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Research & Reports

Searching in Biopharma (1575)

Biosimilars Advisory Service: Global Pipelines, Regulatory Pathways, and Key Stakeholder Perspectives of Biosimilars

The biosimilars market is not all about the United States,
Europe, and Japan. Although these developed markets account for 80% of branded
biologics sales, the remaining 20% is from rapidly growing rapidly markets that
are most in need of more affordable healthcare. Regulators in more than 20 of
the growth markets have adopted biosimilars guidelines and are eager to
establish their own biosimilars industries. This situation has led to a wide
range of companies embarking on biosimilars development within their domestic
markets and overseas. Understanding who the key competitors are in each region
is critical to biosimilar and branded biologics companies.

Questions Answered in This Report:

  • The global biosimilars regulatory environment is rapidly evolving. Which markets have already adopted biosimilars guidelines? How do these guidelines compare to EMA guidelines? Is there likely to be a global process for the development of biosimilars? What do physicians and payers in the United States and Europe think of the regulatory guidance?

  • Approximately 20 companies are developing biosimilar versions of both Rituxan and Herceptin, which are both expected to begin losing exclusivity in the next two years. Which companies are targeting these brands and where are they conducting their clinical trials? What are the other key targets for biosimilars developers and what is the status of their development?

  • The introduction of biosimilars guidance and government initiatives to boost biotechnology in the growth markets are just two of the drivers that have led to many regional companies embarking on development of biosimilars. How do physicians and payers in the United States and Europe perceive biosimilars that have been developed outside their domestic markets?

  • The size of the global biosimilars market is often inflated owing to misclassification of non-innovator biologics (those that were not required to demonstrate comparable safety and efficacy to a reference brand in robust clinical trials) as biosimilars. What is the status of the biosimilars market in the BRIC countries and South Korea? Which companies have the deepest pipeline of biosimilars in Brazil, India, and South Korea?


Markets covered: Global R&D pipeline of biosimilars and in-depth analysis of biosimilars competitive landscape in Europe, United States, India, South Korea, and Brazil.

Primary research: Surveys with 549 specialist physicians across six different specialties in the United States and Europe. Surveys with an additional 60 U.S. managed care organization directors and 10 telephone interviews with key European payer advisors. Primary market research with key stakeholders to assess the following:

- Current opinions on biosimilars developed in emerging markets.

- How country of origin will affect biosimilar uptake.

- Perceptions of regulatory guidance.

Global Biosimilars Development Pipeline Deliverable: Includes more than 200 biosimilars development candidates targeting 32 different reference brands across 13 drug classes.