Biologics Community

In 2005 and 2015, respectively, the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have issued guidance documents for the development of biosimilars. The goal of these guidances was to outline a regulatory mechanism that balanced innovation and competition for biological products analogous to the generic regulatory pathway for drug products, which serves to bring affordable off-patent drugs to patients. Similar to generic pathway, biosimilar development programs are not designed to (re)establish safety and efficacy but to show ‘similarity’ between a biosimilar and a reference product. However, biologic products have much greater complexity with respect to manufacturing, delivery, and immunogenicity as compared to small molecule drugs. In small molecule generic development, comparing exposure and establishing pharmacokinetic (PK) bioequivalence to the branded product is generally considered sufficient evidence for approval. However, given the complexity of biologic products, biosimilar development programs are rooted in a totality of evidence approach including but not limited to preclinical and clinical pharmacokentic/pharmacodynamic (PK/PD), immunogenicity, and clinical safety and efficacy between the proposed biosimilar product and the reference product. Therefore, biosimilar development programs have to follow a fundamentally different development paradigm than both innovator biological products and generic drug products to account for the increased complexity within the similarity assessments. As such, biosimilar development programs are not one-size fits all, which has opened a huge opportunity space to innovate and disrupt historical thinking about drug development, competition, and similarity assessments. The breadth and interdisciplinary nature of clinical pharmacology positions clinical pharmacology as a leader and driver of innovative approaches to address the complexity associated with biosimilar development. In this session, we highlight new innovations in response to biosimilar drug development and how those innovations might disrupt drug development and subsequent health care. We aim to bring awareness to the community on developing biosimilars, as well as provide real world examples and strategies from a clinical, clinical pharmacology, and regulatory perspective.

Learning Objectives

1. For attendees to increase awareness on developing biosimilars.

2. Provide real world examples and strategies from a clinical, clinical pharmacology, and regulatory perspective.

Session Schedule

3:30 PM - 3:36 PM ET
Welcome and Introduction
Aruna Dontabhaktuni, PhD

3:36 PM - 3:50 PM ET
Overcoming the Challenges in Bioanalytical Assays for Biosimilar: Lessons Learned and New Era
Susana Liu, PMP, MSc

3:50 PM - 4:04 PM ET
Pharmacokinetic Similarity Demonstration of Highly Immunogenic Biologics
Chandra Udata, PhD

4:04 PM - 4:19 PM ET
Regulatory Considerations in Biosimilar Drug Development (FDA)
Yow-Ming C. Wang, PhD

4:19 PM - 4:30 PM ET
Live Q&A, Closing Remarks, and Future Plans
All Speakers