FDAnews Drug Daily Bulletin

Colorado Biosimilars Bill Closely Mirrors Compromise Substitution Language

Jan. 27, 2015

Colorado lawmakers have introduced a biosimilar substitution bill that closely mirrors at least one aspect of compromise language unveiled by industry leaders last month — elimination of prescriber notification in favor of entering a switch into an electronic database.

Under the bill, pharmacists will only notify prescribers that they’ve switched a patient from brand to biosimilar if no database is available to make note of a swap. Otherwise, the prescribing physician will only learn that a patient has been switched if they check the database.

The legislation was introduced into a state Senate committee two weeks ago.

The Generic Pharmaceuticals Association and some biosimilars makers have pushed for this kind of language in other state substitution bills. So far, eight states have passed laws allowing pharmacists to switch patients to a biosimilar, most without the notification requirements. However, GPhA has criticized a North Dakota law that requires prescriber notification and allows patients to refuse the biosimilar version.

Proponents of the North Dakota law and ones like it argue that physicians should be notified because biosimilars are not exact copies of brand biologic. GPhA counters that the therapies should be treated as generics to facilitate market entry and because biosimilar approval means the FDA has found no clinically meaningful difference from the brand.

While only the FDA can sign off on biologics and biosimilars, patient-switching policies are left to the states.

The Colorado bill, which has bipartisan support, is the first to be introduced by a state legislature since GPhA unveiled compromise language by brand and biosimilar manufacturers. That language removes prescriber notification in favor of database entry.

In its current form, the Colorado bill would only allow a swap to be made if the biosimilar has been granted the higher regulatory status of an interchangeable. Pharmacists would be required to make the switch unless the physician specifies that the patient is only to be given the reference version or if the reference therapy is cheaper.

This is the second time that the state legislature has taken up biosimilar substitution. A prior attempt failed two years ago, largely over objections to more stringent notification requirements, state Rep. Lois Landgraf (R-Fountain), a co-sponsor of the current bill, said.

Other co-sponsors expressed optimism that the bill will pass, but note it is early in the process and the final language could change. State Rep. Elizabeth McCann (D-Denver) expects the bill could reach Democratic Governor John Hickenlooper’s desk in five to six weeks.

Read the bill at www.fdanews.com/01-20-15-Colorado-Biosimilars-Bill.pdf. — Bryan Koenig