Newsletter | May 2, 2019

05.02.19 -- USPTO Revisions: Helpful Or Harmful For Biosimilars?

Featured Editorial
Translating Patient And Physician Needs Into Biosimilar Education
By Anna Rose Welch, editor, Biosimilar Development

As we see more real-world evidence (RWE) released in the gastroenterology community, I wanted to learn how one patient advocacy organization is approaching biosimilar education, what challenges the organization is facing, and how the industry and the FDA can better reach patients and physicians.

How Will USPTO Guidance Revisions Impact Biosimilars?
By Doug Robinson, Elisabeth Koral, and Leanne Rakers, Harness Dickey

Since 2012, patent stakeholders in the U.S. have faced remarkable uncertainty in the evaluation of patent subject matter eligibility under 35 U.S.C. 101, particularly in the application of the Supreme Court’s Alice/Mayo test by the USPTO. Will a new revision of the guidance help or harm biosimilars, and how will it change the overall biologics patent landscape? 

Industry Insights
Industry 4.0 Connects Machines And Data
Article | By Dr. Dirk Voelkel, GE Healthcare Life Sciences

By applying remote monitoring, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers process reliability and product quality through connecting machines and data.

The Importance Of In Vitro Assays For The Development Of Biosimilars
Podcast | By Amanda Turner, Bio-Rad Laboratories, Inc.

One biosimilar expert provides an overview of the current state of biosimilars, covering questions such as what type of assays are being employed to test biosimilarity, and what factors are important when considering what assays and antibodies to utilize?

  10th Annual Summit On Biosimilars

June 24 and 25, 2019 | New York, NY

Network with and discuss the future of biosimilars with leaders from both innovator and biosimilar companies at the industry’s leading event directed to the legal, regulatory, and commercial aspects of the biosimilars marketplace. Be in the room as solutions are formulated to the complex regulatory and patent challenges ahead. Use our exclusive discount code for 10% off: P10-999-BIO19.

Connect With Biosimilar Development: