After eleven months of testing, the U.S. Food and Drug Administration (FDA) approved Ogiviri, the first “biosimilar” drug for patients suffering from breast or metastatic stomach cancer.
Mylan and Biocon, two multinational pharmaceutical companies, submitted the product for FDA approval in January 2017. FDA granted the companies permission to sell Ogiviri in December 2017.
Unlike generic drugs, biosimilars are not chemically identical to the drugs on which they are based. Instead of copying a drug’s composition, biosimilars replicate the referenced product’s effects.
Explaining Biosimilar Approval
Richard Dolinar, M.D., a senior fellow for health care policy at The Heartland Institute, which publishes Budget & Tax News, says FDA’s biosimilar approval processes are rigorous.
“The FDA uses a ‘totality of evidence’ standard,” Dolinar said. “In other words, the company meets with the FDA early on and says, ‘We have this drug; it’s a biosimilar to x-y-z brand-name. We plan on doing these studies. What do you recommend?’
“It’s a process where they meet periodically and, as the data evolves, the FDA is monitoring,” Dolinar said. “The FDA may suggest, ‘We need more of this or more of that study,’ and they work their way through the process.”
Says Process Is Rigged
Steve Pociask, president of the American Consumer Institute, says some companies are using loopholes in FDA regulations to block the entry of new players into the market.
“The brand-name manufacturers essentially are preventing the generic manufacturers from buying samples of the originating drug,” Pociask said. “Without the critical samples, the biosimilars can’t be tested for effectiveness, which all prevents the FDA from obtaining the necessary information it needs for approval. It’s a huge loophole, and brand manufacturers know it.”
In these cases, biosimilar manufacturers can’t buy sample drugs to test, Pociask says, limiting their ability to pass FDA scrutiny.
“What’s been happening is that the brand-name manufacturers have been able to limit or impede the ability of the rivals to buy these sample drugs, and that’s because the FDA has this Risk Evaluation and Mitigation Strategy program that allows the brand-name manufacturers to restrict the channel distribution,” Pociask said. “They can say, ‘Because of safety, we’re only going to allow certain hospitals to have the drug.’
“They can block competition and keep prices higher, which means that patients, hospitals, insurers, and government plans will pay significantly more,” Pociask said.
‘Prices Come Down’
Dolinar says streamlining the biosimilar approval process would decrease patients’ costs and increase access.
“I think they will add competition to the marketplace,” Dolinar said. “Whenever you have competition, prices come down. I think they’ll be beneficial in increasing patient access to expensive medications at a cheaper rate.”