FDA’s public hearing on biosimilars draft guidances

Biosimilares/General | Posted 25/05/2012 post-comment0 Post your comment

On 11 May 2012, FDA held a public hearing to gain input on their draft guidances relating to the development of biosimilar products and it seems that the guidances were generally well accepted.


FDA issued three draft guidance documents on 10 February 2012 on biosimilar product development to assist industry in developing such products in the US [1]. The purpose of the public hearing was to receive comments on the draft guidances from a wide range of stakeholders and to obtain public input regarding the agency’s priorities for development of future policies regarding biosimilars and whether or not it aligns with stakeholder needs.

The meeting was chaired by Rachel Sherman, MD, MPH, Associate Director for Medical Policy at the Center for Drug Research and Evaluation (CDER), who headed a panel of other agency members. Although time was limited, allowing only eight minutes per speaker, some of the issues broached included:

  • greater flexibility in the definition of proteins
  • tighter standards for identity of biosimilars, i.e. naming and labelling
  • need for more details on moving drugs through agency approvals
  • need for more clinical studies
  • need for education materials on biologicals and biosimilars for patients and healthcare practitioners
  • interchangeability
  • need for traceability and manufacturer accountability
  • need to foster supply chain stability
  • need for adequate protection of trade secrets of innovator

Not surprisingly it was innovator biological companies, such as Amgen, Genentech/Roche and Janssen Pharmaceuticals, that were calling for additional clinical studies and stricter standards for identity of biosimilars. However, representatives from patient advocacy groups, such as Alliance for Patient Access, Alliance for Safe Biologic Medicines, Colon Cancer Alliance, Immune Deficiency Foundation, National Kidney Foundation and National Patient Advocate Foundation, also strongly supported this position, putting safety higher on the agenda than price savings. FDA, however, is sticking to its position that human clinical trials should not be repeated.

Other groups represented at the meeting, e.g. American Pharmacists Association and Pharmaceutical Care Management Association, were mostly concerned about patient safety, especially concerning packaging and labelling of biosimilars.

All of the stakeholders voiced their support for the implementation of an education and communication plan to help the public and others, e.g. pharmacists, understand biosimilars.

Naming and interchangeability were popular subjects at the meeting, for which FDA has stated its intent to publish future guidance on both subjects. Advocates for unique naming for biosimilars claimed that if a common non-proprietary name were used, patients would not know which drug they are getting and it would be difficult to attribute adverse events to a particular product. While advocates for a common name raised the possibility of overdosing or mis-dosing if different names were used, as a patient could inadvertently be prescribed two versions of the same biosimilar. Suggestions were also made for a prefix to be added to the labelling of biosimilars which are approved by FDA as interchangeable.

While all stakeholders commended FDA for its scientific and safety-oriented approach in the draft guidances, both innovator and biosimilars companies also expressed their desire for FDA to harmonise with EMA’s guidances for biosimilars, which provide detailed guidance for biosimilars according to classes [2]. This they agreed would both save FDA resources and speed up approvals for biosimilars.

An archived webcast of the meeting can be viewed at http://www.fda.gov/Drugs/NewsEvents/ucm265628.htm and will be available for one year.

Related article

FDA announces public hearing on biosimilars’ guidelines


1.  GaBI Online - Generics and Biosimilars Initiative. FDA finally issues draft biosimilar guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 May 25]. Available from: www.gabionline.net/Guidelines/FDA-finally-issues-draft-biosimilar-guidance

2.  GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 May 25]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars

Source: FDA

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