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Surveyed EU5 Pulmonologists Expect that Relvar, the First Once-Daily LABA/ICS FDC, Will Experience Healthy Uptake in Asthma
Date:7/24/2014

of emerging generics and biosimilar omalizumab: Interviewed EU5 payers agree that the use of generic or branded-generic versions of LABA/ICS FDCs, Seretide and Symbicort (AstraZeneca), and biosimilar omalizumab are likely to be promoted. Surveyed pulmonologists indicate that concerns regarding safety and bioequivalency of biosimilar omalizumab to Xolair (Genentech/Novartis) need to be addressed before they would consider prescribing the drug.

 

Comments from Decision Resources Group Analyst Eun-Jin Yang, Ph.D.:

  • "In these times of austerity, payers across the EU5 emphasize that for an emerging therapy to secure favorable terms in reimbursement and pricing negotiations, the drug has to demonstrate superiority in efficacy in head-to-head trials against an appropriate comparator. Thus, given the non-inferiority efficacy profile in asthma indication, Relvar's pricing will be key for its favorable placement in the treatment guideline and for driving uptake."
  • "Even though payers across the EU5 have only a modest cost-saving expectation for generic LABA/ICS FDCs and for biosimilar omalizumab, they indicate a strong interest in promoting the usage of these agents, particularly for treatment-naive patients. However, they are less enthusiastic for biosimilar omalizumab, likely due to the lack of experience with biosimilars to date which contributes to payer and physician uncertainty regarding biosimilar omalizumab's safety and bioequivalency to Xolair. This could be mitigated by biosimilar omalizumab demonstrating a robust safety and bioequivalency profile compared to Xolair."

 

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