Newsletter | March 18, 2021

03.18.21 -- Biosimilar Regulatory And Legislative Actions Set Tone For 2021
 
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Featured Editorial
Regulatory And Legislative Actions Set The Tone For Biosimilars In 2021
 
By P. Chen, K. McGlynn, and J. Shmuel, Fish & Richardson P.C.

This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors review FDA’s preparation for the March 23, 2020 transition date, as well as FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic. 
The Little-Known Drivers Behind 2020’s (And 2021’s?) Biosimilar Boom
 
By Anna Rose Welch, Chief Editor, Biosimilar Development

There were a few efforts discussed during the recent DIA Biosimilars Conference that I wanted to single out as being particularly critical to the inner workings of this market. I’d argue these efforts are just as noteworthy —perhaps even more worthy — of celebrating as biosimilars’ resulting market performance. 
Industry Insights
Is Your Biologic At Risk For Protein Aggregation? Part 3
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing

The main culprit of a failing biologic drug is usually a flawed formulation. In this article, we cover formulation components and how they may affect protein aggregation. Part three of a three-part series.
Meeting The Process Development Challenges Of A Diverse Biologic Pipeline
White Paper | By Mats Lundgren, Cytiva

The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Understanding what challenges diverse molecules can create and how to manage these challenges is key to ensuring they reach patients safely and efficiently.  
Success At Speed: Best Practices To Accelerate Vaccine Development
E-Book | By Amélie Boulais and Piergiuseppe Nestola, Sartorius Stedim Biotech

This collection of articles documents each step in the vaccine development journey and how technology and partnerships make the difference in getting medicines to patients when they need them most.
News Headlines
Solutions
BD Intevia 1mL Two-Step Disposable Autoinjector
BD Medical - Pharmaceutical Systems
Product Characterization Assay Package - Cell Line Development
MilliporeSigma (Product Characterization)
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