The global market for biosimilars is expected to grow at an exponential rate in coming years, from only $3 billion in 2016 to a forecasted $10 billion by 2021. So, it is not a surprise that biosimilar development has continued to be a hot topic in our industry in 2017, particularly related to regulation. To secure regulatory approval for a biosimilar, the manufacturer must demonstrate that the biological product is highly similar to its reference biological product, with no clinically meaningful differences in safety, purity, and potency. But, neither FDA nor EMA have yet specified exactly what the bioanalytical testing requirements should be for determining a biosimilar’s comparability to a reference biologic.
In an effort to fill this void, the AAPS Ligand-Binding Assay Bioanalytical Focus Group and the AAPS Biosimilar group created the Biosimilars Action Program Committee (APC). The group has been tasked with identifying the bioanalytical challenges unique to biosimilar development, and to recommend practices to address those challenges. The results of this work were published in a 2014 AAPS Journal paper that you can find here, and earlier this year Dr. Arno Kromminga presented a webinar with AAPS entitled “Bioanalytical Methods in Support of Biosimilar Drug Development” to review in more detail APC’s recommendations on the development and validation of PK, anti-drug antibody (ADA), and neutralization antibody assays (NAb) for biosimilar drug development.
In the webinar, he discusses how these recommendations can be used to reduce the risks present in biosimilar drug development, and also evaluate the implications of the recently released FDA guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product”, for clinical pharmacology studies for proposed biosimilar products.
It is important to understand that FDA uses a totality-of-the-evidence approach to review marketing applications for biosimilars, meaning that they consider data from the manufacturer’s structural, physio-chemical, animal, pharmacokinetic (PK), immunogenic, and clinical studies comparing the biosimilar and reference biologic. During the webinar, he reviews how manufacturers can generate data in a stepwise approach, to address any uncertainty about the biosimilar’s comparability after each step. Dr. Kromminga also discussed these steps in more detail in an interview conducted for AAPS Newsmagazine, which you can read here.
On average, the cost of a generic drug is 80- 85% lower than the brand name product, and with these potential savings biosimilar development shows no sign of slowing down. As an industry, we must remain committed to creating guidance that can be effectively, consistently implemented by all those are working in this innovative and promising field. You can learn more about the AAPS Biosimilar group and its recent work here.