Willian I Higuchi Collegiate Professor of Pharmacy, Department of Pharmaceutical Sciences, Biointerfaces Institute, College of Pharmacy, University of Michigan, USA

Challenges in Analytical Characterization of Complex Generics and Biosimilars

US FDA has awarded a U18 grant to start a Center for Research in Complex Generics (CRCG, https://www.complexgenerics.org/) at University of Michigan and University of Maryland. For the past three years CRCG has interviewed major stakeholders involved in the development and regulatory approvals of complex generic products. These stakeholders included major generic companies, specialty pharma, trade organizations, contract research organizations and active pharmaceutical product manufacturers. Through this interview process it became apparent that the industry faces significant challenges around development and validation of various analytical methodologies for characterization of complex products. These challenges include quantification and control of nitrosamines, characterization of peptide immunogenicity/purity, IVRT/IVPT studies for topical products, drug-device combinations, and numerous issues around characterization of complex injectables (liposomes, long acting injectables, and iron-colloids). Several case studies will be presented to highlight CRCG’s research efforts in characterization of multivesicular liposomes, peptides, and PLGA microspheres. In addition, a case study of use of orthogonal mass-spectrometry based methods for characterization of glycan microheterogeneity in innovator-biosimilar pairs will be presented.

Anna Schwendeman is the Willian I Higuchi Collegiate Professor of Pharmacy and a member of Biointerfaces Institute at the University of Michigan. Her research focus is on optimization high-density lipoprotein (HDL) nanoparticles for treatment of atherosclerosis, sepsis and drug delivery purposes. In 2016, together with Dr. James Moon she co-founded a company EVOQ Therapeutics that used HDL for immunotherapy delivery. This year, EVOQ completed partnership deal with Amgen to develop drugs for autoimmune diseases valued at $240 million. Prior to starting her academic career in 2012, Dr. Schwendeman spent 12 years in pharmaceutical industry at Cerenis Therapeutics, Pfizer, and Esperion Therapeutics. Esperion Therapeutics was acquired by Pfizer in 2004 for $1.3 billion. She was involved in discovery and translation of HDL drugs to Phase II clinical trials. Currently, Dr. Schwendeman is a co-director of the FDA funded Center for Research on Complex Generics.