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Market Research Report

Biosimilar Commercial Strategies and Tactics

Published by Datamonitor Healthcare Product code 911301
Published Content info 67 Pages
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Biosimilar Commercial Strategies and Tactics
Published: May 14, 2019 Content info: 67 Pages
Description

The challenges faced by biosimilar developers are not unlike those confronting their branded counterparts. First, companies must develop high-quality biosimilars and obtain regulatory approval. Next, they must then navigate the vast array of commercial nuances that exist at the national level in order for their products to be used in the clinical setting.

Table of Contents

TABLE OF CONTENTS

OVERVIEW

  • In order to realize the biosimilar opportunity, companies must understand the barriers to commercial success and leverage expertise from multiple stakeholder groups
  • When firms begin to define a biosimilar commercial strategy varies from company to company, but across all companies it requires cross-functional collaboration
  • Companies must balance commercial and developmental tactics within a biosimilar's overarching commercial strategy
  • Case studies focused on the commercialization of biosimilars in Europe and the US point to a wide range of successful tactics, while national payers have led the way with forward-looking procurement tactics
  • Sustainability has now become the industry's buzzword, with governments, payers, regulators, and biosimilars companies all working in unison to secure a long-term future for the industry

UNDERSTANDING THE BIOSIMILAR OPPORTUNITY

  • The cost of biological therapies and the "patient access" challenge
  • Biosimilars offer part of the solution to this challenge
  • Regulations have been put in place to help exploit the biosimilar opportunity
  • Current status of European and US biosimilar approvals
  • Commercial performance of biosimilars in Europe and the US has been hugely variable
  • Bibliography

REALIZING THE BIOSIMILAR OPPORTUNITY

  • Balancing regulatory approval and in-market adoption for biosimilars
  • Understanding barriers to the successful commercialization of a biosimilar
  • Bibliography

DEFINING A BIOSIMILAR COMMERCIAL STRATEGY

  • The timing of biosimilar commercial strategy formulation varies from company to company
  • Early strategy development needs to focus on internal and external stakeholder education
  • Defining the strategic vision for a biosimilar is a multi-team, cross-functional effort that requires global and local involvement
  • Bibliography

BIOSIMILAR TACTICS REVIEW

  • Balancing developmental and commercial tactics within a biosimilar's overall strategy
  • Developmental tactics
  • Commercial tactics
  • Bibliography

CASE STUDIES

  • Key case study insights
  • Adalimumab biosimilars in Europe - a new, sustainable model for the procurement of biosimilars
  • Infliximab biosimilars in Europe - Celltrion's extensive partner network gives way to its own commercial infrastructure
  • Pegfilgrastim biosimilars in the US - Coherus seeks commercial differentiation for Udenyca with a "brand-like" strategy
  • Rituximab biosimilars in the UK - commercial strategies focus on education and supporting introduction into clinical practice
  • Bibliography

CHALLENGES, OPPORTUNITIES, AND FUTURE DIRECTIONS

  • The long-term sustainability of the biosimilars market remains the biggest concern, so commercial models will need to adapt
  • Companies must focus on a number of critical success factors in order to drive long-term commercial success in the biosimilars market
  • Bibliography

APPENDIX

  • About the author
  • Scope
  • Methodology

LIST OF TABLES

  • Table 1: Biosimilars approved in Europe during 2018 and early 2019
  • Table 2: Biosimilars approved in the US during 2018 and early 2019
  • Table 3: Key biosimilar market access barriers
  • Table 4: Key commercial and developmental tactics used in the biosimilars market
  • Table 5: Key insights from biosimilar commercialization case studies
  • Table 6: Approved adalimumab biosimilars in Europe (as of 30 April 2019)
  • Table 7: Approved infliximab biosimilars in Europe (as of 30 April 2019)
  • Table 8: Approved pegfilgrastim biosimilars in the US (as of 30 April 2019)
  • Table 9: Approved rituximab biosimilars in Europe (as of 30 April 2019)
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