In this 21st century digital world, it seems like every day a new word or expression surfaces and goes viral. Badass, lit, basic, I can’t keep up. But, when it comes to health care, I try my best! So, I’ve learned that biosimilars are intended to be almost identical to brand-name drugs, essentially generic versions, offering the same outcomes at 20-30 percent less cost.
Even though biosimilars are made of living cells, a new study published in the Annals of Internal Medicine that looked at one class of biosimilars, indicates that they are safe and effective. Dr. Caleb Alexander, a study author, told Stat news, that after looking at 19 studies, researchers found that the biosimilar drugs for rheumatoid arthritis, inflammatory bowel disease, and psoriasis are essentially “comparable” to the brand-name biologics.
But, to date, according to Stat news, the FDA has only approved two biosimilars. The alleged concern is that because biosimilars are made of living cells they are slightly different from the brand-name drugs, and those differences could affect their safety. Of course, the drug industry is concerned about the competition that would drive down profits and is investing heavily in keeping biosimilars from being approved.
Amgen recently won a federal appeals court challenge against a biosimilar manufacturer aimed at slowing down approval of biosimilars. In short, the court prevented the biosimilar manufacturer from marketing its biosimilar drug; it affirmed the lower court opinion that the Biologics Price Competition and Innovations Act keeps manufacturers of biosimilars who receive FDA approval for their drugs from marketing their drugs until 180-days after they give notice of their marketing license, which they only get once the drug is approved.
This 180-day post-FDA-approval and marketing license period gives brand-name drug manufacturers additional time to sell their brand-name drugs without competition and come up with patent and other challenges to biosimilars.
More research needs to be done around the safety of biosimilars. And, policies need to evolve to speed up their post-approval entry into the market. Biosimilars open the door to billions of dollars of savings on some critically important and very expensive drugs, like Remicade and Humira, among others.
Here’s more from Just Care: