Abstract: Biosimilar monoclonal antibodies (mAbs) are making their way onto the drug market. Because these are complex molecules in terms of structure and function, assessing similarity between originator and biosimilar mAb is challenging. This review discusses the hallmarks of similarity testing between originator products and mAb biosimilars in terms of product quality attributes, non-clinical and […]
Author byline as per print journal: Tobias Blank, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD Background: As patents for biological drugs begin to expire, the need for scientific guidance on biosimilar drugs grows increasingly important. The European Medicines Agency provided the first guidelines to cover the approval […]
Author byline as per print journal: Thijs J Giezen, PharmD, PhD; Sabine MJM Straus, MD, PhD Abstract: Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small molecule drugs as well as biologicals, as the full safety profile can only be known after they have been placed on the market. Biologicals have […]
Author byline as per print journal: Timothy Ken Mackey1,2, MAS; Professor Bryan A Liang1,3,4, MD, JD, PhD Abstract: Biologicals represent the future of pharmaceutical treatments and innovation. Yet, emerging and developing markets lack access to these often essential medicines. Biosimilar development represents a potential solution to this problem, by offering lower cost and improved access, but […]
