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Biosimilar Commercial Strategies and Tactics

  • ID: 4846147
  • Report
  • May 2019
  • Region: Global
  • 67 pages
  • Datamonitor Healthcare
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In order to realize the biosimilar opportunity, companies must understand the barriers to commercial success and leverage expertise from multiple stakeholder groups

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.
Fundamentally, the mix of developmental and commercial tactics which companies decide to implement as part of a biosimilar brand’s commercialization strategy needs to be customized to the type of product being developed, its target indication, patient type, and the country in which the product is to be sold.

When firms begin to define a biosimilar commercial strategy varies from company to company, but across all companies it requires cross-functional collaboration

Time is often limited when it comes to planning the commercial strategy for a biosimilar, but nuances continue to exist across company types. For example, highly integrated companies with a heritage in biologics (eg Amgen) tend to get more time compared to smaller, pureplay companies (eg Coherus) and distributors (eg Napp Pharmaceuticals).

A key focus of this early strategy development is education, including internal and external stakeholder groups. Defining the strategic vision for a biosimilar is also a multi-team, cross-functional effort that requires global and local involvement. In many cases the commercial teams will take the lead, but due to the significant need for information and education at the healthcare provider level on biosimilars, medical, clinical, and regulatory teams will also play a critical, strategy-shaping role.

Companies must balance commercial and developmental tactics within a biosimilar’s overarching commercial strategy

Ultimately, the tactics a company selects can be boiled down to ones that either focus on enhancing the brand at its most basic level (ie its clinical profile) or improving the commercial proposition of the brand or brand family. Tactics such as assertive pricing, new dosage forms, generating switching data, and novel formulations have all been tried with varying degrees of success.

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
  • In October 2018, Humira biosimilars were launched in Europe by four different companies (Biogen, Sandoz, Mylan, and Amgen). In preparation for this launch, NHS England took the decision to seek a more sustainable method for procurement – instead of awarding business to the cheapest biosimilar, all four biosimilars gained a share of the market.
  • Celltrion was the first company to gain approval for a complex monoclonal antibody (MAb) biosimilar with Remsima/Inflectra, an infliximab biosimilar. The company’s early commercial strategy focused on extensive partnering and the generation of significant amounts of clinical data, both of which have been wildly successful. Not willing to rest on its laurels, Celltrion is now embarking on a new “go it alone” commercial strategy with its novel, subcutaneous formulation of its infliximab biosimilar at the core.
  • Perhaps influenced by US-specific market needs and its Amgen heritage, due to a number of its senior employees having worked at Amgen in the past, pureplay biosimilars company Coherus has adopted a “brand-like” strategy for its Neulasta biosimilar, Udenyca, in the US. Including over 60 medically and commercially focused team members, US-based manufacturing, deals with several key payers, and extensive reimbursement hub services, Coherus’s focus on giving Udenyca the same “look and feel” as an originator brand appears to be paying off.
  • One could argue that Sandoz’s strategy for its MabThera biosimilar, Rixathon, in the UK was unsuccessful. Despite investing in extensive education and supporting the clinical introduction of MabThera biosimilars via The Cancer Vanguard program, first-to-market Truxima (from Celltrion and Napp Pharmaceuticals) has captured over 80% of the UK market. Another perspective, however, is that Sandoz is playing the long game, and via a significant amount of good faith now banked from its support of biosimilars in the UK, future Sandoz products could get the nod ahead of those from other companies.
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

The future sustainability of the biosimilars market is the biggest concern among key stakeholders, industry observers, and experts interviewed for this report. Health services want robust supplies of biosimilars, not a situation where only one or two manufacturers are left. The challenge is establishing a system that allows this to happen, and as a result commercial models will need to evolve to support this.
Perhaps ironically, it is national payers, regulators, and policymakers, not biosimilars companies themselves, which hold much of the power to influence the longer-term sustainability of the biosimilars market. Via the procurement strategies chosen, and the policies and regulatory pathways put in place, each stakeholder has the opportunity to shape the next wave of biosimilars for future generations.
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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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