[HTML][HTML] Policies for biosimilar uptake in Europe: an overview

E Moorkens, AG Vulto, I Huys, P Dylst, B Godman… - PloS one, 2017 - journals.plos.org
Background Across European countries, differences exist in biosimilar policies, leading to
variations in uptake of biosimilars and divergences in savings all over Europe. Objectives …

The efficacy, safety, and immunogenicity of switching between reference biopharmaceuticals and biosimilars: a systematic review

L Barbier, HC Ebbers, P Declerck… - Clinical …, 2020 - Wiley Online Library
To date, no consensus exists among stakeholders about switching patients between
reference biological products (RPs) and biosimilars, which may have been curbing the …

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 …

Long-term intravenous treatment of Pompe disease with recombinant human α-glucosidase from milk

JMP Van den Hout, JHJ Kamphoven, LPF Winkel… - …, 2004 - publications.aap.org
Objective. Recent reports warn that the worldwide cell culture capacity is insufficient to fulfill
the increasing demand for human protein drugs. Production in milk of transgenic animals is …

Recombinant human α-glucosidase from rabbit milk in Pompe patients

H Van den Hout, AJJ Reuser, AG Vulto, MCB Loonen… - The Lancet, 2000 - thelancet.com
Pompe's disease is a fatal muscular disorder caused by lysosomal α-glucosidase deficiency.
In an open-label study, four babies with characteristic cardiomyopathy were treated with …

Enzyme replacement therapy in late‐onset Pompe's disease: a three‐year follow‐up

LPF Winkel, JMP Van den Hout… - Annals of …, 2004 - Wiley Online Library
Pompe's disease is an autosomal recessive myopathy. The characteristic lysosomal storage
of glycogen is caused by acid α‐glucosidase deficiency. Patients with late‐onset Pompe's …

Spironolactone in type 2 diabetic nephropathy: Effects on proteinuria, blood pressure and renal function

AH van den Meiracker, RGA Baggen… - Journal of …, 2006 - journals.lww.com
Objective To study the effects of addition of spironolactone to angiotensin-converting
enzyme (ACE) inhibition or angiotensin II (AngII) receptor antagonism on proteinuria, blood …

Intravenous glycyrrhizin for the treatment of chronic hepatitis C: a double‐blind, randomized, placebo‐controlled phase I/II trial

TGV Rossum, AG Vulto, WCJ Hop… - Journal of …, 1999 - Wiley Online Library
Abstract Background: In Japan, glycyrrhizin therapy is widely used for chronic hepatitis C
and reportedly reduces the progression of liver disease to hepatocellular carcinoma. The …

Glycyrrhizin-induced reduction of ALT in European patients with chronic hepatitis C

TGJ Van Rossum, AG Vulto, WCJ Hop… - Official journal of the …, 2001 - journals.lww.com
OBJECTIVE: In Japan, ALT normalization induced by long-term iv glycyrrhizin treatment
reportedly reduces the progression of liver disease to hepatocellular carcinoma in chronic …

A survey of the use of off-label and unlicensed drugs in a Dutch children's hospital

GW 't Jong, AG Vulto, M de Hoog, KJM Schimmel… - …, 2001 - publications.aap.org
Background. The treatment of pediatric patients with drugs in hospitals is being impeded by
a shortage in the availability of licensed drugs in an appropriate formulation. We have …