More States Demand Notification to Use Biosimilar Drugs
By Michael Ollove, Stateline
Without the medicine Rachelle Crow takes for her rheumatoid arthritis, the 29-year-old Michigan woman's face would frequently feel as if it were engulfed in flames. She would barely be able to crawl out of bed. She would have trouble opening or closing her fists or lifting her 3-year-old daughter.
Crow can do all those things thanks to Cimzia, one of a highly complex, usually expensive class of drugs known as biologics that derive from living organisms. Cimzia is recommended for women, like Crow, who are trying to get pregnant.
This cross-section of a blood vessel illustrates a condition called chronic allograft vasculopathy (CAV), a major factor limiting long-term survival following heart transplants. Image: Nathalie Accart-Gris/Novartis
What keeps her up at night is a fear that a pharmacy could substitute a cheaper, not-quite identical drug for Cimzia without her or her doctor’s knowledge. It's not only a return of her worst symptoms that she worries about. "If another medicine were substituted without telling me or my doctor, it could put my pregnancy at risk," she said.
Fears like Crow's have helped propel legislative attempts in many states this year to make sure that patients and doctors are notified whenever imitations deemed "interchangeable" by the US Food and Drug Administration (FDA) are substituted for brand-name biologics. Already, Colorado has passed a notification law, and Utah has revised its earlier law. More than a dozen states are considering comparable measures.
Notification bills began popping up in states two years ago, but most were defeated in the face of opposition from manufacturers of biologic copies, which are called biosimilars, and from organizations representing pharmacists, who objected to the extra workload notification requirements might entail.
Thirteen states killed or tabled bills the last two years. Only eight states (Delaware, Florida, Indiana, Massachusetts, North Dakota, Oregon, Virginia and Utah) ended up enacting laws. A ninth, California, passed a bill through the legislature only to see it vetoed by Democratic Gov. Jerry Brown.
But the legislative climate for enacting notification law is different now that biosimilars are finally coming on the market.
Earlier this month, the FDA for the first time approved a biosimilar. Manufactured by Sandoz, a division of the pharmaceutical company Novartis, Zarxio is the biosimilar version of Amgen Inc.’s anti-infection biologic Neupogen. Neupogen, which was licensed in 1991, is used for certain cancer patients undergoing chemotherapy or bone marrow transplantation among others.
The FDA confirms that at least three other biosimilars are awaiting FDA approval. Many others are in development.
The arrival of biosimilars has been eagerly awaited by patients and health consumer groups.
For Julie Wiles, a Houston resident with rheumatoid arthritis, biosimilars couldn't come soon enough. Through a pharmacy assistance program, she was able to get the biologic Enbrel.
"I did not have flare-ups or joint pain" after starting on the Enbrel, Wiles said. "I could get up in the morning. The biologic was literally changing my life. I felt normal."
But after six or seven months, the program was no longer able to supply her Enbrel, and her insurance company would not pay for the drug.
"That's when I learned it would cost me $2,500 an injection, and I needed an injection every week," Wiles said. She went back on conventional medications, which don't control her symptoms nearly as well.
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