The development and commercialization of biosimilars require significant investment in capital, resources, and time. Biosimilar developers must ensure that they are equipped with the necessary expertise in development and manufacturing capabilities. With the number of approved biosimilars constantly increasing, the biopharmaceutical space is set to become more competitive for both innovator and biosimilar companies. As such, it is paramount that biosimilar and innovator companies have well-defined strategies to maximize their competitiveness. In this content, we assess strategies—based on actual practices—that companies can use to flourish in competitive global markets.
The product profiles of the biosimilars that have launched in or will soon enter the major markets (United States, EU5, and Japan) are included in the section “Biosimilar Profiles.” These profiles include information about the biosimilar’s developer(s) and marketer(s), regulatory timelines, development history, approved indications, summary of clinical development, and position in the market.
Questions answered in this report:
How have biosimilar developers achieved success in the biosimilars market?
What options are available to biosimilar developers that lack in-house manufacturing capabilities?
What factors should biosimilar developers consider when designing biosimilar clinical programs?
How can biosimilar and reference-brand companies exploit the multifactorial decision-making process used by stakeholders to differentiate their product from the competition?
What types of data do physicians require to increase their use of biosimilars in biologic-treated patients?
What options are available to reference-brand companies seeking to defend against biosimilar entry?
Yashu Malhotra, M.Sc., is an associate analyst on the Biosimilars and Oncology teams at Clarivate. Previously, she was a senior analyst in the life sciences at Course5 Intelligence. She also worked in competitive intelligence at WNS Global Services. Ms. Malhotra earned her master’s degree in pharmacy (quality assurance) from India’s Delhi Institute of Pharmaceutical Sciences and Research.
