Novartis subsidiary Sandoz became the first firm to announce the US Food and Drug Administration (FDA) had agreed to review a biosimilar drug in July, after submitting its version of Amgen’s Neupogen (filgrastim) through the 351(k) pathway.
While biosimilars are available in a number of markets, including Europe and India, the US is still awaiting its first. However, the Meeting of the Oncologic Drugs Advisory Committee (ODAC) tomorrow to discuss whether Sandoz’ EP2006 - marketed outside the US as Zarzio – is highly similar to Amgen’s reference product could be a major breakthrough for biosimilars the US.
The review is likely to be positive for Sandoz according to the FDA’s briefing document which found the analytical properties and efficacy of EP2006 were “highly similar, notwithstanding minor differences in clinically inactive components,” to Amgen’s reference drug.
Furthermore, extensive PK and PD similarity studies support the Sandoz’ contention that there are no clinically meaningful differences in the effectiveness of EP2006 for all five indications for which Neupogen is approved.
Protein problem
The FDA expressed concerns regarding the commercial manufacturing process for EP2006 tested after finding the six commercial batches tested were “lower in protein content than the comparator products and do not meet statistical equivalence.”
However, additional data provided by Sandoz has led the agency to amend its view and determine the commercial drug product actually has the same strength as the reference product.
“[The FDA] clarify that their original assessment around manufacturing was not accurate and that the difference was due to the limited number of lots analysed,” Sandoz spokesman Sreejit Mohan told Biopharma-Reporter.com.
“Based on additional data that we provided, they have now deemed this to be a non-issue.”
US launch date
While tomorrow’s review and vote as to whether EP2006 should receive licensure as a biosimilar product for the five indications for which Neupogen is currently licensed is set to be successful for Sandoz, the launch of a first US biosimilar may still be a while away.
“We can’t comment on launch timelines for competitive reasons,” Mohan said. “What I can say is that FDA has said they are aiming for a ten month review process for 50 percent of their biosimilar applications. We will continue to work with the agency as they review our file.”
When contacted, a spokesperson from the FDA told us the agency was “unable to discuss unapproved products outside the formal advisory committee environment.”
The 351(k) pathway, created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA), permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, unlike the full Biologics License Application (BLA) - 351(a) pathway - which most originator biopharmaceuticals are filed under.