A bill requiring that a Colorado patient’s doctor be notified if a pharmacist substitutes a biosimilar for a brand-name biotech drug cleared its first committee at the state Legislature Tuesday.
The bill requires pharmacists to notify doctors when they substitute a biosimilar, which should start coming to market in 2015 in the US and could save billions of dollars in health spending. They must also keep a record for five years.
The bill’s backers, including drug companies and some patient advocates, say doctors need to know because biosimilars are not exact replicas.
Pharmacists and generic drug makers on Tuesday countered that the innovators are throwing up roadblocks to make billions from blockbuster treatments long after they go “off patent” in coming years.
Similar legislation in dozens of states “is a ploy by the innovators to thwart competition,” said Christine Simmon, senior vice president at the Generic Pharmaceutical Association. The House health and environment committee passed the bill 10-1.
At stake are the next round of cancer, diabetes, arthritis and other drugs scheduled to lose exclusivity and face competition when the FDA approves them. The FDA has said it will approve biosimilars when tests prove they are “interchangeable” with the original brand name.
Representatives of Sandoz, a major generic maker, said biosimilars have been proved safe and equally effective in 50 million patient days in Europe, which already allows them. McCamish, the Sandoz executive, left encouraged that four members of the committee voted to strike doctor notification suggests there’s a chance on the House floor and in the state senate to convince others, he said.
Amgen and other bill proponents said the complex, life-threatening cases the biologic drugs treat require close communication between doctor, pharmacist and patient.
Backers of the bill said they want access to cheaper, similar drugs, but see the notification and five years of record-keeping as a “manageable work load” for doctors and pharmacists.
“I believe a doctor, a pharmacist and a patient should be in communication as a team for the patient’s safety,” said sponsor Rep. Sue Schafer, D-Wheat Ridge.
Source: Denver Business Journal, Denver Post