BIO, the Biotechnology Industry Organisation, and the Colorado Bioscience Association commended Colorado Governor John Hickenlooper for signing Senate Bill 71.
The bill will allow pharmacists to swap a prescribed biologic for a biosimilar judged by the US FDA to be “interchangeable.” However the law will have no immediate effect as the FDA has yet to create a clear pathway for biosimilar makers to apply for interchangeable status.
A Pfizer executive last week accused the FDA of “falling short in terms of how they define interchangeability.”
In February the regulator called on industry to comment on what data should be submitted in applications.
When interchangeability application rules are decided, there will still be caveats to substitutions.
Under the bill, doctors will have the right to block substitutions and insist on a named brand, and patients and doctors will be informed of any switches.
A study has shown doctors’ willingness to change from a reference biologic to a biosimilar differs by specialty. Endocrinologists were found to be the most resistant to substitutions, perhaps out of concern about immunogenic reactions.
“Senate Bill 71 enjoys the support of physicians across the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record,” said Jim Greenwood, BIO President.
He added that BIO believes interchangeable biologics “are not generics. Even slight changes to a biologic drug can change its properties entirely.
“Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same are wrong.”
The bill passed in the Colorado House of Representatives with a vote of 63-1 (with one abstention), and 43-1 in the State Senate.
“We’re really pleased to see Colorado leading the way in adopting policies that not only support a growing industry in our state, but more importantly allow patients access to safe, effective cutting-edge therapies when the first interchangeable biologics are approved by the FDA,” said April Giles, President, Colorado Bioscience Association.