Best Practices for Developing and Commercializing Fixed Dose Combination (FDC) Products

The economic advisability of developing fixed dose combination products can be difficult to determine owing to the many associated development and commercial challenges. Key development decisions encompass whether or not to use partners, beginning planning and development early on, and designing and executing trials. Some commercial challenges include proving that the differentiated product has a therapeutic benefit, understanding the market for the combination product, preparing the sales force, and pricing the new combination product appropriately. This benchmarking study explores the logic, decisions, and strategies involved in developing and commercializing fixed dose combination (FDC) products.

From vice presidents to analysts, forward-thinking leaders in research, development, strategy, clinical and market research can use this primary research to identify successful strategies and innovative practices for developing and bringing FDC products to market and to understand the pitfalls and obstacles to avoid in this work.

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Biotech; Consulting; Biopharmaceutical


Companies Profiled:
Abbott; Xanodyne Pharmaceuticals; Victory; Valeant; Solvay Pharmaceuticals; Shire; Sanofi-aventis; Sandoz; PLIVA Pharmaceuticals; Pfizer; Patheon; Noven Therapeuticals; Novartis; Merck; GlaxoSmithKline; Genzyme; IMS; Forest Laboratories; Inc; Elixir Pharmaceuticals; Eisai; Daiichi Sankyo; Catalent Pharma Solutions; Boehringer Ingelheim; Bristol-Myers Squibb.

Study Snapshot

Fifty-one representatives from 34 biopharmaceutical companies participated in this primary research, which was conducted through an online survey instrument and in-depth interviews. Respondents have an average of nearly 10 years of experience in working with FDCs.

Key topics include:

• Development Strategy and Decision-Making
• Alliances/ Partners
• Clinical Strategy/ Registration Pathway
• Project Implementation
• Commercial Strategy (Pre-Launch)
• Innovative Practices and Insights

Key Findings

Successful FDC products require thoughtful planning, beginning early in the product development and lifecycle management processes. Developmental delays, uneven internal support, and common external hurdles slow the process appreciably.

• Less than a third of respondents said they partnered with another pharmaceutical company to develop the FDC. Most successful FDCs are developed by a single company, using its own assets and resources. When companies did partner to develop an FDC product, half the time it was to gain access to one or more of the molecules or to technology.

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.