Dive Brief:
- Food and Drug Administration Commissioner Scott Gottlieb told an audience at the CNBC Healthy Returns conference on Wednesday that the agency is going to address the challenges facing biosimilars manufacturers, including "taking a hard look at interchangeability."
- "I think it's still early days," commented Gottlieb on biosimilars. "I think a lot of the initial estimates in how much we would save on biosimilars in advance of legislation probably weren't realistic ... I think we will see a lot of biosimilars competition come on the market and that we will see more consumer and buyer acceptance."
- As many as a dozen new policies are on the way to spur biologics drugmakers to tighten up their manufacturing processes.
Dive Insight:
Among the many initiatives Gottlieb has put on the agenda since taking over as FDA Commissioner is the speedy approval of biosimilars.
The FDA has approved nine biosimilars to date, but only three have reached the market due to ongoing patent litigation and deals between companies that have kept competition to a minimum.
Studies have estimated the copycat biologics could help save the U.S. healthcare system anywhere between $24 billion to as much as $150 billion over the next ten years. Yet, a number of factors — including contracts from payers — have kept biosimilars from entering the market.
There have been other barriers to entry as well: most of the biosimilars that have entered the market to date are priced at only a small discount to the reference product instead of the 80% to 90% discount now seen with generic small molecule drugs.
Gottlieb has been outspoken about casting blame for the lack of competition, criticizing payers and pharmacy benefit managers in a recent speech.
"There was a lot of reluctance to use generic drugs when they first came on the market. We're going to be initiating a lot of policies to stimulate biosimilars development. We're taking a hard look at how we determine interchangeability," said Gottlieb at the event.
The commissioner noted that there is much variance in lot-to-lot manufacturing of existing biologics, as well as in the variability of biologics over time — what he referred to as "drift in the formulation."
"Those [variances] don't seem to have clinical consequences, but that drift makes it hard to copy those drugs. If you have a moving target on the market and you want to come in and create a biosimilars to copy it you have to study your biosimilars against more drugs because there are more patients because there is more variability," he added.
Gottlieb said the FDA is going to put out a set of policies — as many as a dozen — that will target branded biologic drugmakers to "tighten up their manufacturing" and create less variance within the reference products.
"We think once we do that, it's going to be easier to copy those drug with smaller studies," the policymaker said.
Gottlieb credited "public shaming" and policy changes for preventing companies from making small tweaks to their formulations to extend the patent life of their drugs, a problem frequently seen in the past with small molecule drugs.
He estimated that it currently costs about $300 million to develop a biosimilar — much more than a generic small molecule, but that the agency is working to put policies in place that will help bring that cost down closer to $100 million.