Newsletter | November 7, 2019

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:

Download the full e-book here: BioProcessing Asia Conference In Review

Featured Editorial
Regulators Emphasize Patience In Tailored Biosimilar Development
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).

Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook
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.

Intro To Prefilled Syringe Selection: Staked-In Needles
By Michael Song, Ph.D., AstraZeneca

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. 

Industry Insights
4 Steps Toward End-To-End Connected Manufacturing
Article | By Avril Vermunt, GE Healthcare Life Sciences

Breaking down the implementation of continuous manufacturing into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.

Advances In Immunotherapy For Cancer
White Paper | By Leala Thomas, Bio-Rad Laboratories, Inc.

Over the past decade, advances in oncology research have resulted in many new treatment options that include immunotherapies. This article examines these newer therapies in more detail.

Maximize Performance With HyClone Media And Supplements
GE Healthcare Life Sciences
Connect With Biosimilar Development: