The FDA's draft guidance on biosimilars, released earlier this year, allows for drug developers to switch up delivery methods from original reference products. And Pennsylvania's West Pharmaceutical Services ($WST) is eyeing profits by taking advantage of the leeway.
As in-PharmaTechnologist reports, West is telling investors that offering unique delivery platforms for biosimilars will help it compete with reference drugs and reap profits around the world. In particular, West is targeting Asia, which has a large population and "relatively lax regulatory systems," one of its execs told in-PharmaTechnologist.
And West isn't alone in its optimism about the future of biosimilars, especially if the FDA indeed provides delivery leeway for developers. Reuters estimates that the world biosimilars market will swell to $3.7 billion by 2015 after grossing $243 million in 2010.
However, not everyone has met the draft guidance with such enthusiasm. Last month, a Novo Nordisk ($NVO) exec questioned whether allowing drug developers to switch delivery platforms without reapplying for approval was safe for patients. Novo Vice President James C. Shehan reminded the FDA that, back in 1998, a reformulated anemia treatment caused red cell aplasia in some patients because it was delivered in syringes with uncoated rubber stoppers. That could have been avoided with more oversight, he said.
The deadline for written feedback on the draft guidance was April 16, and the FDA held a public hearing on the issue on May 11. The agency is expected to make a decision on the new rules later this year.