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Biosimilar Development Newsletter | February 09, 2020 | View web version here.
 
Sponsor
  Webinar: 2019 Year In Review
 

ISR is a market research firm operating exclusively in the pharmaceutical manufacturing and clinical research space. In 2019, they conducted approximately two dozen individual pieces of market research for syndication. This webinar will summarize many of the important learnings from these projects, providing attendees with real, usable data for 2020 activities.

Featured Editorial
Sandoz Executives: Have Biosimilars Lived Up To Their Promise?
 
By Anna Rose Welch, editor, Biosimilar Development

In the first part of this two-part article, I picked two Sandoz executives' brains about the progress they’ve observed and how challenges for the industry have evolved over the past 10 years.

6 Important Elements Of The New STRONGER Patents Act
 
By John Serio, Burns & Levinson

Over the past decade, patent reform has been an area of emphasis for Congress. This article explores several of the main tenets of the STRONGER legislation, which biologics and biosimilar makers should be aware of as the Inter Partes Review (IPR) currently remains a critical part of patent litigation today.

Industry Insights
Is Your Biologic At Risk For Protein Aggregation? Part 1
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing

This is the first installment in a three-part series that examines what causes protein aggregation and practical steps you can take to mitigate the risk.

Key Steps To Ensure Optimized And Reproducible qPCR Experiments
Article | Bio-Rad Laboratories, Inc.

Real-time quantitative PCR (qPCR) is a powerful and commonly used method for quantifying gene expression. It is an accessible technology that can be quickly learned. However, by keeping a few key steps in mind as you plan and run your real-time PCR (polymerase chain reaction) experiments you can optimize your qPCR experiments and ensure high-quality data and reproducible results.

Process Effects On Drug Product Quality In Pharmaceutical Manufacturing: A Validated Measurement Process
White Paper | GE Healthcare Life Sciences

This white paper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes and how a systematic approach with validated SPR (surface plasmon resonance) assays can help in this respect.

News Headlines
FDA And FTC Announce New Efforts To Further Deter Anti-Competitive Business Practices, Support Competitive Market For Biological Products To Help Americans
The Competition Council Sanctioned Roche Romania With Fines Of 12,8 Million Euro
Pfizer Brings Three New Biosimilars To U.S. Patients At Substantial Discounts
Key Trends That Will Shape The Immunology Market In The Next Decade, According To GlobalData
Pfizer Receives Positive CHMP Opinion For Oncology Biosimilar, RUXIENCE (rituximab)
Bio-Thera Solutions Announces Positive Top-Line Results For BAT1706, A Proposed Biosimilar To Avastin
Solutions
5 Key Considerations To Future-Proof Your Single-Use Biomanufacturing Capacity
GE Healthcare Life Sciences
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