Review
Chemistry, Medicinal
Xin Zhou, Zhuo Chen, Xinling Bi
Summary: Biologic drugs have revolutionized the treatment of psoriasis and rheumatological diseases, with biosimilar agents showing similar structure and function to originator products at a considerably lower cost. Approvals of adalimumab biosimilars by US FDA and EMA have expanded access to biologic therapies, with guidance on interchangeability and real-life practices still evolving.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Review
Ophthalmology
Seenu M. Hariprasad, Richard P. Gale, Christina Y. Weng, Hans C. Ebbers, Mourad F. Rezk, Ramin Tadayoni
Summary: Biological therapies have revolutionized disease treatment, but their higher cost can limit patient access and treatment length. The development and approval of biosimilars offer a more affordable treatment option without compromising efficacy.
OPHTHALMOLOGY AND THERAPY
(2022)
Article
Pharmacology & Pharmacy
Anurag S. Rathore, James G. Stevenson, Hemlata Chhabra
Summary: Biosimilar medicines have revolutionized healthcare access by providing improved and cost-effective life-saving treatments. Regulatory bodies worldwide have guidelines in place to streamline the approval process for biosimilars, which are biologic drugs that enter the market after the expiration of a reference molecule's patent. This article emphasizes the importance of comparative clinical studies during biosimilar development, as demonstrated in case studies from the EMA and the FDA.
EXPERT OPINION ON DRUG SAFETY
(2021)
Article
Chemistry, Physical
Nathan A. Mahynski, Harold W. Hatch, Matthew Witman, David A. Sheen, Jeffrey R. Errington, Vincent K. Shen
Summary: By combining statistical mechanical principles with biased sampling techniques, it is possible to predict the thermodynamic properties of systems more accurately and achieve precise estimates across a wide range of conditions. These extrapolations significantly increase the amount of accurate information that can be extracted from simulations, providing data for data-intensive algorithms.
MOLECULAR SIMULATION
(2021)
Review
Oncology
Julien Taieb, Enrique Aranda, Sherif Raouf, Helen Dunn, Dirk Arnold
Summary: Biosimilars, highly similar biological medicines to licensed reference products, can reduce the risk of drug shortages by offering treatment alternatives, increasing patient access to medication, and lowering healthcare costs. The approval process involves stringent regulatory pathways, including in vitro, in vivo, and clinical studies, to demonstrate equivalence to the reference product without clinically meaningful differences.
CLINICAL COLORECTAL CANCER
(2021)
Article
Biotechnology & Applied Microbiology
Victor L. Van de Wiele, Reed F. Beall, Aaron S. Kesselheim, Ameet Sarpatwari
Summary: The abundance of biologic drug patents in the United States has caused delays in the availability of biosimilars.
NATURE BIOTECHNOLOGY
(2022)
Article
History & Philosophy Of Science
Timo Freiesleben, Thomas Grote
Summary: This paper provides a conceptual analysis of the term robustness in machine learning and aims to develop a common language to integrate different strands of robustness research. By defining robustness as relative stability, the paper captures various sub-types of robustness and distinguishes it from adjacent key concepts in machine learning.
Article
Pharmacology & Pharmacy
Smritie Sheth, Laxmikant Vashishta, Rohit Goyal, Anurag Rathore, Narendra Chirmule
Summary: Biosimilars have provided an opportunity for global access to affordable medicines over the past two decades. The development process involves robust analytical and functional comparability, equivalent pharmacokinetic profile, and demonstrating lack of any meaningful clinical differences. Standardized processes and adherence to regulatory requirements in Asia are essential for enabling cost-effective development of biosimilars.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Pharmacology & Pharmacy
Ruquan You, Sebastian Weber, Bruno Bieth, Marc Vandemeulebroecke
Summary: This paper describes the innovative pediatric development strategy of secukinumab in psoriasis. By leveraging experience and regulatory openness to innovative quantitative approaches, the pediatric development of secukinumab was substantially accelerated.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2022)
Article
Mathematics, Applied
Claude Brezinski, Michela Redivo-Zaglia
Summary: The aim of this paper is to propose a general theoretical framework for extrapolation and prediction of sequences in a vector space. Specific cases are studied and recursive algorithms for implementing some of the procedures are discussed. Possible extensions of this work are also mentioned.
JOURNAL OF COMPUTATIONAL AND APPLIED MATHEMATICS
(2022)
Review
Chemistry, Multidisciplinary
Aayushi S. Ditani, Pragyan Paramita Mallick, Neelima Anup, Vishakha Tambe, Suryanarayana Polaka, Pinaki Sengupta, Kuldeep Rajpoot, Rakesh K. Tekade
Summary: Biosimilars are biologics that are clinically identical to a reference standard, particularly in terms of strength, purity, and safety. A significant portion of biosimilars are developed for cancer treatment. This review article discusses various aspects of biosimilars, including their market accessibility, recent clinical trial outcomes, safety profiles, regulatory approval requirements, and associated challenges.
JOURNAL OF CONTROLLED RELEASE
(2021)
Review
Pharmacology & Pharmacy
Gillian R. Woollett, Joseph P. Park, Jihyun Han, Byoungin Jung
Summary: Understanding the core requirements and timelines of biosimilar development is crucial to improving its efficiency. The potential of pharmacodynamic biomarkers in enhancing biosimilar development and regulatory approval is promising but requires further discussion on motivation, feasibility, and regulatory risks. Pharmacokinetic studies have already established their comparative value in detecting subtle differences between two products.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Geochemistry & Geophysics
Kees Wapenaar, Sjoerd de Ridder
Summary: The propagator matrix and Marchenko focusing function are closely related concepts that can be transferred and learned from each other, enhancing the capabilities in handling subsurface models.
Review
Gastroenterology & Hepatology
Anna M. Buchner, Yecheskel Schneider, Gary R. Lichtenstein
Summary: Biological therapy targeting tumor necrosis factor-alpha has become crucial in treating patients with inflammatory bowel disease, but high costs limit accessibility. Biosimilars offer the potential to reduce expenditures and increase availability, providing more options for patients.
AMERICAN JOURNAL OF GASTROENTEROLOGY
(2021)
Article
Biodiversity Conservation
Mattia Brambilla, Diego Rubolini, Ojan Appukuttan, Gianpiero Calvi, Dirk Nikolaus Karger, Primoz Kmecl, Tomaz Mihelic, Thomas Sattler, Benjamin Seaman, Norbert Teufelbauer, Johannes Wahl, Claudio Celada
Summary: Identifying climate refugia is crucial for the conservation of high-elevation bird species in the European Alps. The study identified approximately 15,000 km(2) of refugia, of which 44% are currently designated as protected areas. These refugia play a vital role in safeguarding Alpine high-elevation species and habitats.
GLOBAL CHANGE BIOLOGY
(2022)
