How Will News of Teva’s Early Stage Trials of Biosimilar Rituximab Alter Expectations for Complex Biosimilars?

— A Webinar from Decision Resources’ Biosimilars Advisory Service

As part of our Biosimilars Advisory Service, Decision Resources is offering an exclusive webinar entitled How Will News of Teva’s Early Stage Trials of Biosimilar Rituximab Alter Expectations for Complex Biosimilars? This webinar is open ONLY to subscribers of Decision Resources’ new Biosimilars Advisory Service.

Quarterly webinars for subscribers of the Biosimilars Advisory Service offer analysis of recent major happenings in biosimilars ranging from legislative and regulatory changes to a snapshot of the competitive landscape.

Please contact us to learn how you can purchase this service and attend the webinar.

News of Teva Pharmaceuticals’ recruitment of patients with rheumatoid arthritis for a clinical trial of TL-011, a biosimilar version of Roche’s Rituxan (rituximab), confirms Teva’s intent to pursue the development of biosimilars. While it is no surprise that Teva is developing a biosimilar rituximab, what may be surprising is how far they have or have not progressed.

For this webinar, the European launch of Tevagrastim, Teva’s biosimilar filgrastim, will serve as a case study. We will look at the details of Tevagrastim’s late-stage clinical development, submission and approval, as well as its early uptake and sales in the EU. Using this information, we will propose several scenarios and revised timelines for the development of complex biosimilars, including rituximab.

This webinar, presented by Decision Resources Analyst MaryEllen Klusacek, Ph.D., will also address recent developments in biosimilars, including:

• Developments in U.S. legislation and regulation of biosimilars
  The recently passed Patient Protection and Affordable Care Act provides a framework for the approval of biosimilars, but it is clear the details of any pathway will still fall under the purview of the FDA. We will briefly outline likely FDA initiatives related to the development of a biosimilar approval pathway, as well as changes in reimbursement policies that have the potential to impact biosimilars and biologics.
• Recent advances in biosimilars regulation and pricing in the EU
  Controlling rising healthcare costs is becoming increasingly important for European nations looking to balance their budgets; many European countries are focusing on restricting drug pricing or usage as a means of achieving this goal. We will briefly discuss the influence of changes in pricing and reimbursement strategies on the maturing European biosimilars market.
• Competitive landscape
  We will highlight the emerging players in biosimilar manufacturing and drug development over the last quarter, with a focus on their expanding capabilities and emerging products.

Quarterly Webinar Registration

How Will News of Teva’s Early Stage Trials of Biosimilar Rituximab Alter Expectations for Complex Biosimilars?

June 23, 2010 at 10 a.m. U.S. Eastern Time, 4 p.m. Central European Time (Paris).

To learn how you can purchase the Biosimilars Advisory Service and attend the webinar, please contact us using the information below.

Contact Us

In North America — Keith Rourke at 781-296-2656 or krourke@dresources.com

In Europe — Kaj van Langendonck at +32-2-357-06-14 or kvanlangendonck@decisionresources.be

In Japan — Makiko Yoshimoto at +81-3-5401-2615 or makiko@dresources.jp

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