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?
Key markets covered:
Key companies mentioned:
- Boehringer Ingelheim
- Coherus Biosciences
- Eli Lilly
- Merck & Co.
- Samsung Bioepis
Key drugs mentioned:
- Epoetin alfa Hexal
- Insulin Lispro Sanofi
- Biosimilars - Corporate Strategies - Reference Brand Developer Strategies
Author(s): Jimmy Jacob; Marta Delgado
Jimmy Jacob, Ph.D. is a Business Insights Analyst in the Biosimilars team. Prior to joining DRG, Jimmy worked as a Scientist in Medimmune and Horizon Discovery mostly involving CRIPSR/Cas9 therapeutics. He received his master’s degree in Biotechnology from University of Dundee and his Ph.D. from Imperial College London. His Ph.D. work involved identifying novel molecules that regulated oestrogen receptor-alpha in breast cancer.
Marta Delgado, Ph.D. is a Business Insight Analyst in the Biosimilars Research team, responsible for the analysis of the biosimilars market across four main therapeutic areas – oncology, endocrinology, immunology and nephrology. Marta holds a Ph.D. in Molecular Neuroscience from University College of London (UCL) and a B.Sc. in Biomedicine from University Pompeu Fabra (UPF), Barcelona. Prior to joining the Biosimilars Research team, Marta worked as a Research Analyst at SKIM, specialising in advanced quantitative studies assessing the potential market opportunities to support life sciences companies in their business decision making.