Delivery of biologics: Topical administration

RJ Kulchar, R Singh, S Ding, E Alexander, KW Leong… - Biomaterials, 2023 - Elsevier
Biologics are unaffordable to a large majority of the global population because of
prohibitively expensive fermentation systems, purification and the requirement for cold chain …

The process defines the product: what really matters in biosimilar design and production?

AG Vulto, OA Jaquez - Rheumatology, 2017 - academic.oup.com
Biologic drugs are highly complex molecules produced by living cells through a multistep
manufacturing process. The key characteristics of these molecules, known as critical quality …

The high cost of prescription drugs: causes and solutions

S Vincent Rajkumar - Blood cancer journal, 2020 - nature.com
Global spending on prescription drugs in 2020 is expected to be~ $1.3 trillion; the United
States alone will spend~ $350 billion 1. These high spending rates are expected to increase …

Combining precision radiotherapy with molecular targeting and immunomodulatory agents: a guideline by the American Society for Radiation Oncology

RG Bristow, B Alexander, M Baumann… - The Lancet …, 2018 - thelancet.com
The practice of radiation oncology is primarily based on precise technical delivery of highly
conformal, image-guided external beam radiotherapy or brachytherapy. However …

Assessing the immunogenicity of biopharmaceuticals

C Pineda, G Castañeda Hernández, IA Jacobs… - BioDrugs, 2016 - Springer
Biopharmaceuticals have the potential to raise an immunogenic response in treated
individuals, which may impact the efficacy and safety profile of these drugs. As a result, it is …

Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents

B Vezér, Z Buzás, M Sebeszta… - Current medical research …, 2016 - Taylor & Francis
Background The quality of biologicals, including biosimilars, is subject to change as a result
of manufacturing process modifications following initial authorization. It is important that such …

The effect of customers' perceived value of retail store on relationship between store attribute and customer brand loyalty: Some insights from Malaysia

SR Nikhashemi, AK Tarofder, SS Gaur… - Procedia Economics and …, 2016 - Elsevier
Customer brand loyalty has been an important area for practitioners in retailing industry due
to various developments in the increasingly competitive environment. The objective of the …

21st century pharmacovigilance: efforts, roles, and responsibilities

PJ Pitts, H Le Louet, Y Moride, RM Conti - The Lancet Oncology, 2016 - thelancet.com
In an era when the number of expedited and conditional review pathways for newly
available brand-name drugs and biosimilar medicines to treat serious and life-threatening …

[HTML][HTML] The global need for a trastuzumab biosimilar for patients with HER2-positive breast cancer

K Blackwell, J Gligorov, I Jacobs, C Twelves - Clinical breast cancer, 2018 - Elsevier
Trastuzumab improves survival outcomes for patients with HER2-positive (HER2+) breast
cancer, yet not all such women receive this important therapy. Trastuzumab was approved …

Safety of biologics, including biosimilars: perspectives on current status and future direction

Y Ingrasciotta, PM Cutroneo, I Marcianò, T Giezen… - Drug safety, 2018 - Springer
In recent years, marketing of highly innovative and costly biologics improved the
management of high-burden diseases such as autoimmune diseases, cancers, and chronic …