Earlier this year, the FDA released its draft guidance for the biosimilars industry, allowing the drugs to use different delivery devices than their initial reference products. But an exec at Novo Nordisk ($NVO) said that could imperil the drugs' safety.
Novo vice president James C. Shehan wrote in feedback to the FDA that switching up delivery could open up new vectors for unsafe treatments, In-PharmaTechnologist reports. As written, the proposed guidance allows for delivery variation, but only if "the proposed product meets the statutory standard for biosimilarity, and adequate performance data for the delivery device or container closure system are provided."
But that doesn't go far enough, Shehan wrote. Back in 1998, a reformulation of anemia treatment Eprex was linked to development of pure red cell aplasia, Shehan points out, and the likely culprit was the change to prefilled syringes with uncoated rubber stoppers.
To avoid that sort of dangerous outcome, Shehan recommends the FDA amend its guidance to mandate that any proposed change in drug delivery method be supported by data. "The guidance should state that the biosimilar applicant will always need to conduct compatibility testing--including extractable/leachable studies and stability studies--and performance testing," he wrote to the FDA, as quoted by In-PharmaTechnologist.
But not every biosimilar-maker was critical of the device flexibility provision. Teva ($TEVA) North America CEO William Marth told investors that being able to swap delivery platforms allows drug developers to improve treatments by adding features not present in their reference products.
The deadline for written feedback on the draft guidance was April 16, and the FDA's May 11 hearing on the draft will likely be closely watched. The industry has taken notice of the growing opportunities in biosimilars, and Reuters estimates the market to reach $3.7 billion by 2015, after measuring $243 million in 2010.
- check out In-PharmaTechnologist's report
- here's a Q&A on the FDA's draft guidance