) – real-world experience from India (RORE study)

Expert Opinion on Biological Therapy
Background To evaluate early real-world clinical outcomes on the safety and efficacy of the ranibizumab biosimilar (Oceva, Sun Pharmaceuticals, India). Research design and methods A multicenter, retrospective, uncontrolled observational study evaluating ...
Ashish Sharma   +5 more
semanticscholar   +1 more source

Evaluation of adverse events associated with filgrastim originator and biosimilar using a spontaneous reporting system database.

Pharmazie, 2020
Biosimilar products of filgrastim have become available for improved sustainability of cancer care; however, the real-world safety profile remains unknown.
Iku Niinomi   +5 more
semanticscholar   +1 more source

Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

Generics and Biosimilars Initiative Journal, 2021
At the beginning of the COVID-19 pandemic, Ecuador was unprepared for the overwhelming number of COVID-19 cases. As the general population started to see the eff ects of the pandemic, unproven treatments and medications were sought by the population to try to ameliorate the impact of the pandemic.
Esteban Ortiz-Prado   +5 more
openaire   +1 more source

Rapid characterization of structural and functional similarity for a candidate bevacizumab (Avastin) biosimilar using a multipronged mass-spectrometry-based approach.

Drug Testing and Analysis, 2019
The ongoing shift from small molecule drugs to protein therapeutics in the pharmaceuticals industry presents a considerable challenge to generic drug developers who are increasingly required to demonstrate biosimilarity for biological macromolecules, a ...
Kerene A Brown   +3 more
semanticscholar   +1 more source

Analytical comparison of Soliris® and its biosimilar, PRK-001

, 2020
Soliris® (Eculizumab) was approved by regulatory authorities as the first drag for treatment of orphan disease, paroxysmal nocturnal hemoglobinuria, in 2007.
M. A. Zhuchenko   +8 more
semanticscholar   +1 more source

Biosimilars and Information Exchange in Australian Pharmaceutical Patent, Trade Secret and Data Exclusivity Arrangements

2022
More specifically, this thesis examines the information exchange between originator manufacturers and biosimilar manufacturers related to patents and data exclusivity, and how the information exchange affects biosimilars and biosimilar development.
openaire   +1 more source

Global Pharmaceutical Market Evolution: From Blockbuster Drugs to Biologics and Biosimilars – A Comprehensive Review

Journal of European Economic History
The global pharmaceutical industry has undergone a paradigm shift from the dominance of blockbuster small-molecule drugs to biologics and biosimilars. This transformation is driven by patent expirations, escalating research and development (R&D) costs, advancements in biotechnology, and the increasing burden of chronic diseases.
openaire   +1 more source

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