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Activity Number: 475 - Advancing Innovative RWE Analytics in Drug Development
Type: Topic Contributed
Date/Time: Wednesday, August 10, 2022 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #322331
Title: Analysis of Biosimilar Regulatory Review and Approval Texts from the FDA and the EMA
Author(s): Akash Jayesh Gosai* and Joseph Cook
Companies: Viatris and Viatris
Keywords: Biosimilar; Regulatory; Text Analysis; Prescriber

Some physicians and patients still have concerns with prescribing biosimilars and need additional support from regulators. Common concerns are the evidence of safety and efficacy. We use text analysis to assess and compare biosimilar prescribing information regarding regulatory review and approval from the US FDA and EMA. While the texts are, unsurprisingly, similar based on a lexical analysis of the words used (cosine similarity, 0.73 out of [0,1]); however, the words are used with different frequencies (Kolmogorov-Smirnov, p = 2.2e-16 < 0.01). In particular, safety and efficacy were more commonly discussed in the EMA materials. The EMA material also scored better on the Automated Readability Index (FDA: 23.5; EMA: 20.2), scoring three grade levels lower and indicating an easier to understand presentation. Finally, sentiment analysis was preformed examining statements for overall positive or negative tones, with estimated sentiments for both being positive overall. Addressing key areas of concern more directly and doing so in a more accessible manner, may help to increase prescriber understanding and ability to address patient concerns.

Authors who are presenting talks have a * after their name.

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