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 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?
Case Studies: Collaborating With Medical Device Companies
Gaining Approval for Orphan Indications
Biologics That Have Secured Orphan Drug Designation to Maintain Revenue in the United States
Leveraging Intellectual Property and Legal Protections
Preparing a Legal Strategy
Legal Defense Strategies Used in the United States
Case Study: AbbVieu2019s U.S. Humira Defense Strategy
U.S. Launch Dates of Adalimumab Biosimilars
AbbVie's U.S. Humira Defense Strategy
Case Study: Sanofiu2019s Use of the Drug Price Competition and Patent Term Restoration Act to Protect Lantus From Biosimilar Competition
Case Study: Amgen's Defense of Enbrel's Intellectual Property in the United States
Pricing as a Defense Strategy
Pricing Strategies for Reference-Product Sponsors
Leveraging Discrepancies Between Biosimilar and Brand Patient Shares Using Rebates
Example: Hypothetical Rebate Negotiations
Case Study: Janssen's Exclusive Tender Win for Infliximab in New Zealand
Dual Pricing Strategies in Emerging Markets
Case Study: Rocheu2019s Dual Pricing Strategies
Authorized Generics
Case Studies: Authorized Generics Launched by Eli Lilly and Novo Nordisk
Case Study: Authorized Version of Nesp in Japan
Subscription Pricing Models
Sanofiu2019s Insulins Valyou Savings Program
Novo Nordisk's My$99Insulin Program
Deal Making With Key Stakeholders
Case Study: Johnson & Johnson Defense of Remicade's Market Share in the United States
Case Studies: Exclusive Agreements Between Amgen and DaVita and Vifor Pharma and Fresenius
Innovative Performance-Based Risk-Sharing Schemes
Counterdetailing and Value-Added Services
Counterdetailing
Value-Added Services
Hamzah Aideed, M.Sc.
Hamzah Aideed, M.Sc., is a manager on the Biosimilars team at Clarivate. His team conducts both primary and secondary market research to provide in-depth analysis and key insights into biosimilars and the biopharmaceutical industry. Previously, Mr. Aideed was a senior research executive in consulting at McCann Health, specializing in the design and execution of advanced qualitative and quantitative research methodologies for bespoke ad-hoc consulting projects. He holds an M.Sc. in biotechnology, bioprocessing, and business management from the University of Warwick and a B.Sc. in biological chemistry from Aston University in Birmingham.