BioRationality: FDA Needs More Time Before Working With USP on Biosimilars Development

My citizen petitioned the FDA to remove the ban on the US Pharmacopoeia (USP) to create monographs for biosimilars, fearing that the monographs may create intellectual property issues based on the historical understanding of monographs.

To overcome this, I published a long paper and replaced monographs with product release specifications that would remove a significant burden in developing biosimilars. The FDA has responded, asking for more time. I have returned my answer, asking why the timing would be an issue.

I believe this is straightforward: let the USP create release specifications and supply validated test methods. This could remove the need to secure multiple batches of the reference product and cut down the time and cost of development by 90%, essentially bringing biosimilars into the category of biogenerics.

I have the full concurrence of the US Pharmacopeia leadership to my proposal, and we are even going ahead with this plan with or without the FDA concurrence and then challenging the FDA as to why this approach should not be acceptable. My petition has no support from big pharmaceutical companies for 2 reasons. First, they are now in the biosimilar field and own the reference product. It is time for science to prevail. It is time for those needing biosimilars to rise and help me get this change quickly.

Once the FDA agrees with my proposal, hopefully, we won’t need to discuss the affordability of biosimilars, and we will no longer be complaining about why only a few of the over 100 biologic drugs that are off patent have biosimilars. I believe that this change will revolutionize the accessibility to biologic drugs worldwide.