Check out this presentation from PAREXEL Consulting experts to learn about key regulatory processes affecting biosimilars development including an an overview of the 351(k) Pathway, FDA approvals and managing post-approval challenges.
1. Scott, B. et al., “Biosimilar Monoclonal Antibodies: A Canadian Regulatory Perspective on the Assessment of Clinically Relevant Differences and Indication Extrapolation.” J Clin Pharmacol. 2015 Mar;55 Suppl 3:S123-32. 2. European Medicines Agency, Draft Guideline on Immunogenicity assessment of 6 biotechnology-derived therapeutic proteins, 24 September 2015, 1 EMEA/CHMP/BMWP/14327/2006 Rev. 1. 3. FDA, Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products (August 2014). 4. PMDA, Guidelines for the Quality, Safety and Efficacy Assurance of Follow-on Biologics,” English Translation (PFSB/ELD No.0304007) by PhRMA. 5. World Health Organization, Guidelines of Evaluation of Similar Biotherapeutic Products (SBPs) (2009).
1. Ireland Health Products Regulatory Agency, Guide to Biosimilars for Healthcare Professionals and Patients, 14 October 2015. 2. MHRA, Drug Safety Update: Biosimilar products (February 2008), https://www.gov.uk/drug-safety-update/biosimilar-products. 3. Paul Ehrlich Institute's position on the interchangeability of biosimilars.