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Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!

Dutta B, Huys I, Vulto AG, Simoens S.

BioDrugs. 2019 Dec 2. doi: 10.1007/s40259-019-00395-w. [Epub ahead of print] Review.


Delivering on the Promise of Biosimilars.

Vulto AG.

BioDrugs. 2019 Dec;33(6):599-602. doi: 10.1007/s40259-019-00388-9.


The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars.

Barbier L, Declerck P, Simoens S, Neven P, Vulto AG, Huys I.

Br J Cancer. 2019 Jul;121(3):199-210. doi: 10.1038/s41416-019-0480-z. Epub 2019 Jul 1. Review.


Potential prediction of formulation performance in paediatric patients using biopharmaceutical tools and simulation of clinically relevant administration scenarios of nifedipine and lorazepam.

Van der Vossen AC, Hanff LM, Vulto AG, Fotaki N.

Br J Clin Pharmacol. 2019 Aug;85(8):1728-1739. doi: 10.1111/bcp.13956. Epub 2019 Jun 18.


Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 1-Biosimilar and Originator Infliximab in the Hospital Setting.

Moorkens E, Simoens S, Troein P, Declerck P, Vulto AG, Huys I.

BioDrugs. 2019 Jun;33(3):285-297. doi: 10.1007/s40259-019-00345-6.


Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 2-Biosimilar and Originator Etanercept in the Outpatient Setting.

Moorkens E, Simoens S, Troein P, Declerck P, Vulto AG, Huys I.

BioDrugs. 2019 Jun;33(3):299-306. doi: 10.1007/s40259-019-00346-5.


Manipulation of oral medication for children by parents and nurses occurs frequently and is often not supported by instructions.

van der Vossen AC, Al-Hassany L, Buljac S, Brugma JD, Vulto AG, Hanff LM.

Acta Paediatr. 2019 Aug;108(8):1475-1481. doi: 10.1111/apa.14718. Epub 2019 Mar 13.


Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent.

Kristensen LE, Alten R, Puig L, Philipp S, Kvien TK, Mangues MA, van den Hoogen F, Pavelka K, Vulto AG.

BioDrugs. 2018 Oct;32(5):397-404. doi: 10.1007/s40259-018-0306-1.


Use of Biosimilars in Pediatric Inflammatory Bowel Disease: An Updated Position Statement of the Pediatric IBD Porto Group of ESPGHAN.

de Ridder L, Assa A, Bronsky J, Romano C, Russell RK, Afzal NA, Hauer AC, Knafelz D, Lionetti P, Strisciuglio C, Veres G, Winter H, Wolters VM, Sladek M, Vulto AG, Dias JA; Paediatric IBD Porto group of ESPGHAN.

J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):144-153. doi: 10.1097/MPG.0000000000002141.


Policies for biosimilar uptake in Europe: An overview.

Moorkens E, Vulto AG, Huys I, Dylst P, Godman B, Keuerleber S, Claus B, Dimitrova M, Petrova G, Sović-Brkičić L, Slabý J, Šebesta R, Laius O, Karr A, Beck M, Martikainen JE, Selke GW, Spillane S, McCullagh L, Trifirò G, Vella Bonanno P, Mack A, Fogele A, Viksna A, Władysiuk M, Mota-Filipe H, Meshkov D, Kalaba M, Mencej Bedrač S, Fürst J, Zara C, Skiöld P, Magnússon E, Simoens S.

PLoS One. 2017 Dec 28;12(12):e0190147. doi: 10.1371/journal.pone.0190147. eCollection 2017.


Autologous Dendritic Cells Pulsed with Allogeneic Tumor Cell Lysate in Mesothelioma: From Mouse to Human.

Aerts JGJV, de Goeje PL, Cornelissen R, Kaijen-Lambers MEH, Bezemer K, van der Leest CH, Mahaweni NM, Kunert A, Eskens FALM, Waasdorp C, Braakman E, van der Holt B, Vulto AG, Hendriks RW, Hegmans JPJJ, Hoogsteden HC.

Clin Cancer Res. 2018 Feb 15;24(4):766-776. doi: 10.1158/1078-0432.CCR-17-2522. Epub 2017 Dec 12.


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

Vulto AG, Jaquez OA.

Rheumatology (Oxford). 2017 Aug 1;56(suppl_4):iv14-iv29. doi: 10.1093/rheumatology/kex278. Review.


Research on Biosimilars: pivotal trials and principles.

Jurczak W, Vulto AG, Amersdorffer J, Kim WS, Coiffier B.

Lancet Haematol. 2017 Sep;4(9):e409-e410. doi: 10.1016/S2352-3026(17)30152-7. No abstract available.


The Market of Biopharmaceutical Medicines: A Snapshot of a Diverse Industrial Landscape.

Moorkens E, Meuwissen N, Huys I, Declerck P, Vulto AG, Simoens S.

Front Pharmacol. 2017 Jun 8;8:314. doi: 10.3389/fphar.2017.00314. eCollection 2017.


Adoption of Biosimilar Infliximab for Rheumatoid Arthritis, Ankylosing Spondylitis, and Inflammatory Bowel Diseases in the EU5: A Budget Impact Analysis Using a Delphi Panel.

Kanters TA, Stevanovic J, Huys I, Vulto AG, Simoens S.

Front Pharmacol. 2017 May 31;8:322. doi: 10.3389/fphar.2017.00322. eCollection 2017.


Formulating a poorly water soluble drug into an oral solution suitable for paediatric patients; lorazepam as a model drug.

van der Vossen AC, van der Velde I, Smeets OS, Postma DJ, Eckhardt M, Vermes A, Koch BC, Vulto AG, Hanff LM.

Eur J Pharm Sci. 2017 Mar 30;100:205-210. doi: 10.1016/j.ejps.2017.01.025. Epub 2017 Jan 23.


Antithrombotic stewardship: a multidisciplinary team approach towards improving antithrombotic therapy outcomes during and after hospitalisation: a study protocol.

Dreijer AR, Kruip MJ, Diepstraten J, Polinder S, Brouwer R, Leebeek FW, Vulto AG, van den Bemt PM.

BMJ Open. 2016 Dec 20;6(12):e011537. doi: 10.1136/bmjopen-2016-011537.


Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies.

Moorkens E, Jonker-Exler C, Huys I, Declerck P, Simoens S, Vulto AG.

Front Pharmacol. 2016 Jun 29;7:193. doi: 10.3389/fphar.2016.00193. eCollection 2016. Review.


e-Monitoring of Asthma Therapy to Improve Compliance in children (e-MATIC): a randomised controlled trial.

Vasbinder EC, Goossens LM, Rutten-van Mölken MP, de Winter BC, van Dijk L, Vulto AG, Blankman EI, Dahhan N, Veenstra-van Schie MT, Versteegh FG, Wolf BH, Janssens HM, van den Bemt PM.

Eur Respir J. 2016 Sep;48(3):758-67. doi: 10.1183/13993003.01698-2015. Epub 2016 May 26.


Design and stability study of an oral solution of amlodipine besylate for pediatric patients.

van der Vossen AC, van der Velde I, Smeets OS, Postma DJ, Vermes A, Koch BC, Vulto AG, Hanff LM.

Eur J Pharm Sci. 2016 Sep 20;92:220-3. doi: 10.1016/j.ejps.2016.05.019. Epub 2016 May 20.


Non-adherence to inhaled corticosteroids and the risk of asthma exacerbations in children.

Vasbinder EC, Belitser SV, Souverein PC, van Dijk L, Vulto AG, van den Bemt PM.

Patient Prefer Adherence. 2016 Apr 12;10:531-8. doi: 10.2147/PPA.S92824. eCollection 2016.


Bioequivalence study of an extemporaneously prepared oral solution of amlodipine suitable for use in pediatric patients compared to commercial tablets.

van der Vossen AC, van der Velde I, van den Meiracker AH, van der Nagel BC, Koch BC, Vulto AG, Hanff LM.

Int J Clin Pharmacol Ther. 2016 Jan;54(1):65-72. doi: 10.5414/CP202449.


Ketanserin versus dihydralazine for the treatment of severe hypertension in early-onset preeclampsia: a double blind randomized controlled trial.

Bijvank SW, Visser W, Duvekot JJ, Steegers EA, Edens MA, Roofthooft DW, Vulto AG, Hanff LM.

Eur J Obstet Gynecol Reprod Biol. 2015 Jun;189:106-11. doi: 10.1016/j.ejogrb.2015.02.002. Epub 2015 Mar 10.


Understanding HIV infection for the design of a therapeutic vaccine. Part II: Vaccination strategies for HIV.

de Goede AL, Vulto AG, Osterhaus AD, Gruters RA.

Ann Pharm Fr. 2015 May;73(3):169-79. doi: 10.1016/j.pharma.2014.11.003. Epub 2014 Dec 17. Review.


Understanding HIV infection for the design of a therapeutic vaccine. Part I: Epidemiology and pathogenesis of HIV infection.

de Goede AL, Vulto AG, Osterhaus AD, Gruters RA.

Ann Pharm Fr. 2015 Mar;73(2):87-99. doi: 10.1016/j.pharma.2014.11.002. Epub 2014 Dec 12. Review.


Analysis of Spanish generic medicines retail market: recommendations to enhance long-term sustainability.

Dylst P, Vulto AG, Simoens S.

Expert Rev Pharmacoecon Outcomes Res. 2014 Jun;14(3):345-53. doi: 10.1586/14737167.2014.891442. Epub 2014 Apr 23.


Workshop on the challenges in substitution of nonbiological complex drugs.

Shah VP, Vulto AG, Mühlebach S.

Am J Health Syst Pharm. 2013 Nov 1;70(21):1879-80. doi: 10.2146/ajhp130141. No abstract available.


Prolonged influenza virus shedding and emergence of antiviral resistance in immunocompromised patients and ferrets.

van der Vries E, Stittelaar KJ, van Amerongen G, Veldhuis Kroeze EJ, de Waal L, Fraaij PL, Meesters RJ, Luider TM, van der Nagel B, Koch B, Vulto AG, Schutten M, Osterhaus AD.

PLoS Pathog. 2013;9(5):e1003343. doi: 10.1371/journal.ppat.1003343. Epub 2013 May 23.


e-Monitoring of Asthma Therapy to Improve Compliance in children using a real-time medication monitoring system (RTMM): the e-MATIC study protocol.

Vasbinder EC, Janssens HM, Rutten-van Mölken MP, van Dijk L, de Winter BC, de Groot RC, Vulto AG, van den Bemt PM; e-MATIC Study Group.

BMC Med Inform Decis Mak. 2013 Mar 21;13:38. doi: 10.1186/1472-6947-13-38.


Interchangeability, immunogenicity and biosimilars.

Ebbers HC, Crow SA, Vulto AG, Schellekens H.

Nat Biotechnol. 2012 Dec;30(12):1186-90. doi: 10.1038/nbt.2438. No abstract available.


Risk management of biosimilars in oncology: each medicine is a work in progress.

Vulto AG, Crow SA.

Target Oncol. 2012 Mar;7 Suppl 1:S43-9. doi: 10.1007/s11523-011-0188-3. Epub 2012 Jan 25. Review.


Nonlinear relationship between mycophenolate mofetil dose and mycophenolic acid exposure: implications for therapeutic drug monitoring.

de Winter BC, Mathot RA, Sombogaard F, Vulto AG, van Gelder T.

Clin J Am Soc Nephrol. 2011 Mar;6(3):656-63. doi: 10.2215/CJN.05440610. Epub 2010 Nov 18.


The impact of CYP2D6-predicted phenotype on tamoxifen treatment outcome in patients with metastatic breast cancer.

Lammers LA, Mathijssen RH, van Gelder T, Bijl MJ, de Graan AJ, Seynaeve C, van Fessem MA, Berns EM, Vulto AG, van Schaik RH.

Br J Cancer. 2010 Sep 7;103(6):765-71. doi: 10.1038/sj.bjc.6605800. Epub 2010 Aug 10.


Sildenafil exposure in neonates with pulmonary hypertension after administration via a nasogastric tube.

Ahsman MJ, Witjes BC, Wildschut ED, Sluiter I, Vulto AG, Tibboel D, Mathot RA.

Arch Dis Child Fetal Neonatal Ed. 2010 Mar;95(2):F109-14. doi: 10.1136/adc.2009.168336. Epub 2009 Nov 30.


The CYP2C19*17 genotype is associated with lower imipramine plasma concentrations in a large group of depressed patients.

Schenk PW, van Vliet M, Mathot RA, van Gelder T, Vulto AG, van Fessem MA, Verploegh-Van Rij S, Lindemans J, Bruijn JA, van Schaik RH.

Pharmacogenomics J. 2010 Jun;10(3):219-25. doi: 10.1038/tpj.2009.50. Epub 2009 Nov 3.


Inosine monophosphate dehydrogenase messenger RNA expression is correlated to clinical outcomes in mycophenolate mofetil-treated kidney transplant patients, whereas inosine monophosphate dehydrogenase activity is not.

Sombogaard F, Peeters AM, Baan CC, Mathot RA, Quaedackers ME, Vulto AG, Weimar W, van Gelder T.

Ther Drug Monit. 2009 Oct;31(5):549-56. doi: 10.1097/FTD.0b013e3181b7a9d0.


Variation in the CYP2D6 gene is associated with a lower serum sodium concentration in patients on antidepressants.

Kwadijk-de Gijsel S, Bijl MJ, Visser LE, van Schaik RH, Hofman A, Vulto AG, van Gelder T, Ch Stricker BH.

Br J Clin Pharmacol. 2009 Aug;68(2):221-5. doi: 10.1111/j.1365-2125.2009.03448.x.


Pharmacokinetic modelling of the plasma protein binding of mycophenolic acid in renal transplant recipients.

van Hest RM, van Gelder T, Vulto AG, Shaw LM, Mathot RA.

Clin Pharmacokinet. 2009;48(7):463-76. doi: 10.2165/11312600-000000000-00000.


Interpatient variability in IMPDH activity in MMF-treated renal transplant patients is correlated with IMPDH type II 3757T > C polymorphism.

Sombogaard F, van Schaik RH, Mathot RA, Budde K, van der Werf M, Vulto AG, Weimar W, Glander P, Essioux L, van Gelder T.

Pharmacogenet Genomics. 2009 Aug;19(8):626-34. doi: 10.1097/FPC.0b013e32832f5f1b.


Clinically relevant QTc prolongation due to overridden drug-drug interaction alerts: a retrospective cohort study.

van der Sijs H, Kowlesar R, Klootwijk AP, Nelwan SP, Vulto AG, van Gelder T.

Br J Clin Pharmacol. 2009 Mar;67(3):347-54. doi: 10.1111/j.1365-2125.2008.03357.x. Epub 2008 Dec 10.


Association between the CYP2D6*4 polymorphism and depression or anxiety in the elderly.

Bijl MJ, Luijendijk HJ, van den Berg JF, Visser LE, van Schaik RH, Hofman A, Vulto AG, van Gelder T, Tiemeier H, Stricker BH.

Pharmacogenomics. 2009 Apr;10(4):541-7. doi: 10.2217/pgs.09.9.


Improved assay for the nonradioactive determination of inosine 5'-monophosphate dehydrogenase activity in peripheral blood mononuclear cells.

Glander P, Sombogaard F, Budde K, van Gelder T, Hambach P, Liefeldt L, Lorkowski C, Mai M, Neumayer HH, Vulto AG, Mathot RA.

Ther Drug Monit. 2009 Jun;31(3):351-9. doi: 10.1097/FTD.0b013e31819c3f3d.


Editorial: The promise of Basel.

Vermeulen LC, Vulto AG, Zellmer WA.

Am J Health Syst Pharm. 2009 Mar 1;66(5 Suppl 3):S7. doi: 10.2146/ajhp080690. No abstract available.


The CYP2D6*4 polymorphism affects breast cancer survival in tamoxifen users.

Bijl MJ, van Schaik RH, Lammers LA, Hofman A, Vulto AG, van Gelder T, Stricker BH, Visser LE.

Breast Cancer Res Treat. 2009 Nov;118(1):125-30. doi: 10.1007/s10549-008-0272-2. Epub 2009 Feb 3.


Genetic variation in the CYP2D6 gene is associated with a lower heart rate and blood pressure in beta-blocker users.

Bijl MJ, Visser LE, van Schaik RH, Kors JA, Witteman JC, Hofman A, Vulto AG, van Gelder T, Stricker BH.

Clin Pharmacol Ther. 2009 Jan;85(1):45-50. doi: 10.1038/clpt.2008.172. Epub 2008 Sep 10.


Spinal anaesthesia with articaine 5% vs bupivacaine 0.5% for day-case lower limb surgery: a double-blind randomized clinical trial.

Dijkstra T, Reesink JA, Verdouw BC, Van der Pol WS, Feberwee T, Vulto AG.

Br J Anaesth. 2008 Jan;100(1):104-8.


Influence of the CYP2D6*4 polymorphism on dose, switching and discontinuation of antidepressants.

Bijl MJ, Visser LE, Hofman A, Vulto AG, van Gelder T, Stricker BH, van Schaik RH.

Br J Clin Pharmacol. 2008 Apr;65(4):558-64. Epub 2007 Dec 7.


Association of graded allele-specific changes in CYP2D6 function with imipramine dose requirement in a large group of depressed patients.

Schenk PW, van Fessem MA, Verploegh-Van Rij S, Mathot RA, van Gelder T, Vulto AG, van Vliet M, Lindemans J, Bruijn JA, van Schaik RH.

Mol Psychiatry. 2008 Jun;13(6):597-605. Epub 2007 Jul 31.


Five Stabilized 111In-labeled neurotensin analogs in nude mice bearing HT29 tumors.

Janssen PJ, de Visser M, Verwijnen SM, Bernard BF, Srinivasan A, Erion JL, Breeman WA, Vulto AG, Krenning EP, de Jong M.

Cancer Biother Radiopharm. 2007 Jun;22(3):374-81.


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