A legal framework for approving biosimilars in the US was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Dr Leah Christl from the US Food and Drug Administration’s (FDA) gave an update on the biosimilar programme in the US at the 16th Biosimilar Medicines Conference in April 2018 [1].
Since the BPCI Act was signed into law on 23 March 2010 by President Barack Obama FDA has issued more than 10 guidelines to assist biosimilar sponsors with their abbreviated applications [2]. The agency approved its first biosimilar Zarxio (filgrastim-sndz) in 2015 [3] and has now (18 May 2018) approved 10 biosimilars [4]:
According to Dr Christl, as of 1 April 2018, 63 programmes were enrolled in the Biosimilar Product Development (BPD) Program. The Center for Drug Evaluation and Research (CDER) has also received meeting requests to discuss the development of biosimilars for 31 different reference products.
In addition, since programme inception and as of 1 April 2018, 12 companies have publicly announced submission of 23 351(k) Biologic License Applications (BLAs) to FDA.
FDA is still in the process of developing guidelines regarding biosimilars and has committed to publish draft, revised draft or final guidance describing the following:
– Statistical approaches to evaluate analytical similarity
(draft guidance published September 2017; revised draft or final guidance by 5/21/19)
– Considerations in demonstrating interchangeability with a reference product
(draft guidance published January 2017; revised draft or final guidance by 5/19/19)
– Labeling for biosimilar biological products
(draft guidance published March 2016; revised draft or final guidance by 5/31/19)
– Formal meetings between the FDA and biosimilar biological product sponsors or applicants
(final guidance published November 2015; revised draft by 9/30/18)
– Good review management practices
(revised draft by 9/30/18)
– Processes and further considerations related to post-approval manufacturing changes for biosimilar biological products
(draft guidance by 3/31/19)
In addition, the agency participates in a FDA-EMA (European Medicines Agency)-Health Canada-PMDA biosimilars cluster. This cluster was originally set up in June 2011 between EMA and FDA [5], with Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) joining later.
In October 2017, FDA launched its Education & Outreach Campaign for Biosimilars, with the aim of increasing understanding, awareness and knowledge about biosimilars. And in May 2018, the agency released a five-part video series to provide an overview of biosimilar and interchangeable products and to highlight key concepts about the development and approval of these products.
Finally, FDA also has a 2018 Strategic Policy Roadmap which outlines the agency’s plan to launch a comprehensive programme to encourage biosimilar competition.
Dr Leah Christl is the Associate Director for Therapeutic Biologics and Director of Therapeutic Biologics and Biosimilars Staff at FDA’s CDER.
Conflict of interest
The author of the presentation [1] did not provide any conflict of interest statement.
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References
1. Christl L. Update: Biosimilar Program in the U.S. 16th Biosimilar Medicines Conference – Biosimilar Medicines: unlocking the full potential of biologics; 26-27 April 2018; London, UK.
2. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 15]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 15]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA report on collaborative efforts [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 15]. Available from: www.gabionline.net/Policies-Legislation/EMA-and-FDA-report-on-collaborative-efforts
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