Acceptance of biosimilars in the US has been slow, due to high costs (nearly US$250 million) and long development times (around eight years on average). Entrance to the US market has been further hampered by public misunderstanding of the safety of biosimilars, as well as complex licensing laws introduced by FDA. 

The Biologics Price Competition and Innovation (BPCI) Act, a part of the Affordable Healthcare Act, was introduced in 2009 to allow the introduction of biosimilars to the US market. However, several of the statutory requirements within the act are left to the discretion of FDA and lead to restrictions for biosimilars manufacturers.

To encourage the faster development and adoption of biosimilar products in the US, the author makes the following major recommendations to FDA:

• Waiver bridging studies (currently required where there is a non-US product as a reference product)
• Encourage substitution for naïve patients
• Allow in vivo immunogenicity study waivers
• Make pharmacokinetic profiling clinically relevant
• Modify tier testing criteria for analytical similarity
• Clarify analytical testing validation
• Encourage development of novel testing methods
• Accept smaller batch sizes
• Minimize clinical studies

The author also suggests terms such as ‘clinically meaningful difference’ and ‘residual uncertainty’ should be better accounted for in the FDA guidance. These recommendations are also the subject of a recent citizen petition filed to FDA.

FDA itself has acknowledged the need for changes to its guidance, demonstrated by Commissioner Scott Gottlieb’s recent expression of willingness to reinterpret the FDA guidelines for the increased approval of biosimilars.

A more detailed discussion of the recommendations is presented in the following paper [1].

Conflict of interest
The authors of the research paper [1] declared no conflict of interest.

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

Potential changes to the FDA approach to biosimilars have a global impact

Physician associations comment on FDA’s interchangeability guidance

US FDA proposals for naming of biologicals and labelling of biosimilars

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

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Reference
1. Niazi SK. Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(2):84-91. doi:10.5639/gabij.2018.0702.008

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