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Comments on FDA’s interchangeability guidance Posted 02/06/2017

The US Food and Drug Administration (FDA) finally issued its much anticipated guidance on the interchangeability of biosimilars with their reference biologicals in January 2017 [1]. FDA initially released the document for a 60-day comment period (until 20 March 2017), but subsequently extended the period until 19 May 2017 [2].

In the draft guidance, FDA outlines its requirements for biosimilars makers looking to prove that their versions are interchangeable with the originator biologicals.

The agency received 52 comments on its guidance. Many comments came from big pharma companies, including AbbVie, Amgen, Boehringer Ingelheim, Genentech, Johnson & Johnson, Pfizer, Merck, Sandoz, and more. Other comments came from physician associations, such as the American Society of Clinical Oncology, the American Gastroenterological Association and the American Academy of Dermatology Association. Finally, comments were also received from other organizations, such as the American College of Rheumatology, Academy of Managed Care Pharmacy, the Combination Products Coalition, the Biosimilars Forum, RetireSafe, patients, medical practitioners, expert scientists and academicians.

Many of the comments concentrate on the issues of switching studies and FDA’s requirements for interchangeability.  Other issues raised include naming and labelling, definitions, efficacy endpoints and analysis, immunogenicity, extrapolation, disease experts, post-marketing studies, and exclusivity. A more detailed discussion of the comments submitted to FDA is carried out in the series of four articles that follow. 

Related articles
Physician associations comment on FDA’s interchangeability guidance

Big Pharma comments on FDA’s interchangeability guidance

Editor’s comment
Readers interested to learn more about interchangeability are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Interchangeability of biosimilars in the US and around the world

Demonstrating interchangeability and biosimilarity for US biosimilars

GaBI Journal is indexed in Embase, Scopus, Thomson Reuters’ ESCI, and more

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilar interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 2]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-biosimilar-interchangeability
2. GaBI Online - Generics and Biosimilars Initiative. FDA extends comment period for interchangeability guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 2]. Available from: www.gabionline.net/Guidelines/FDA-extends-comment-period-for-interchangeability-guidance

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Source: regulations.gov

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