There is a great interest from global companies who are developing biosimilars to pursue interchangeability designation for commercialization of their products in the US. An interchangeability designation will not only allow the substitutability at the pharmacy level without the intervention of a health care provider but the first sponsor who is able to garner interchangeability designation will also receive 12 months of marketing exclusivity. This paper will highlight our current understanding of FDA expectations with regards to demonstrating interchangeability.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1177/2168479018755702 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies.
Expert Opin Biol Ther
December 2024
Hexal AG (A Sandoz company), Holzkirchen, Germany.
Background: To support an interchangeability designation for Sandoz adalimumab biosimilar (GP2017), antidrug antibody (ADA) signal-to-noise (S/N) ratios were assessed in the GP2017 ADACCESS trial to directly assess potential changes in immunogenicity.
Research Design And Methods: ADACCESS was a 51-week trial in patients with moderate-to-severe plaque psoriasis that included patients treated continuously with reference adalimumab (cH), and patients who experienced four switches between reference adalimumab and GP2017 (H2H). ADAs were measured every 6 weeks during the switching phase using an electrochemiluminescence assay.
Reexamining the role of subspecies in clinical and experimental studies.
Gut Microbes
October 2024
Division of Biomaterial and Biomedical Sciences, School of Dentistry, Oregon Health & Science University (OHSU), Portland, OR, USA.
Article Synopsis
- - The Gram-negative anaerobic species began as a harmless part of the human mouth but is now seen as a significant pathogen linked to various oral and non-oral diseases.
- - It was historically divided into four subspecies, thought to be equally harmful, but recent research shows varying pathogenic potentials among these subspecies.
- - This review explores the history of these subspecies and highlights recent findings to improve understanding for future research in clinical and lab settings.
Purpose: To evaluate and compare the repeatability of corneal densitometry (CD) measurements obtained using both an anterior-segment optical coherence tomography (AS-OCT) device and a Scheimpflug camera system, while also assessing the level of agreement. The study also sought to investigate the correlation of CD with age, gender, and central corneal thickness (CCT) in normal eyes.
Methods: CD measurements were obtained using the Casia 2 and the Pentacam AXL Wave.
Insulin Access Enhancement in India: Expert Views on Integrating Interchangeable Biosimilar Insulin Glargine.
Cureus
May 2024
Medical Affairs, Mankind Pharma Ltd., Navi Mumbai, IND.
Achieving and maintaining optimal glycemic targets is the fundamental goal of the management of diabetes. However, failure of oral antidiabetic drugs (OADs) to sustain the targeted glycemic levels in individuals with progressing disease often requires initiation of insulin therapy. This article consolidates the expert opinions of 377 doctors who participated in 34 advisory board meetings held digitally (n=23) and in person (n=11) across India.
View Article and Find Full Text PDFA multiscale modeling framework for Scenario Modeling: Characterizing the heterogeneity of the COVID-19 epidemic in the US.
Epidemics
June 2024
Laboratory for the Modeling of Biological and Socio-technical Systems, Network Science Institute, Northeastern University, Boston, MA, USA; Institute for Scientific Interchange Foundation, Turin, Italy. Electronic address:
Article Synopsis
- The Scenario Modeling Hub (SMH) initiative uses a multi-model approach to predict epidemic scenarios in the US, including a new multiscale model that incorporates county-level data for detailed projections of COVID-19 cases, hospitalizations, and deaths.
- The LEAM-US model divides the US into 3142 counties and integrates factors like vaccination, mobility, and interventions, allowing for an in-depth understanding of COVID-19's impact across states.
- The study also highlights the emergence and spread of the SARS-CoV-2 Alpha variant, revealing significant spatial and temporal variations and illustrating how the multiscale model can effectively capture the pandemic's complexity.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!