Good morning and happy Friday, readers! This is Sy.
The Food and Drug Administration (FDA) continued its potentially record-breaking pace of new drug approvals Thursday, green lighting the first-ever “biosimilar” copycat of a cancer drug. The new treatment, U.S. biotech Amgen’s Mvasi, has a big target in its crosshairs: Avastin, a versatile cancer therapy from drug maker Roche that rings in nearly $7 billion in global annual sales, including $3 billion in America.
Avastin is, like many cancer drugs, extremely expensive. And that was one of the motivations for introducing a clinically-proven competitor like Mvasi (also known as bevacizumab-awwb) to the market. Biosimilars are approximate copies of “biologic” drugs that must prove themselves “similar” the branded product they’re attempting to mimic. Mvasi is approved in all of the same cancer indications as Avastin (colorectal, lung, brain, kidney, and cervical cancer).
“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies,” said FDA Commissioner Scott Gottlieb in a statement. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.”
Biosimilars haven’t been on the U.S. market for very long even though they’re been around in other countries for more than a decade. The first one was only approved in 2015. The big question about them is just how much they might lower health care spending—and whether their competitive pricing will ultimately translate to savings for patients.
For instance, some biosimilars have been introduced at relatively modest 15% discounts to branded product list prices; others, like Merck’s recently-approved copy of Johnson & Johnson best-seller Remicade, can come with 35% discounts.
It’s unclear how Amgen and partner Allergan will price Mvasi. But, even if it proves significantly cheaper than Avastin, there’s a chance that those discounts will mostly be seen by middlemen such as pharmacy benefits managers and insurance companies during behind-the-scenes negotiations.
Read on for the day’s news, and enjoy your weekend!
This startup is trying to 3D print human organs. Healthcare IT News reports that upstart Prellis Biologics has raised $1.8 million in seed funding to embark on an audacious quest to 3D print human organs. The company was founded by two scientists with backgrounds in stem cell biology and 3D tissue imaging—and the firm says it’s figuring out solutions to one of the most difficult parts of tissue printing, i.e. creating the inner ecosystem that provides nutrition and oxygen to cells. (Healthcare IT News)
Pharma fears Maryland price gouging law. On October 1, a first-of-its kind Maryland law on drug price gouging goes into effect. Naturally, pharma companies are approaching it with some trepidation and chasing a court injunction that would prevent it from taking effect. Under the law, the Maryland Attorney General’s office would review complaints about “unconscionable” price increases for critical generic treatments. (Reuters)
THE BIG PICTURE
101,000 people are waiting for a kidney transplant. Pop star Selena Gomez revealed on Thursday that she had been recovering from kidney transplant surgery over the summer, which was necessitated because she suffers from the autoimmune disorder Lupus. Gomez was fortunate to have a best friend who was a biological match and willing to offer up a kidney; however, more than 101,000 people are on waiting lists for kidney transplants in the U.S., and only 17,000 receive them in any given year. (Fortune)