Articles on Follow-On Biologics

See below for PDFs of the original bills, summary information, and other resources regarding this legislation. Visit the eForum to voice your opinion.  Also, please read the International Society on Thrombosis and Haemostasis official Recommendations on Biosimilar Low-Molecular-Weight Heparins

The Proposed Approval Pathway for ‘Biosimilars’ and its Potential
Implications for Various Stakeholders
by Alaap B. Shah, Benjamin S. Martin and Lee H. Rosebush November 2009

Low-Molecular-Weight Heparins: Patient Safety and Clinical Data Requirements for Follow-on "Generic" Biologic Compounds-Highlights of a Roundtable
Supplement to Chest Physician, The Newspaper of the American College of Chest Physicians

Guideline on Non-Clinical and Clinical Development of Similar Biological Medicinal Products Containing Low-Molecular-Weight-Heparins
European Medicines Agency

Regulatory Guidelines Update Generic Low Molecular Weight Heparins. Assumed Requirements of the European Medicinal Agency (EMEA)
Wolfram Raake, Munich, Germany

Current EMEA Position on Biosimilars: Slide Presentation
Wolfram Raake, Munich, Germany

Recommendations on biosimilar low-molecular weight heparins
Journal of Thromboses and Hemostases

SASAT (South Asian Soceity on Atherosclerosis and Thrombosis): White paper – Proposal of Regulatory Guidelines for Generic Low-Molecular Weight Heparins (LMUHS)
Evi Kalodike, MD, PhD and Wendy Leong, PharmD, MBA

 

Congressional and Senatorial Bills:

Comparison of the Biosimilars Legislation Proposed by Henry Waxman and Anna Eshoo, US House of Representatives, and Charles Schumer, US Senate
Walter Jeske and Craig M. Jackson New Dems Backs Eshoo/Inslee Proposal to Create Pathway for Approval of "Follow-On" Biologics
New Democrat Coalition

Avoiding no man's land: Potential unintended consequences of follow-on biologics
Deloitte Consulting, LLP

Comparison of Biosimilar/Biogenerics Bills
Fish and Richardson

The Follow-on Biologics Debate and the June 2009 FTC Report on Follow-on Biologic Drug Competition
Thomas H. Wintner, Client Advisory, Edwards Angell Palmer & Dodge

Congressional Bill: "Licensure Pathway for Biosimilar Biological Products"
Amendment: July 2009, Proposed by Representatives Escho, Insee, and Barton Senate Bill : "Pathway fo rthe Licensure of Biosimilar Biological Products, to Promote Innovation in the Life Sciences"
Amendment No. 297: July 2009, Proposed by Senators Enzi, Hatch, and Hagan

H.R. 1427: "Promoting Innovation and Access to Life-Saving Medicine Act"
Introduced by United States Representative Henry Waxman

S. 726: "Promoting Innovation and Access to Life-Saving Medicine Act"
Introduced by United States Senator Charles Schumer

H.R. 5629: "Pathway for Biosimilars Act"
Introduced by United States Representative Anna Eshoo

 

Posters on Follow-On Biologics Presented at ISTH2009 in Boston:

Fibrin Clot Formation Differs in the Presence of Branded and Biosimilar Enoxaparins

J.M. Walenga, C. Adiguzel, O. Iqbal, D. Hoppensteadt, W. Jeske, J. Cunanan, and M. Bakhos, Cardiovascular Institute, Loyola University Medical Center, Maywood, IL, USA

Immunogenicity of Low Molecular Weight Heparins and Their Biosimilars
J.M. Walenga D. Hoppensteadt, J. Cunanan, C. Adiguzel, O. Iqbal, W.P. Jeske, M. Prechel, and M. Bakhos Cardiovascular Institute, Loyola University Medical Center, Maywood, IL, USA

Differential Thrombin Generation Inhibition by Branded and Generic Low Molecular Weight Heparins (LMWHs) as Studied by Using Fluorescence Based Kinetic Method
Adiguzel, Cafer(1); Litinas, Evangelos(1);Cunanan, Josephine(1); Hoppensteadt,Debra(1); Walenga, Jeanine(2), Fareed, Jawed(1). 1 Pathology, 2Cardiovascular Institute, Loyola University Medical Center, Maywood, IL, , USA