Fixed dose combination (FDC) products, which have been around for many years, can have both clinical and commercial advantages. Successful FDC products require thoughtful planning, beginning early in the product development and lifecycle management processes.
According to research from benchmarking firm, Best Practices, LLC, there is more to success than just developing a new FDC and launching it. A third of FDC leaders who participated in the research study said the most important lesson learned from their work with FDC products is the need to focus on the differentiated benefit and value that the product can bring to patients, physicians and payers.
The related report, "Fixed Dose Combination Products: Successful Strategies for Developing and Bringing FDC Products to Market," explores the logic, decisions, and strategies involved in developing and commercializing fixed dose combination products.
Some of the key issues addressed in this research include:
- Chief reason for pursuing FDC development
- Measures used to evaluate success
- Years from decision to develop through launch
- Cost of FDC product development Approximate
- Difficulty areas for bringing FDC products to market
- Reasons for partnering with another company to develop FDC products
- Time lapsed from initial contact to signed contractual agreement with partner
- U.S. filing routes used
- EU filing routes used
- Months from filing to approval
- Pre-launch marketing challenges
- Strategies, tactics, practices to help accelerate or impede launch progress
- Lessons learned from executives
- Metrics for effectively communicating business value
The study engaged fifty-one representatives from 34 biopharmaceutical companies. The 55-page report contains more than 150 benchmark metrics, providing executives with the tools, tactics and techniques to help them to successfully develop and commercialize fixed dose combination products.
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