Featured Editorial
How Should We Really Feel About The FDA’s Biosimilar Interchangeability Guidance?
By Anna Rose Welch, editor, Biosimilar Development

Reading through the two versions of the guidance, I had a few thoughts about some of these changes, which led me to reflect more broadly on their impact on the biosimilar regulatory and development sphere.

The China Biosimilars Market: Rise Of A Potential Powerhouse
By Joseph Pategou

Since the introduction of similar biological medicinal products in the EU in 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the United States. How does the rise of the China biosimilars market fit into this established picture?

5 Intriguing U.S. Biosimilar Policy Questions
By Anna Rose Welch, Editor, Biosimilar Development

Biosimilar Development recently hosted a webinar on U.S. biosimilar policies with Frier Levitt Government Affairs expert, Ron Lanton. Here are several questions that came up during the webinar about the impact proposed or current policies may have in the future.

Industry Insights
The Value Of Digital In Biopharma
Article | By Emmanuel Ligner, GE Healthcare Life Sciences

By working together across the biopharma industry, digital technology can be leveraged and data science can reengineer key elements of the drug manufacturing process to ease commercial scale-up.

How Droplet Digital PCR Has Revolutionized Noninvasive Plasma-Based Detection Of Mutations
Application Note | Bio-Rad Laboratories, Inc.

There is an unmet need for assays that monitor and detect the emergence of resistance mutations to targeted therapies, especially for advanced solid tumors where tissue availability is limiting. MolecularMD was interested in developing a plasma-based assay to detect EGFR T790M mutation in circulating tumor DNA as a method for monitoring the emergence of resistance to first-generation EGFR tyrosine kinase inhibitors.

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