AsphaNews – Special Edition FDA

Read about the latest news regarding the FDA

Read about the latest news regarding the FDA
June 26, 2015

On the 27th of May, ASPHALION organized the 2015 Open Seminar:  “FDA – Road to Success”:

The conference was held in Barcelona and on counted with the participation of Bruce Thompson, Asphalion’s dedicated US Agent. The latest news and tendencies of the FDA were presented to a wide audience of professionals from the European pharma sector: pharmaceutical companies, consultancies and researchers.

Asphalion shared its experience with FDA submissions, from setting the strategy, preparation and submission of the application dossier, until the successful market entry and maintenance phase. An overview of all FDA submission types and its specifics was presented. The participants had the opportunity to discuss with our US Agent the particulars of their own projects.

We are thrilled with the success of this event and especially by the positive feedback received from the attendees.
As a result we have already initiated further projects in addition to our already ongoing FDA collaborations. Besides several INDs and NDA projects, we have already booked 5 pre-IND meetings with the FDA within the next months.
Due to the increase in interest in FDA topics, we will repeat the successful Open Seminar FDA in the city of Munich in spring 2016.
If you are interested in attending, please send us a mail to the following address:

What’s new at FDA:

New FDA Commissioner
In April 2015, Dr. Stephen Ostroff, M.D. was appointed as the FDA’s acting commissioner of food and drugs and replaces Margaret A. Hamburg, M.D.
FDA Approved the First Biosimilar, Zarxio (Filgrastim), on 6th March 2015
Zarxio is the first biosimilar approved by the FDA. In Europe, Filgrastim was registered as a biosimilar back in 2008, being currently one of the 19 biosimilars already approved in Europe, by EMA.
Biosimilar Guidelines – Four New Guidelines Issued in April 2015
The four new guidance documents should assist bringing clarity to the field of biosimilar applications to the FDA. The guidelines are:
  1. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; assists companies in demonstrating that a proposed product is indeed biosimilar to an existing biologic product, and is intended to provide clarity to manufacturers about the expectations for a biosimilar development program
  2. Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; focuses on the analytical studies that demonstrate that the product is “highly similar? to an existing biological product
  3. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; answers common questions about the biosimilar development and application process and contains information intended to provide a better understanding of the law that allows biosimilar development
  4. Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (DRAFT); open to receiving comments from the public, this guideline answers a variety of additional questions that have arisen regarding the biosimilar development process.
Breakthrough Therapy
A presentation on the use of the “breakthrough therapy” approval pathway was provided. The purpose is to expedite the development and review of drugs and biologics for serious diseases and conditions.
As of March 2015, the FDA received 293 requests for breakthrough therapy designation. Out of these, only 82 were granted (less than 1 in 3).
On the other hand, submissions for Fast Track applications were much more successful, with a grant rate of 62-75%.

In June 2015, the FDA provided a statement on the use of the new Module 1 specification. From 15th June 2015, the FDA will accept submissions using the new M1 Specifications in eCTD format.

From 15 June 2017, the eCTD will be the mandatory format for NDAs, ANDAs, BLAs, and master files. For INDs this will be 15 June 2018.
For all of these submission types, you must electronically submit any amendments, supplements, and reports, even if the original submission was submitted to the FDA prior to implementation of the electronic submission requirements.
Data-set Requirements for Clinical Studies

From December 2016 it will be mandatory to have data-sets for non-clinical and clinical studies.

For any specific FDA question, please contact

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