FDA Forms Biosimilar Work Group

In the end we are all separate: our stories, no matter how similar, come to a fork and diverge. We are drawn to each other because of our similarities, but it is our differences we must learn to respect.

– Unknown

As I’ve mentioned before, the recent healthcare reform act (technically the “Patient Protection and Affordable Care Act”) created a pathway for biosimilar approvals.

According to the Bureau of National Affairs, the FDA has already formed a work group to flesh out the details and provide guidance on how biosimilar products will be evaluated and approved.  The group is composed of officials from both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).  They have a daunting task; the challenges around developing some biologics are remarkable.  Of course, the 800-pound gorilla in the room is how to define what makes one biologic interchangeable with another.

Woodcock said there are some issues for biosimilars within the statute that must be addressed. Specifically, there is a standard in the statute allowing a biosimilar to be interchangeable with the brand product. This means there is no clinical difference between the drugs, Woodcock said. “That is a scientific bar that we have to figure out how to demonstrate.”

FDA also needs to figure out what biosimilars will be called, Woodcock said. These are not like small molecules and they cannot have the same name if they are not interchangeable, she said.

Given that the pathway for biosimilar products is new, it will be quite some time before we truly understand its impact, but you can bet money that both the industry and the public will not wait to voice opinions.