W 31: Impact of Biosimilars in Clinical Practice and Clinical Research: Results of Questionnaire- Based Survey

Poster Presenter

Nithin Sashidharan

Senior Medical Advisor
Pharm-Olam International
India

Objectives

The objective of this study is to analyze the trends observed in biosimilar drug prescriptions amongst treating physicians and their interest towards biosimilar drug development.

Method

For this study we reviewed available literature regarding regulations related to Biosimilar drug dev. & biosimilar prescription around the world. We also conducted a global survey to physicians from various specialties to understand the factors involved in prescribing biosimilars in their practice.

Results

The majority of the physicians were aware of the term “Biosimilars” and had good understanding about the process involved in developing biosimilars. The preliminary results of the study indicate that there is interest being shown in prescribing biosimilars in regions where biosimilars are available. Various factors including patient’s discretion were the primary reason for prescribing biosimilars. Oncology, autoimmune disorders and endocrinology were the major disease segments in which biosimilars are prescribed as per the study. Keen interest was shown in participating as investigators in clinical trials involved with biosimilars. There is strong opinion amongst physicians that Biosimilars must be compared to originator molecules in clinical trials to determine efficacy and safety parameters.

Conclusion

There is steady increase in usage of biosimilars amongst treating physicians across the globe. While there are certain concerns with availability and regulations in certain regions, biosimilars are slowly being preferred for their cost effectiveness in various debilitating disease conditions. With the number of clinical trials related to biosimilars on the rise, more physicians are beginning to understand that biosimilars are unique molecules in comparison to generic drugs. More resources need to be provided by pharmaceutical industry for training the physicians and patients on better understanding of efficacy and safety of biosimilars.