Approval Rate for Therapeutic Monoclonal Antibodies Continues to Grow

Now that we have passed the midpoint of 2019, it seemed like a good time to take a look at how the FDA and industry are doing at getting biotechnology product applications approved, and put this into historical perspective.

Between 1965 and the end of Federal Fiscal Year 2013, the FDA had approved approximately 86 therapeutic biopharmaceutical products (TBPs).  

FDA Proposes a Fix for the DMF Issue for “Deemed to Be a License” NDAs

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 requires that on March 23, 2020, all New Drug Applications (NDAs) for biological products will be “deemed to be a license” under Section 351 of the Public Health Service Act (PHSA).  In December of last year, the FDA published a final guidance as well as a Questions and Answers guidance regarding the complex logistics of this regulatory transition. 

The Treasure Map to Biosimilarity Just Got More Granular

The FDA’s recently published draft guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and other Quality-Related Considerations (here) is a significant improvement over the withdrawn 2012 guidance (i.e., Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product) that it replaced.  The increased level of detail and wider breadth of topics gives a significantly better view of the information that the Agency wishes to see in a BLA for a biosimilar product. 

A Deeper Dive on the Biosimilar Interchangeability Guidance Viewed from Our Biologics Expert

On Friday May 10, the FDA published the much-anticipated final version of the guidance document Considerations in Demonstrating Interchangeability with a Reference Product.  We did a general post here  and, while recognizing the final version is similar (highly similar?) to the previous draft from January 2017, a careful review (as outlined here) found several useful and potentially significant changes in the final guidance.

Changes and Updates to the FDA’s Guidance on Non-Proprietary Naming of Biotech Products

On Thursday, March 7, the FDA published a draft supplementary guidance on non-proprietary naming of biological products <here>, which updates the January 2017 Final Guidance on Nonproprietary Naming of Biological Products <here>.  Both of these guidance documents address the FDA’s requirement for including a four-letter nonsense suffix in the proper name for biological products. 

Cropped shot of a man and woman completing paperwork together at a desk

Me KASA es Su KASA – Long Overdue but Very Welcome

On Thursday (September 20th), the FDA held a meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss the Agency’s plans for implementation of the Knowledge‑aided Assessment and Structured Application program (KASA).  The FDA presented to the Advisory Committee two primary goals of the KASA program.  On the one hand, it is intended to make the review of the CMC section of NDAs,