Case Study: Three Ways to Maximize Post Marketing Research for Biosimilars


Case Study: Three Ways to Maximize Post Marketing Research for Biosimilars

Proving therapeutic equivalence is an important step in the approval process for a biosimilar. The research needed is time, labor and resource intensive, making it critical to maximize the investment. UBC’s Clinical Development team is supporting a sponsor with a Phase IV study of a gastroenterology biosimilar. This late phase study has yielded three important lessons for biosimilar manufacturers.

1. Get buy in from key opinion leaders
When a biosimilar is approved through an abbreviated submission process, sometimes there is limited clinical data available. This can form a barrier for uptake and understanding for the physician community. For this product, UBC drove in collaboration with the client the creation of a National Leader group to review the study protocol and lend their expert opinion on the design. This buy in from key opinion leaders helps meet the scientific need the physician community is seeking by shaping the study and objectives to the interests and needs of the community.

2. Engage the commercial team
A Phase IV study can only be undertaken when a product is firmly established on the market. In this instance, the National Leader group opened the door, but it was also important to engage the commercial team to find sites prescribing the product and assist with successful site enrolment. Standard feasibility would not work in this situation and UBC worked to enroll sites that began to prescribe the biosimilar after meeting with the sponsor’s commercial team. Nearly 100% of the sites selected for the study were identified through this collaborative process

3. Collect the right data without overburdening sites
Post marketing studies must strike a balance between the data needed and the effort required from participants. This particular biosimilar study includes drug safety, patient reported outcomes and health resource utilization (HRU) requirements. UBC’s Clinical Operations team drafted the HRU questionnaires to ensure the right data is collected without overburdening the patient or the site staff. All data collection was reviewed by the key opinion leaders to ensure it reflected standard of care.

Partnering with a company that specializes in late phase research allows you to leverage best practices learned through years of designing and implementing post marketing studies. Contact us to discuss how our experts can support your biosimilar study.