FDA issues warning over biosimilars availability block

The US Food and Drug Administration (FDA) has warned companies that attempt to block cheaper biosimilar alternatives from being made available in the US.
The cost of insulin has steadily increased in the US and in a bid to tackle this, cheaper versions of insulin medications have been developed, known as biosimilars.
Biosimilar medications, which include insulins, are not protected by patents, and could be used to help make significant cost savings. Last year, NHS England published a report calling for more biosimilar medication prescriptions to be made available.
Currently there are few biosimilar alternatives available, and the FDA has said some companies have been using tactics to block biosimilars progressing to market.
Scott Gottlieb, the FDA’s Commissioner, has issued a statement vowing to crack down on any firms found to be carrying out anti-competitive tactics and pricing practices.
He was warned against companies which use limited and abuse limited distribution systems to hide anti-competitive behaviour and fail to supply biosimilar developers with the reference samples required for suitable testing.
Mr Gottlieb said: “This is just a start. We’re going to be monitoring these markets. And we’ll be taking additional actions. We’re actively evaluating how we can make it easier for biosimilar manufacturers to use reference products from outside the US, where prices may be cheaper and reference products more accessible.”
The FDA has already publicly released the names of companies that have been blocking access to small-molecule generics and he has vowed to do the same if the behaviour continues with biosimilars.
Mr Gottlieb is also is planning to stamp out soaring insulin prices. He said: “This is a watershed moment for insulin products, which millions of American take each day to maintain stable blood glucose. These products can be open to brisk competition from biosimilars.”