11.07.19 -- Will Biosimilar Automatic Substitution Hit The EU5?
The BioProcessing Asia Conference was created to advance the contribution of bioprocessing sciences, products, and medical interventions to the region. This e-book provides an illustration of cutting-edge presentations: from the sustainability of biosimilars, to the regulatory climate in Asia, the challenges facing the international bioprocessing community, and the latest technologies for viral vector/vaccine production. Some of the articles you’ll find within the e-book are:
By Anna Rose Welch, editor, Biosimilar Development
Though analytical comparability has been embraced by regulators for routine manufacturing changes since 1996, there remain what regulators consider to be analytical limitations giving them pause in determining biosimilarity strictly based on analytics and pharmacokinetics (PK).
By Marta Delgado, Ph.D., Decision Resources Group (DRG)
At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.
This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts.