I have had the pleasure of attending the first ever Biosimilar Drug Development World Europe this week in west London. There has been lots of great conversations about the opportunities that biosimilars present to health care systems across the globe as well as the many hurdles that the industry needs to find solutions too before the potential of these complex drugs can be truly appreciated.
Discussion this morning focussed on pharmacovigilance and immunogenicity for biosimilars. A panel discussion focussed on pharmacovigilance and safety for biosimilars in the clinical stage had a wealth of questions from the audience showing what an interesting topic this is. Panel contributors from Celerion, MHRA, Wockhardt and Merck discussed using non clinical and clinical data to plan pharmacovigilance for biosimilars, RMP for biosimilars and the opportunities in exploring known risks from the originator to develop improved risk management strategies.
The immunogenicity considerations for biosimilars presentation from an expert at the National Institute for Biological Standards and Control gave a great insight into the specific challenges in immunogenicity for biosimilars including the strengths and weaknesses of different analytical techniques and considerations in assay design and validation for immunogenicity assessment. Quality and controls in the manufacturing process were highlighted as key in maintaining stability in the product and maintaingin similarity in the immunogenicity profile between the originator and the biosimilar.