Results 81 to 90 of about 5,542 (243)

The market of biopharmaceutical medicines: A snapshot of a diverse industrial landscape [PDF]

, 2017
Background: Biopharmaceutical medicines represent a growing share of the global pharmaceutical market, and with many of these biopharmaceutical products facing loss of exclusivity rights, also biosimilars may now enter the biopharmaceutical market ...
Declerck, P.J. (Paul), Huys, I. (Isabelle), Meuwissen, N. (Nicolas), Moorkens, E. (Evelien), Simoens, S. (Steven), Vulto, A.G. (Arnold)   +5 more
core   +4 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

Recurrent Respiratory Papillomatosis Foundation Position Statement on the Management of Adults With RRP

The Laryngoscope, EarlyView.
ABSTRACT Objective With regulatory approval of HPV‐specific immunotherapy for recurrent respiratory papillomatosis (RRP) and growing experience with systemic bevacizumab, a management algorithm incorporating these medical treatments is warranted. Data Sources and Methods RRP Foundation (RRPF) Key Opinion Leaders offer a proposed management algorithm ...
Simon R. Best, Aaron D. Friedman, Clark A. Rosen, Robert T. Sataloff, Laura A. Matrka, H. Steven Sims, David E. Rosow, Nabil F. Saba, David G. Lott, Adam M. Klein, Ted Mau, Milan R. Amin, Kathryn A. Wikenheiser‐Brokamp, Scott M. Norberg, Kim McClellan, Geoffrey D. Young, Clint T. Allen, on behalf of the Recurrent Respiratory Papillomatosis Foundation   +17 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

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

Respiratory Syncytial Virus (RSV): A Comprehensive Overview From Basic Biology to Clinical Prevention and Control

Medicinal Research Reviews, EarlyView.
ABSTRACT Respiratory syncytial virus (RSV) is a common virus that causes respiratory infections, posing a serious threat, particularly to infants, the elderly, and individuals with compromised immune systems. As the leading cause of lower respiratory tract infections (LRTIs) in infants, RSV is responsible for millions of cases worldwide each year.
Jie Shi, Xiya Huang, Chunjun Ye, Yishan Lu, Yanyan Liu, Yuquan Wei, Xiawei Wei   +6 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

Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review

Frontiers in Public Health
IntroductionWhile biosimilar medicines can contribute to the sustainability of healthcare systems, their utilization rate varies across European countries.
Sara Machado, Agostinho Cruz, Pedro Lopes Ferreira, Pedro Lopes Ferreira, Carminda Morais, Carminda Morais, Rui Esteves Pimenta, Rui Esteves Pimenta   +7 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

Advancing pharmacometrics in Africa—Transition from capacity development toward job creation

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 407-419, March 2025.
Abstract Trained pharmacometricians remain scarce in Africa due to limited training opportunities, lack of a pharmaceutical product development ecosystem, and emigration to high‐income countries. The Applied Pharmacometrics Training (APT) fellowship program was established to address these gaps and specifically foster job creation for talent retention.
Goonaseelan (Colin) Pillai, Samer Mouksassi, Innocent G. Asiimwe, Craig R. Rayner, Steven Kern, Phumla Sinxadi, Paolo Denti, Eric Decloedt, Catriona Waitt, Bernhards R. Ogutu, Rik de Greef   +10 more
wiley   +1 more source