Several milestones were achieved last year, mainly the US FDA’s approval of the first biosimilar, Zarxio, which was formally launched in September. Since then, many companies have been seeking approval for biosimilar drugs.
More recently, Sandoz sought regulatory approval for its biosimilar Neulasta, while Amgen also filed for FDA approval of a version of Abbvie’s Humira, one of a number of applications for a biosimilar product in the form of a monoclonal antibody.
This is significant because “it suggests the FDA believes that they can review and accept biosimilarity for a more complicated molecule,” said Stacie Ropka, an IP attorney from Axinn Veltrop & Harkrider with expertise in biosimilars.
Yet, companies still face challenges, mainly, “coming up with the type of assays that FDA feels support a finding of biosimilarity,” Ropka told Biopharma-Reporter. However, the FDA appears to be very willing to work with applicants to make sure they are doing the right type of analyses they think are appropriate.
“The challenge is knowing to speak to the FDA and having enough information for FDA to help you go from one step to the next,” adds Ropka.
Navigating the process
In order to help companies navigate the regulatory approval process for biosimilars, the FDA finalized several guidance documents in April.
The documents provide further clarification on the Biologics Price Competition and Innovation Act (BPCIA), as well as guidance on quality considerations and recommendations for demonstrating biosimilarity using scientific data. Additional clarification in interpreting the BPCIA will come from the courts.
When asked what advice she would give to companies navigating the regulatory approval process, Ropka told us: “Speak with FDA and keep them in the loop as you go forward from one step of demonstrating biosimilarity to the next … FDA has been very good about guiding you and making sure that you are doing the right things, as opposed to just doing everything by yourself.”
Now, as the FDA is beginning to see more biosimilars applications, they are developing a clearer understanding about what they want to see in order to demonstrate biosimilarity. Ropka says that there is a possibility the FDA may require looking at immunogenicity; however, with the FDA it’s all on a case-by-case basis.
“Right now they don’t have a lot of data in front of them to start forming additional conclusions and that’s why they still say it’s a case by case basis,” explained Ropka, “and that’s why it’s important to meet with them.”