Results 51 to 60 of about 166 (149)

Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?

Neurology and Therapy, 2019
Multiple sclerosis (MS) more than any other neurological disorder has experienced a tremendous progress in available evidence-based innovator disease modifying therapies (DMT).
Victor M. Rivera
doaj   +1 more source

Perceptions towards biologic and biosimilar therapy of patients with rheumatic and gastroenterological conditions

BMC Rheumatology, 2022
Background Biologic and targeted synthetic disease modifying agents (b/tsDMARDs) have broadened the treatment landscape for autoimmune diseases particularly in patients refractory to conventional DMARDs. More recently, the introduction of biosimilars has
Thomas Khoo, Navkiran Sidhu, Franca Marine, Susan Lester, Alannah Quinlivan, Debra Rowett, Rachelle Buchbinder, Catherine L. Hill   +7 more
doaj   +1 more source

Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics

Clinical Pharmacology &Therapeutics, EarlyView.
Postmarketing safety surveillance data identify safety issues not identified in preapproval clinical trials. We describe the frequency of new safety issues overall and by labeling section and the relationship of the most commonly added safety issues with the cumulative number of prescriptions dispensed via retail pharmacies.
Ellen Pinnow, Brendan Day, Esther H. Zhou, Corinne Woods, Nana Dwumfour, Jenni Y. Lee, Ilynn Bulatao, Sanae Cherkaoui, Manish Kalaria, Sonja Brajovic, Nabila Sadiq, Farideh Sistani, Maggie Lee, Grace Chai, Gerald Dal Pan   +14 more
wiley   +1 more source

Heterogeneity in learning processes and the evolution of dynamic managerial capabilities as a response of emergence of biosimilar market: evidence from the Indian pharmaceutical industry [PDF]

Technology Analysis & Strategic Management, 2017
This paper examines heterogeneity in the response of Indian firms to the emergence of a new segment in the pharmaceutical generics market – biosimilars. The necessary diversity of the knowledge base and regulatory requirements underlying biosmilar products have created significant technological capability and market access challenges for Indian firms ...
Dinar Kale, Farah Huzair
openaire   +1 more source

Policy Networks and Policy Entrepreneurship in the EU: Explaining Structural Policy Change in Pharmaceutical Innovation Incentives and Health Technology Assessment

European Policy Analysis, EarlyView.
ABSTRACT Policy process research has excelled in explaining structural policy change within national settings, but extensions and applications to the EU level have long proven challenging for scholars. Given that the EU is currently experiencing its longest period of Treaty stability since the 1980s—having evolved into a sui generis political system ...
Vassilis Karokis‐Mavrikos
wiley   +1 more source

BIOSIMILARS IN RHEUMATOLOGY

Научно-практическая ревматология, 2017
One of the most striking achievements in the pharmacotherapy of rheumatoid arthritis (RA) and other human immunoinflammatory diseases (IIDs) late in the 20th century is associated with the design of a fundamentally new group of medications that received ...
E. L. Nasonov
doaj   +1 more source

The Efficiency of the German Healthcare System: Some Puzzling Findings

The International Journal of Health Planning and Management, EarlyView.
ABSTRACT This article examines the cost‐effectiveness of the German healthcare system from the perspective of statutory health insurance (SHI). Using data for 2011–2014—the most recent period for which consistent national inputs are available—we compare a marginal, system‐wide cost‐effectiveness ratio with the cost‐effectiveness of newly approved ...
Afschin Gandjour
wiley   +1 more source

Advances in Immunological Combination Therapy for Colorectal Cancer

iMetaMed, EarlyView.
Review the progress of combined immunotherapy for colorectal cancer. ABSTRACT Immune checkpoint inhibitors (ICIs) have been utilized extensively and shown to be therapeutically beneficial in the treatment of solid tumors in recent years. Nonetheless, considerable heterogeneity in Colorectal cancer (CRC) requires careful consideration.
Jiayue Wu, Rongbo Wen, Tianshuai Zhang, Fuao Cao, Xiaoming Zhu, Liqiang Hao, Wei Zhang, Guanyu Yu   +7 more
wiley   +1 more source

Evaluation of Methods Employed in Establishing Preclinical Similarity of Adalimumab Biosimilars

Advances in Pharmacological and Pharmaceutical Sciences
Adalimumab, marketed as Humira, is a fully humanized monoclonal antibody that blocks the activity of tumor necrosis factor-alpha and is used in treating several autoimmune disorders. As one of the top-grossing pharmaceuticals, its global sales surpassed $
Ramya Nair, Naveen Krishnan, Vasudev Shenoy, Raviraja N. Seetharam   +3 more
doaj   +1 more source

Proactive therapeutic drug monitoring of infliximab leads to treatment durability in paediatric Crohn's disease: A single‐centre Australian experience

JPGN Reports, EarlyView.
Abstract Objectives To evaluate the durability and predictors of loss of response of infliximab (IFX) over 2 years in paediatric Crohn's disease (CD) utilizing a proactive therapeutic drug monitoring (TDM) strategy. Methods A retrospective, single‐centre cohort study was conducted at The Children's Hospital at Westmead (CHW), Australia, from January ...
Cher Wei Chuah, Jessica Eldredge, Annabel Magoffin, Edward Vincent O'Loughlin, Calvin Joomann Park, Juliana Puppi, Susan Siew, Michael Stormon, Kunal Thacker, Shoma Dutt   +9 more
wiley   +1 more source