You are leaving Medscape Education
Cancel Continue
Log in to save activities Your saved activities will show here so that you can easily access them whenever you're ready. Log in here CME & Education Log in to keep track of your credits.

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
Abseamed MEDICE Pharma GmbH & Co. KG August 2007
Epoetin zeta Silapo STADA Arzneimittel AG December 2007
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
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: Accessed February 10, 2011.


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
  • 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:

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


As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


  • Bradford R. Hirsch, MD

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


    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


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


  • Kerrin M. Green, MA

    Assistant Managing Editor, Journal of the National Comprehensive Cancer Network


    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


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

CME Reviewer(s)

  • Nafeez Zawahir, MD

    CME Clinical Director, Medscape, LLC


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

  • Sarah Fleischman

    CME Program Manager, Medscape, LLC


    Disclosure: Sarah Fleischman has disclosed no relevant financial relationships.

Accreditation Statements

    For Physicians

  • This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Medscape, LLC and JNCCN - The Journal of the National Comprehensive Cancer Network. Medscape, LLC is accredited by the ACCME to provide continuing medical education for physicians.

    Medscape, LLC designates this Journal-based CME activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Medscape, LLC staff have disclosed that they have no relevant financial relationships.

    Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]

Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 70% on the post-test.

Follow these steps to earn CME/CE credit*:

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online or printed out.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. Medscape Education encourages you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.

*The credit that you receive is based on your user profile.


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

Authors: Bradford R. Hirsch, MD; Gary H. Lyman, MD, PhDFaculty and Disclosures

CME Released: 8/4/2011

Valid for credit through: 8/4/2012, 11:59 PM EST



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)