Results 111 to 120 of about 5,542 (243)

Cohort Study on Drug Survival and Tolerability of Adalimumab Biosimilar Transitioning: Pharmaceutical Properties Do Matter

Clinical Pharmacology & Therapeutics
There are no clinically meaningful differences between bio‐originators (BO) and their biosimilars (BS) in safety and efficacy. However, differences in pharmaceutical properties, such as volume and excipient, can occur. This study aimed to compare outcomes between patients transitioning from the modernized adalimumab BO (0.4 mL/no ...
Amy C.D. Peeters, Maike H.M. Wientjes, Wieland D. Müskens, David F. Ten Cate, Laura C. Coates, Bart J. F. van den Bemt, Noortje van Herwaarden, Alfons A. den Broeder   +7 more
openaire   +1 more source

Pharmacokinetic, Safety, and Immunogenicity Similarity of High‐ and Low‐Concentration Formulations of Adalimumab Biosimilar ABP 501, Adalimumab‐Atto

Pharmacology Research &Perspectives, Volume 14, Issue 2, April 2026.
Consistent with previously demonstrated similarity of biosimilar ABP 501 (adalimumab‐atto) with adalimumab reference product, this study in healthy adults demonstrates the pharmacokinetic, safety, and immunogenicity similarity of a high‐concentration formulation (100 mg/mL) of ABP 501 with the original 50mg/mL formulation.
Vincent Chow, Muhan Zhou, Daniel T. Mytych, Alexander Colbert, Mieke Jill Miller, Iwona Wala, Ahad Sabet, Waldemar Radziszewski   +7 more
wiley   +1 more source

Pharmaceutical policies in a crisis? Challenges and solutions identified at the PPRI Conference [PDF]

, 2016
In October 2015, the third international Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference was held in Vienna to foster discussion on challenges in pricing and reimbursement policies for medicines.

core   +1 more source

Microneedle Technology in Psoriasis Management: Mechanistic Insights, Technological Innovation, Clinical Progress, and Challenges

Advanced Healthcare Materials, Volume 15, Issue 10, 13 March 2026.
This review explores the evolving role of microneedle systems in psoriasis management, highlighting their potential for enhanced drug delivery, diagnosis, and disease monitoring. It also discusses unmet clinical needs for psoriasis management and technical challenges, while outlining strategic directions to advance microneedle integration into routine ...
Fatma Moawad, Yasmine Ruel, Roxane Pouliot, Davide Brambilla   +3 more
wiley   +1 more source

Review on lipegfilgrastim

International Journal of Nanomedicine, 2015
Maja Gasparic, Sophie LeymanTeva Pharmaceuticals Europe BV, European Headquarters, Amsterdam, the NetherlandsHaving read the original Hoggatt et al article1 and the corrigendum published online on August 27, 2015,2 we do not consider the description of ...
Gasparic M, Leyman S
doaj  

A Review on Quantitative Process Analytical Technology for Continuous Downstream Processing of Monoclonal Antibodies

Biotechnology and Bioengineering, Volume 123, Issue 3, Page 564-581, March 2026.
ABSTRACT The competition in the biopharmaceutical market is increasing due to the market entry of biosimilars and rising costs in research and development of new drugs. Hence, continuous manufacturing gained significant attention due to its potential in reducing production cycle times and costs, as well as the possibility of real‐time release testing ...
Mariana Carvalho, Ana Cruz, Cees Haringa, Marcel Ottens, Marieke Klijn   +4 more
wiley   +1 more source

The introduction of biosimilars of low molecular weight heparins in Europe: a critical review and reappraisal endorsed by the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV)

Thrombosis Journal, 2017
Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane® and Inhixa®, biosimilars of the Low Molecular Weight Heparin (LMWH) enoxaparin.
Davide Imberti, Marco Marietta, Hernan Polo Friz, Claudio Cimminiello   +3 more
doaj   +1 more source

Evolution of Biosimilar Medicines on the Romanian Pharmaceutical Market

Acta Pharmaceutica Hungarica, 2021
Emese Sipos, Emőke Rédai, Ibolya Fülöp   +2 more
openaire   +1 more source

Development of a High‐Throughput LC–MS/MS Method for Simultaneous Quantification of Four Therapeutic Monoclonal Antibodies in Human Serum: Application in Clinical Therapeutic Drug Monitoring

Biomedical Chromatography, Volume 40, Issue 3, March 2026.
ABSTRACT Monoclonal antibody (mAb) therapies have revolutionized cancer treatment, significantly improving patient outcomes. However, the pharmacokinetics (PK) and pharmacodynamics (PD) of mAbs exhibit considerable variability due to nonlinear kinetics and individual differences, highlighting the need for therapeutic drug monitoring (TDM).
Yuan Yao, Guang‐Yao Huang, Ting‐Ting Wu, Ting‐Fei Tan, Feng‐Mei Hu, Chao Huang, Shan Gao, An‐Ping Guo, Jun‐Ping Wang   +8 more
wiley   +1 more source

Net Present Value Impact of FDA’s Phase 3 Waivers on Monoclonal Antibody Biosimilar Development

Biologics: Targets & Therapy
Ranjit Ranbhor,1 Priyanka Kulkarni2 1Business Development, Portfolio and Patents, Odin Pharmaceuticals LLC, Somerset, NJ, USA; 2Feliciano School of Business, Montclair State University, Montclair, NJ, USACorrespondence: Ranjit Ranbhor, Business ...
Ranbhor R, Kulkarni P
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