Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.
Developing biosimilars can be very expensive and time consuming, costing manufacturers hundreds of millions of dollars in development and research costs.
In May 2018, I filed a citizen petition to the FDA. I asked for a comprehensive review of the biosimilar guidelines to bring more rationality and scientific understanding of the testing required to approve biosimilars.The FDA responded 6 months after the filing on November 1, 2018, stating that it needed more time to review the requests made in the petition, even though a reply is expected within 120-180 days.1 The FDA did take some actions.
To bring FDA’s attention, I filed a follow-on citizen petition on September 1, 2023 to address the following remaining issues:6
Recognizing that there are 2 quality attributes: one related to the product dependent on the expression system relatively invariable and the other to the process that can be tailored to match the reference product within limitations. The product-related attributes are critical, while the process-related attributes are part of release specification, such as the protein content and potency, they should not be made part of the analytical assessment exercise, as expected by the FDA. The release specifications should be based on reference product attributes except for the legacy attributes related to the dosage form, such as protein content, potency, particle size, subvisible particles, sterility, etc. The product-related attributes are expected to be the least variable, and these can be tested using a smaller number of lots. The release specification is then established using the number of lots required depending on the variability of the attributes. For example, more lots will be required to establish post-translational modifications but not for impurities that can be well accepted as legacy attributes if there are no unmatched impurities. Many of these suggestions will reduce the time and cost of developing biosimilars.
Enforcing the inclusion of patent information about biologics and FDA regulatory exclusivity information in the "Purple Book" database was a direct consequence of the Purple Book Continuity Act implemented by the FDA.9 The enhanced database will offer novel prospects for industry professionals to identify (1) prospective partnerships for the licensing of current intellectual property, (2) fresh strategies for the enforcement and safeguarding of intellectual property, and, potentially, (3) avenues for the advancement of new technology.
Removing the ability for companies to engage in the “patent dance” through legislative action. This will require a legislative action that is highly sought after in the US Congress.10 Still, the forces of the originator companies have successfully prevented this from happening.
I am optimistic that major regulatory agencies will harmonize the approval regulations to enable developers to secure global selling rights, making the development cost more affordable. I would welcome those with the same mission to comment on my petition or write to the FDA, particularly biosimilar developers and their associations, such as the Biosimilars Council. My proposals are not drawn from just cost-saving intentions; these are to remove any unnecessary testing of humans to enable compliance with the Helsinki Agreement and to enable broader entry of biosimilars.
References
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
BioRationality: How Developers Can Expand Their Monoclonal Antibody Biosimilar Portfolio
March 24th 2025Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.