ISR believes we are in the beginning stages of high-growth for Biosimilars. Teva’s August, 2012 FDA approval for two of Amgen’s products (Neupogen & Neulasta) signals a milestone for the development of Biosimilars. It is interesting to note that Teva chose to use the Biologics License Application (BLA) process, normally reserved for novel products, as their route to approval. While this has both regulatory and commercial implications, the clinical development implications center on the fact that if others follow this route, the magnitude of the trials needed for a Biosimilar approval increase dramatically. With increased clinical trial activity through Phase III, the ability to recruit patients into these important studies will become a key stepping stone to Biosimilar commercial success.
- Better understanding of how sites view Biosimilar trials today
- Understand the current barriers to Biosimilar patient recruiting
- Learn what the most successful techniques are for recruiting patients into Biosimilar studies
- Craft patient-centric messaging that will resonate, provide a launching pad for discussions, and drive trial participation
- Conceptualize how an integrated approach is needed between early pharma trial design, sponsor/ CRO assistance for sites in patient recruiting, and developing tools/ collateral/ language/ messages for site and patient recruitment
- Summary and Recommendations, including how pharma/CROs can motivate sites and how sites can motivate patients
- Biosimilar environment at the site
- Barriers to Biosimilar patient recruitment
- Recommendations for Biosimilar patient recruitment
- Study data, including patient recruitment trends, biosimilar recruiting, analysis by practice type, and respondent/ site demographics
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