Key Themes Emerging from The FDA Biosimilar Public Hearing

04 Oct 18

Key Themes Emerging from The FDA Biosimilar Public Hearing


With 27 speakers and 78 follow-up electronic submissions, the Food and Drug Administration’s (FDA) recent public hearing titled Facilitating Competition and Innovation in the Biological Products Marketplace sparked considerable debate. In this edition of the NeuClone Biosimilar Brief we look at the public hearing and some of the key themes emerging from the subsequent electronic submissions.

The Public Hearing

On September 4th, the FDA held a public hearing in White Oak, MD that sought stakeholder input on how the FDA can further the availability of biosimilars and interchangeable products in the US. 27 speakers from a variety of organisations presented on the day including biosimilar and originator companies, patient advocacy groups and more.

The hearing was announced as part of the July Biosimilars Action Plan and requested information from the public on what additional changes can be made to enhance the FDA biosimilar program.

The Agency specifically requested feedback on how to achieve various goals including more efficient biosimilar development and regulatory pathways, developing information resources, increasing understanding of biosimilar and interchangeable products, and addressing gaming tactics stifling biologic competition.

Electronic Submissions

In addition to the public hearing in White Oak, the FDA opened a docket requesting further comments from interested stakeholders via electronic or written submissions until the 21st of September. 78 electronic submissions were made to the docket, including submissions from those who presented in White Oak as well as other industry stakeholders and members of the public.

A range of issues and suggestions were put forward in the 78 submissions. Key themes emerging include:

Key Theme 1: Waiving bridging studies

Multiple submissions advocated that current requirements for bridging studies between a biosimilar and reference product sourced from multiple jurisdictions are too onerous. It was suggested that the implementation of a global reference product would permit sponsors to waive costly clinical bridging studies in certain circumstances (International Generic and Biosimilar Medicines Association, Mylan & BioApprovals).

Key Theme 2: Improving the Purple Book

Calls to improve the functionality and depth of information contained in the Purple Book was echoed by several submissions from Boehringer Ingelheim, Pfizer, the Leukemia & Lymphoma Society (LLS) and more. Suggestions included merging the CDER and CBER product lists, creating an interactive online database similar to the FDA’s Orange Book and even incorporating reference product patent information.

Key Theme 3: Interchangeability requirements

While the FDA published draft guidance on interchangeability in January 2017, none of the 12 currently FDA approved biosimilars have been granted this designation. Some submissions took the opportunity to urge the FDA to promptly finalise guidance on interchangeability (Apotex and Boehringer Ingelheim). Others advocated that in certain instances, the requirement for extensive clinical demonstrations set out in the draft interchangeability guidance are too demanding and result in costly, potentially unethical, multi-switch trials in patients (Biocon, Mylan and the Association for Accessible Medicines (AAM)).

Key Theme 4: Awareness and education

Many submissions were appreciative of FDA’s educational campaigns to date but urged that more needed to be done to improve stakeholder awareness and confidence in biosimilars. Novartis suggested that more campaigns directed at payors and health plans are crucial, while AAM and Pfizer noted that real world evidence gathered in Europe over the last 12 years should be advocated more in the US.

Key Theme 5: Originator company misinformation

Suggestions regarding biosimilar education were sometimes coupled with suggestions to reduce activities seen by some as anti-competitive and misinformation. The AAM noted that misinformation from originator companies has sown doubt among patients and prescribers, ultimately jeopardising the health of patients that stand to benefit from biosimilar adoption. Kaiser Permanente cited how brochures disseminated by the manufacturer of Remicade® cautioned against switching to the biosimilar Inflectra® because it was not designated as interchangeable.

Key Theme 6: Naming

Some stakeholders (LLS, Mylan and National Association of Chain Drug Stores) requested FDA eliminate the four-letter suffixes from all biosimilar and interchangeable non-proprietary names to align with European standards. Momenta advocated only interchangeable and originator products share identical non-proprietary names. Finally, the American Academy of Dermatology and AbbVie supported unique non-proprietary naming designations for all biologics.

Other points

Other interesting suggestions included a recommendation by Novartis on biosimilar critical quality attributes to be within three standard deviations of the mean of the reference product. BioApprovals concluded that extensive analytical and PK biosimilar studies provide reliable predictors of clinical equivalence to the extent that in many cases, efficacy studies are not scientifically valid as the outcome is not in doubt (this has been the subject of a previous NeuClone Biosimilar Brief). Yaniv Heled et al. suggested the sharing of originator company BLA submissions is at the very least constitutionally permissible and would not detract from existing biologic innovation incentives.  Finally, Momenta argued that biosimilar applicants should have the right to challenge originator patents at the time of a Type 3 meeting request, rather than at the currently allowed time of application filing.


The public hearing and opening of the docket were initiated as part of the Biosimilar Action Plan to help inform the FDA on additional policy steps to enhance biologic competition by facilitating greater availability of biosimilar and interchangeable products in the US. The exact timing and extent of change to US biosimilar guidance is unclear, however change seems inevitable.

We encourage readers to explore the docket submissions themselves and explore the perspectives expressed across the full spectrum of biopharmaceutical stakeholders.