专题:Biosimilars and Bioanalytical Methods

This cluster of papers focuses on the immunogenicity of biosimilar therapeutics, including the validation of bioanalytical methods for assessing immunogenicity, the impact of manufacturing changes on immunogenicity, and the clinical outcomes and safety of switching from reference biologics to biosimilars. The use of dried blood spots for bioanalysis and the regulatory considerations for biosimilars are also prominent topics within this cluster.
最新文献
Follitropin alfa biosimilars: unfounded doubts on the road to reproductive care

letter Full Text OpenAlex

Methodological concerns and clinical relevance: a critical appraisal of the meta-analysis on biosimilars versus originator follitropin alfa in ART

letter Full Text OpenAlex

Abnormal coagulation indicators associated with β-lactamantibacterial drug: a pharmacovigilance study based on the FAERS database.

article Full Text OpenAlex

Pricing and reimbursement of off-patent medicines dispensed in community pharmacies

review Full Text OpenAlex

Financial Feasibility of Developing Sustained-Release Incrementally Modified Drugs in Thailand’s Pharmaceutical Industry: Mixed Methods Study

article Full Text OpenAlex

Structure and function of therapeutic antibodies approved by the US FDA in 2024

article Full Text OpenAlex

Comparative effectiveness and safety of biosimilars versus reference biologics in rheumatoid arthritis during treatment initiation: a systematic review of real-world evidence

review Full Text OpenAlex

OP0079 Clinical, Cellular Kinetics, Pharmacodynamics and Biomarker Data Up to 12 Months After YTB323 (Rapcabtagene Autoleucel), a Rapidly Manufactured CD19 CAR-T Therapy, From an Open-Label, Phase 1/2 Study in Severe Refractory SLE

article Full Text OpenAlex

OP0171 INTERIM REPORT ON POST-MARKETING SURVEILLANCE OF AVACOPAN, A C5A RECEPTOR ANTAGONIST, FOR MICROSCOPIC POLYANGIITIS AND GRANULOMATOSIS WITH POLYANGIITIS-1ST REPORT

article Full Text OpenAlex

Simultaneous Determination of Atezolizumab and Bevacizumab by LC–MS/MS in Rat Plasma and Its Application to a Pharmacokinetic Study

article Full Text OpenAlex

近5年高被引文献
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update

article Full Text OpenAlex 1183 FWCI241.39

Artificial Intelligence in Pharmaceutical Technology and Drug Delivery Design

review Full Text OpenAlex 523 FWCI25.462

FDA approves 100th monoclonal antibody product

review Full Text OpenAlex 444 FWCI14.426

The past, present, and future of antibiotics

review Full Text OpenAlex 419 FWCI15.619

Biopharmaceutical benchmarks 2022

article Full Text OpenAlex 341 FWCI32.231

Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future

review Full Text OpenAlex 281 FWCI5.425

Targeted Drug Delivery — From Magic Bullet to Nanomedicine: Principles, Challenges, and Future Perspectives

review Full Text OpenAlex 270 FWCI10.058

Optimization of therapeutic antibodies by predicting antigen specificity from antibody sequence via deep learning

article Full Text OpenAlex 248 FWCI30.613

How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment

review Full Text OpenAlex 246 FWCI12.719

A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions

review Full Text OpenAlex 241 FWCI13.976