Novo Nordisk has told the FDA allowing alternative delivery devices for biosimilars creates “significant safety implications”.
US Food and Drug Administration (FDA) draft guidance released in February allows biosimilars to use different drug delivery devices than their reference products. Novo Nordisk has concerns about the proposal though.
“A change in delivery device or container closure system may have significant safety implications”, James Shehan, corporate vice president at Novo Nordisk, wrote in feedback to the US regulator. To cut safety risks Shehan wants the FDA should take “a more cautious approach” to product changes.
Shehan cites the example of Eprex (epoetin alfa), an anaemia treatment sold by Janssen-Cilag, which was linked to an increase in cases of pure red cell aplasia after a formulation change in 1998. Studies found the most likely cause was leachables from uncoated rubber stoppers in prefilled syringes.
To prevent a biosimilar with an alternative delivery device or closure system having a similar effect Shehan advises the FDA to make sure any change “is supported by a robust data package”. The draft guidance recommends use of leachable and stability studies but Shehan wants stronger wording.
“The guidance should state that the biosimilar applicant will always need to conduct compatibility testing – including extractable/leachable studies and stability studies – and performance testing”, Sehan wrote.
Genentech also commented on the use of alternative devices but has different concerns. In feedback to the FDA, Earl Dye, director of technical regulatory policy at Genentech, writes that the Agency should clarify how biosimilar manufacturers must label differences from reference products.
A warmer welcome
Although Novo Nordisk and Genentech highlighted potential problems others have welcomed the device flexibility. Kevin Nicholson, vice president at the National Association of Chain Drug Stores, told the FDA it supports the policy and Teva has also spoken out in favour of the draft plan.
“[Device flexibility] allows me to create some features and benefits of my own that can help with the product. That makes a lot of sense”, William Marth, CEO of Teva North America, said at an investor conference last month.
Teva is one of several potentially interested parties that, as of yesterday’s deadline, is yet to post written, public feedback to the FDA. So far 39 companies and organisations have commented.
The FDA is holding a full-day hearing on May 11 in Silver Spring, Maryland to allow others the chance to comment on its draft guidance documents. Information exchanged at the hearing will shape final guidance and future biosimilar regulations.