A Randomized, Double‐Blind, Parallel Controlled, Single‐Dose Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of the Infliximab Biosimilar CMAB008 and the Reference Product in Healthy Chinese Male Subjects
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1135
Abstract: This study aimed to evaluate the pharmacokinetics (PK), safety, and immunogenicity of the infliximab biosimilar CMAB008 compared to the reference product (Remicade) in healthy Chinese male subjects to provide the basis for the similarity evaluation… read more here.
Keywords: safety immunogenicity; time; reference; concentration ... See more keywords
Converging Generic Drug Product Development: Bioequivalence Design and Reference Product Selection
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DOI: 10.1007/s40262-020-00912-z
Abstract: Different regulatory agencies provide criteria for selecting a reference product for bioequivalence (BE) studies. In most cases, the criteria vary from one regulatory agency to another, and, consequently, the generic companies often have to repeat… read more here.
Keywords: bioequivalence; product selection; product; reference product ... See more keywords
A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) Adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST)
Sign Up to like & getrecommendations! Published in 2022 at "Expert Opinion on Investigational Drugs"
DOI: 10.1080/13543784.2022.2035359
Abstract: ABSTRACT Background This study (ALVOPAD FIRST) assessed bioequivalence, safety, and immunogenicity of AVT02, an adalimumab biosimilar, compared with reference product adalimumab (EU- and US-approved Humira®). Methods Healthy subjects (N = 392) were randomized 1:1:1 to… read more here.
Keywords: reference product; safety; bioequivalence; study ... See more keywords
Biosimilar insulin concepts
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Diabetes"
DOI: 10.1111/1753-0407.13267
Abstract: Insulin use has dramatically increased over the past 30 years, in part because of the increasing realization of its role in the treatment of type 2 diabetes (T2D) (Figure 1A). Worldwide, the prevalence of type… read more here.
Keywords: insulin analogs; biosimilar insulin; insulin; reference product ... See more keywords
SAT0173 Switching from reference product etanercept to the biosimilar sb4 in a real-life setting: follow-up of 147 patients
Sign Up to like & getrecommendations! Published in 2017 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/annrheumdis-2017-eular.4391
Abstract: Background The etanercept biosimilar SB4 was introduced in Sweden in early 2016. SB4 has been shown in a randomized controlled trial to be equivalent to its etanercept reference product (ERP) in terms of efficacy and… read more here.
Keywords: sb4; treatment; biosimilar sb4; reference product ... See more keywords
SP0014 THE LATEST NEWS ON BIOSIMILARS TREATMENT
Sign Up to like & getrecommendations! Published in 2019 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/annrheumdis-2019-eular.8512
Abstract: Biologic medications have revolutionized the treatment of many rheumatologic diseases, but their high cost often limits patient access to these effective treatments. Biosimilars are legitimate copies of biopharmaceuticals, which no longer are protected by patent,… read more here.
Keywords: reference; treatment; cost; biologic medications ... See more keywords
Comparative Study of Brand and Generics Ciprofloxacin Tablets Available in the Saudi Market
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DOI: 10.14227/dt300223pgc12
Abstract: Introduction : Ciprofloxacin is a fluoroquinolone class of antibiotics with broad-spectrum antibacterial activity. Biowaiver studies of generic ciprofloxacin products can be used to establish bioequivalence with the reference product. Methods : The experiments are carried… read more here.
Keywords: saudi arabia; comparative study; study brand; brand generics ... See more keywords
A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?
Sign Up to like & getrecommendations! Published in 2017 at "Journal of managed care & specialty pharmacy"
DOI: 10.18553/jmcp.2017.23.12.1234
Abstract: BACKGROUND Biosimilars undergo an abbreviated licensure pathway called 351(k), which was created by the Biologics Price Competition and Innovation Act of 2009. This approval process is different from the 351(a) pathway for original biologic approval… read more here.
Keywords: clinical studies; reference product; evidence; united states ... See more keywords
BIOEQUIVALENCE STUDY OF AZELNIDIPINE 16 MG TABLET TO EVALUATE PHARMACOKINETIC PROFILE OF SINGLE DOSE IN HEALTHY, ADULT, HUMAN VOLUNTEERS UNDER FASTING CONDITION
Sign Up to like & getrecommendations! Published in 2021 at "International Journal of Applied Pharmaceutics"
DOI: 10.22159/ijap.2021v13i4.41331
Abstract: Objective: The present study's objective is to conduct a comparative bioavailability study with a special emphasis on the test product's bioequivalence using a standard reference product as a comparator. Methods: Before initiating the bioequivalent study,… read more here.
Keywords: study; product; auc0; bioequivalence ... See more keywords
A Validated IVRT Method to Assess Topical Creams Containing Metronidazole Using a Novel Approach
Sign Up to like & getrecommendations! Published in 2020 at "Pharmaceutics"
DOI: 10.3390/pharmaceutics12020119
Abstract: An IVRT method was developed and validated to confirm its reproducibility, precision, sensitivity, selectivity, accuracy, robustness, and reliability. A novel approach was used to demonstrate the appropriateness of the IVRT method to accurately assess “sameness”… read more here.
Keywords: novel approach; creams containing; reference product; method ... See more keywords
Validation of a Size-Exclusion Chromatography Method for Bevacizumab Quantitation in Pharmaceutical Preparations: Application in a Biosimilar Study
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DOI: 10.3390/separations6030043
Abstract: In May 2019, the Food and Drug Administration (FDA) proposed a quality range (QR) method for the comparative analytical assessment in biosimilar studies. In this process, several reference product lots are necessary, selected from a… read more here.
Keywords: validation size; lots variation; reference product; method ... See more keywords