In its continuous efforts to facilitate and support the development and market authorization of complex generic drugs FDA has recently finalized the Guidance for Industry “ANDA for Certain Highly Purified Synthetic Peptide Drug Product That Refer to Listed Drugs of rDNA Origin”.
Although this guideline provides clarity with respect to requirements and review process for complex generics of certain nature, scientific and regulatory challenges remain a big hurdle on the way to successful approval of generic drugs falling under this guideline.
Bachem as the leading manufacturer of synthetic peptide APIs and technological front-runner has decades of experience in production, analytical characterization and regulatory submission of complex generic peptides.
Please join our Webinar to get to know about our unique practical experience with compliance with the ANDA Guideline and how we can support your generic drug development with our high quality peptide APIs as well as analytical and regulatory knowhow.
Dr. Sergey Malashikhin is a Group Leader Generics – Business Development at Bachem Switzerland. In this position, together with his team he is responsible for customer projects with complex generic peptide APIs manufactured at Bachem as well as for early and development stage generics projects. Prior to joining Bachem he worked in a commercial role in a Swiss Life Science company and in R&D of a Japanese technology corporation. He earned his PhD in Organic Chemistry at the University of Zurich, Switzerland.
Dr. Martin Ostermaier is Product Manager for Research Chemicals and Specialties at Bachem since September 2019. After his PhD at the ETH in Zürich he was Scientific Officer at the Paul Scherer Institute, where he was author of 10 scientific papers and inventor of 3 patents. At the same time, he was CEO, Co-Founder and Chairman of the Board of Directors at InterAx Biotech, where he transformed a business idea in the field of “Artificial Intelligence for Drug Discovery” into a commercially successful company with international customers.