Biosimilars at a glance


Florida is among at least one of 15 states where major pharmaceutical companies are trying to pass legislation to limit the use of a new wave of drugs known as biosimilars.

Q: What are biosimilars?

A: They are essentially “generic” drugs that seek to copy a group of complex drugs known as biologics used to treat chronic illnesses such as cancer, rheumatoid arthritis and multiple sclerosis. Biologics differ from older chemical-based drugs in that they are proteins made using processes involving living organisms or systems.

Biologics are growing in use and as the patents for the older biologics expire, biosimilar makers want to move into the market. Biosimilar drugs could provide treatment at a 30 percent to 40 percent lower cost than the brand-name biologics, according to estimates from federal officials and industry analysts.

Q: Are biosimilars available now?

A: Not in the United States. They are used in Europe.

Q: What does the Florida legislation do?

A: The bills (HB 365 and SB 732) seek to set Florida standards for dispensing the drugs. The bills would require pharmacists to notify doctors within five days if they substitute a biosimilar. It would also require pharmacists to keep records of the substitution for at least two years.

Q: What’s next?

A: The House bill is ready for a floor vote, while the Senate measure still needs to clear several committees. Their passage looks likely since the bills are being sponsored by influential lawmakers who oversee health care spending, Rep. Matt Hudson, R-Naples, and Sen. Denise Grimsley.

Last modified: April 6, 2013