Biosimilars Bill Passes House, Heads To Governor

Pharmacists would be able to substitute an interchangeable biosimilar drug for a prescribed name-brand product under a bill passed by the Indiana House of Representatives on Tuesday.

The legislation, authored by Sen. Brandt Hershman, R-Buck Creek, creates a series of steps to ensure the safety of automatic substitution of biosimilar medications.

“While the science behind these drugs is very complex, this issue is very simple from policy standpoint,” said Rep. Ed Clere, the House sponsor for the bill. “The bill ensures communication between providers, patients, and pharmacists, during the dispensing process.”

Senate Bill 262 includes the five principles supported by BIO, the Biotechnology Industry Organization, which are:

• The FDA must deem a drug interchangeable before it can be substituted.
• The physician must allow for substitution.
• The pharmacist must notify the patient of the substitution.
• The pharmacist must notify the doctor of the substitution.
• Both the pharmacist and the doctor must keep a record of the substitution.
• The bill is similar to legislation that was passed by the House during last year’s legislative session but was killed by the Senate.

“The Senate incorporated several changes this year to preserve the five principles, while also addressing concerns that have resulted in some of the folks who opposed the legislation last year, now switching and supporting the legislation this year,” Clere said while addressing the House. “So we have an even better bill than what most of you supported last year.”

The legislation now moves to the governor’s office for consideration.

Jacob Rund is a reporter for TheStatehouseFile.com, a news website powered by Franklin College Journalism students.