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Biosimilars in Oncology: Update Bulletin
[Feb 2016]
[Published by FirstWord Pharma]

Published by FirstWord Pharma: 01 Feb 2016 | 304 | In Stock

Introduction

Introduction


new KOL insights on the latest events that have the potential to shape the oncology biosimilars market. Topics covered include opinions about data from Sandoz’s PROTECT 1 and PROTECT 2 studies which both compared the safety and efficacy of LA-EP2006 (a proposed pegfilgrastim biosimilar) to Amgen’s Neulasta in patients with breast cancer; the regulatory filing of Celltrion’s proposed rituximab biosimilar, CT-P10, to the European Medicines Agency (EMA), and the concerns KOLs have in relation to the potential for indication extrapolation from the rheumatology to oncology settings; the potential impact of The Centers for Medicare & Medicaid Services’s (CMS) final rule on how it plans to reimburse for biosimilars covered under Medicare Part B in the US.


Key Questions Answered in this Update Bulletin:


  • Does the data from the PROTECT 1 and PROTECT 2 studies for Sandoz’s LA-EP2006 (a proposed pegfilgrastim biosimilar) support its wider use in the oncology setting, and will payers or switching be the key driver of product utilisation?

  • Will Amgen’s Neulasta OnPro kit slow down the adoption of pegfilgrastim biosimilars in the US, or will cost-effective biosimilars prompt payers to stop its reimbursement?

  • How concerned are KOLs that Celltrion’s proposed rituximab biosimilar, CT-P10, could be awarded key oncology indications by extrapolation, and how could this effect product adoption?

  • Will the attraction of a cost-effective rituximab biosimilar prompt payers to stop the reimbursement of subcutaneous MabThera in Europe, or will the product’s dosing and patient convenience benefits continue to support access?

  • Where will new biosimilar reimbursement rules have the most impact in the US; academic or community oncology clinics? Moreover, do KOLs believe that new CMS rules will drive down prices to unsustainable levels and cause the biosimilars market in the US to fail?

  • Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update.

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    for Biosimilars in Oncology: Update Bulletin [Feb 2016] [Published by FirstWord Pharma]

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    FirstWord Pharma

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