Results 81 to 90 of about 5,574 (244)

Exploring market dynamics of biological including biosimilar treatments for retinal diseases in Europe: An interrupted time‐series analysis

Acta Ophthalmologica, EarlyView.
Abstract Purpose To assess the impact of biosimilar ranibizumab and on‐patent faricimab market entry on pricing and utilization trends and describe national variation in off‐label bevacizumab use in Europe. Methods Interrupted time series analysis of quarterly sales data (Q1 2018–Q2 2024) in 11 European countries evaluated ranibizumab utilization and ...
Elif Car, Isabelle Huys, Steven Simoens, Arnold G. Vulto   +3 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

Regulation of Innovation Under Follow-On Biologics Legislation: FDA Exclusivity as an Efficient Incentive Mechanism [PDF]

, 2010
As part of its broader effort to reform the American health care system, Congress has recently enacted legislation that creates a statutory pathway for FDA approval of generic "follow-on" biologics products.
Morgan, Maxwell R.
core   +2 more sources

Biosimilar drugs – automatic substitution regulations review. Polish ISPOR chapter’s Therapeutic Programs and Pharmaceutical Care (TPPC) task force report

Journal of Health Policy & Outcomes Research, 2014
Objectives: Review of the EU regulations concerning substitution of biological products with biosimilar products . Methods: The TPPC task force has checked the approach to automatic substitution by WHO, at the EMA level and in countries across European Union.
Drozd, Mariola, Baran-Lewandowska, Izabela   +1 more
openaire   +2 more sources

Novel approaches for drug development against chronic primary pain: A systematic review

British Journal of Pharmacology, EarlyView.
Abstract Chronic primary pain (CPP) persisting for more than 3 months, associated with significant emotional distress without any known underlying cause, is an unmet medical need. Traditional or adjuvant analgesics do not provide satisfactory pain relief for a great proportion of these patients.
Valéria Tékus, Éva Borbély, Andreas Goebel, Ralf Baron, Zsófia Hajna, Zsuzsanna Helyes   +5 more
wiley   +1 more source

A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48)

Arthritis Research & Therapy
Background Equivalent efficacy and comparable pharmacokinetic, immunogenicity, and safety profiles of the biosimilar BAT1806/BIIB800 and reference tocilizumab (TCZ) in participants with moderate-to-severe rheumatoid arthritis (RA) have been reported up ...
Xiaomei Leng, Piotr Leszczyński, Slawomir Jeka, Shengyun Liu, Huaxiang Liu, Malgorzata Miakisz, Jieruo Gu, Lali Kilasonia, Mykola Stanislavchuk, Xiaolei Yang, Yinbo Zhou, Qingfeng Dong, Marian Mitroiu, Janet Addison, Mourad F. Rezk, Xiaofeng Zeng   +15 more
doaj   +1 more source

A Critical Look at Innovation Profile and Its Relationship with Pharmaceutical Industry [PDF]

, 2017
Background: The pharmaceutical sector undertakes extensive research and development (R&D). Pharmaceutical industries have continued to launch an appreciable number of new medicines, different pharmaceutical formulations, new indications and other ...
Acurcio, FdeA, Dias, CZ, Dias, EM, Godman, B, Guerra Jnr, AA, Martin, A, Prata, WM, Silvestre, RG   +7 more
core   +1 more source

Impact of adalimumab treatment on impairment of non‐professional activities in psoriasis patients

JDDG: Journal der Deutschen Dermatologischen Gesellschaft, EarlyView.
Summary Background and objectives Psoriasis can result in reduced quality of life, work productivity loss, and a significant restriction in non‐professional activities. This study investigates the effects of long‐term treatment with adalimumab regarding work ability, non‐professional activities, and health‐related quality of life in a large real‐word ...
Georgios Kokolakis, Sandra Philipp, Thomas Mosch, Björn Fritz, Robert Sabat   +4 more
wiley   +1 more source

Efficacy, safety, and immunogenicity of biosimilars compared with the biologic etanercept in patients with rheumatoid arthritis: a systematic review and meta-analysis

Systematic Reviews
Background Biosimilar etanercept presents itself as an innovative therapeutic opportunity for inflammatory and autoimmune diseases, however, its efficacy, safety, and immunogenicity in relation to the reference biological agent for the treatment of ...
Aurélio Matos Andrade, Juliana da Motta Girardi, Erica Tatiane da Silva, Jakeline Ribeiro Barbosa, Daniella Cristina Rodrigues Pereira   +4 more
doaj   +1 more source

Biosimilar filgrastim treatment patterns and prevention of febrile neutropenia: a prospective multicentre study in France in patients with solid tumours (the ZOHé study)

BMC Cancer, 2018
Background The ZOHé study was a prospective, non-interventional, multicentre study in France to assess the use of biosimilar filgrastim Zarzio® (Sandoz filgrastim) in routine clinical practice in patients at risk of neutropenia-inducing chemotherapy (CT).
Henri Roché, Jean-Christophe Eymard, Abderraouf Radji, Alain Prevost, Rafik Diab, Michele Lamuraglia, Ravaka-Fatoma Soumoudronga, Isabelle Gasnereau, Alain Toledano   +8 more
doaj   +1 more source