Table 1.

Agent (Trade Name)	Mechanism	Sales Rank	2009 Sales (Billion)
Bevacizumab (Avastin)	VEGF	3	US $5.8
Rituximab (Rituxan)	CD20	4	US $5.7
Epoetin alfa (multiple)	EPO-R	6	US $5.0
Trastuzumab (Herceptin)	HER2/neu	7	US $4.9
Pegfilgrastim (Neulasta)	G-CSF	9	US $3.4
Darbepoetin alfa (Aranesp)	EPO-R	10	US $2.9

Six of the Top-10 Biologics Used in Oncology

Abbreviations: EPO-R, erythropoietin receptor; G-CSF, granulocyte colony-stimulating factor; HER2/neu, human epidermal growth factor receptor 2; VEGF, vascular endothelial growth factor.
Data from Ledford H. ‘Biosimilar’ drugs poised to penetrate market. Nature 2010;468:18–19.

Table 2.

International Generic	Trade Name of Biosimilar	Company	Date of Approval
Epoetin alfa	Epoetin alfa Hexal	Hexal AG	August 2007
Epoetin alfa	Abseamed	MEDICE Pharma GmbH & Co. KG	August 2007
Epoetin zeta	Silapo	STADA Arzneimittel AG	December 2007
Epoetin zeta	Retacrit	Hospira, Inc.	December 2007
Filgrastim	Ratiograstim	ratiopharm GmbH	September 2008
	Biograstim	CT Arzneimittel GmbH	September 2008
	Tevagrastim	Teva Pharmaceutical Industries Ltd.	September 2008
	Zarzio	Sandoz International GmbH	February 2009
	Filgrastim Hexal	Hexal AG	February 2009
	Nivestim	Hospira, Inc.	June 2010
Epoetin theta	Biopoin	CT Arzneimittel GmbH	October 2009
Epoetin theta	Eporatio	ratiopharm GmbH	October 2009

Biosimilars Related to Oncology Available in the European Union

Among biologic agents used in oncology, 2 categories (granulocyte colony-stimulating factor and erythropoietin alfa) have experienced biosimilar entry at the time of patent expiration.
Data from European Medicines Agency. European public assements reports: cancer. 2011. Available at: http://www.ema.europa.eu. Accessed February 10, 2011.

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Author(s)

Bradford R. Hirsch, MD

Department of Medicine, Duke University; Duke Cancer Center, Durham, North Carolina

Disclosures

Disclosure: Bradford R. Hirsch, MD, has disclosed no relevant financial relationships.

Gary H. Lyman, MD, PhD

Department of Medicine, Duke University; Duke Cancer Center, Durham, North Carolina

Disclosures

Disclosure: Gary H. Lyman, MD, PhD, has disclosed the following relevant financial relationships:
Receives research support from Amgen

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Kerrin M. Green, MA

Assistant Managing Editor, Journal of the National Comprehensive Cancer Network

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Disclosure: Kerrin M. Green, MA, has disclosed no relevant financial relationships.

CME Author(s)

Charles P. Vega, MD

Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine

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Disclosure: Charles P. Vega, MD, has disclosed no relevant financial relationships.

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Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

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Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

Sarah Fleischman

CME Program Manager, Medscape, LLC

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Disclosure: Sarah Fleischman has disclosed no relevant financial relationships.

CME

Biosimilars: Are They Ready for Primetime in the United States?

Authors: Bradford R. Hirsch, MD; Gary H. Lyman, MD, PhD
CME Released: 8/4/2011
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 8/4/2012, 11:59 PM EST

Start Activity

Target Audience and Goal Statement

This activity is intended for primary care physicians, oncologists, endocrinologists, nephrologists, rheumatologists, and other physicians who prescribe biologic agents.

The goal of this activity is to evaluate the potential use of biosimilar products.

Upon completion of this activity, participants will be able to:

Describe current regulation of biologic agents
Analyze the system for the approval of biosimilars in Europe
Evaluate the potential economic impact of biosimilars
Distinguish the most promising system for monitoring the quality of biosimilars

Disclosures

Author(s)

Bradford R. Hirsch, MD

Department of Medicine, Duke University; Duke Cancer Center, Durham, North Carolina

Disclosures

Disclosure: Bradford R. Hirsch, MD, has disclosed no relevant financial relationships.

Gary H. Lyman, MD, PhD

Department of Medicine, Duke University; Duke Cancer Center, Durham, North Carolina

Disclosures

Disclosure: Gary H. Lyman, MD, PhD, has disclosed the following relevant financial relationships:
Receives research support from Amgen

Editor(s)

Kerrin M. Green, MA

Assistant Managing Editor, Journal of the National Comprehensive Cancer Network

Disclosures

Disclosure: Kerrin M. Green, MA, has disclosed no relevant financial relationships.

CME Author(s)

Charles P. Vega, MD

Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine

Disclosures

Disclosure: Charles P. Vega, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

Disclosures

Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

Sarah Fleischman

CME Program Manager, Medscape, LLC

Disclosures

Disclosure: Sarah Fleischman has disclosed no relevant financial relationships.

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Abstract

The introduction of alternative versions of biologic products, also known as biosimilars, into the United States market has been gaining increasing visibility as patents for many agents are nearing expiration. Unlike generics, which are regulated under the Hatch-Waxman legislation passed in 1984, the approval process for biosimilars in the United States has not been defined. In 2004, the European Union established a regulatory pathway for these agents, and the FDA is now following suit. The economic implications are large, with $66.9 billion spent on the top 20 biologics in 2009. Of the top 10 biologics, 6 are routinely used in oncology. As the regulatory requirements are debated, several critical issues must be resolved. The most obvious is that the agents must be shown to be comparable to the original biologic they intend to replace. Knowledge of pharmacokinetic parameters alone will not be adequate, but the amount of clinical data required by the FDA remains unclear. The regulations will define the ease with which a biosimilar can be brought to market, and the associated costs of trials will influence the ultimate price of the medications. Balancing the needs of the relevant stakeholders is critical to ensure patient safety while controlling costs, improving access, and encouraging innovation. This is not an easy balance to strike. (JNCCN 2011;9:934–943)

Page 1 of 8

Background on Biosimilars

CME Information

References

References

Disclaimer

The material presented here does not necessarily reflect the views of Medscape, LLC, or companies that support educational programming on www.medscape.org. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity.

Published by Harborside Press

Table 1.

Table 2.

References

Faculty and Disclosures

Author(s)

Bradford R. Hirsch, MD

Gary H. Lyman, MD, PhD

Editor(s)

Kerrin M. Green, MA

CME Author(s)

Charles P. Vega, MD

CME Reviewer(s)

Nafeez Zawahir, MD

Sarah Fleischman

CME

Biosimilars: Are They Ready for Primetime in the United States?

Target Audience and Goal Statement

Disclosures

Author(s)

Bradford R. Hirsch, MD

Gary H. Lyman, MD, PhD

Editor(s)

Kerrin M. Green, MA

CME Author(s)

Charles P. Vega, MD

CME Reviewer(s)

Nafeez Zawahir, MD

Sarah Fleischman

Accreditation Statements

For Physicians

Instructions for Participation and Credit

Biosimilars: Are They Ready for Primetime in the United States?

Abstract

Table of Contents