You may not have realized it, but there’s a good chance you’ve been treated with a biologic at some point in your life.
Biologics aren’t new, and they’re used for a wide range of medical conditions.
For example, vaccines contain biologics.
Insulin is a biologic that has been used for nearly a century to treat diabetes.
Many important cancer therapies are biologics, including trastuzumab (Herceptin) and bevacizumab (Avastin).
Other biologics help slow the progression of autoimmune diseases and other conditions.
Biologics differ from traditional drugs in important ways.
Generally, biologics are created inside a living system, such as a microorganism or cell, and they tend to have large, complex molecular structures that may not be entirely understood. They often contain DNA.
In contrast, most conventional drugs are produced through chemical synthesis, and their entire chemical structure can be analyzed and understood.
If you need them, biologics can be a game changer.
But out-of-pocket expenses for biologics can come between some patients and their treatment.
Biologics: Revolutionary but costly
Biologics add billions to healthcare costs.
In 2011, global sales for just one, infliximab (Remicade), reached $7.19 billion.
In the United States, less than 1 percent of prescriptions are for biologics, but they account for 28 percent of prescription drug spending.
Dr. Jeff Hausfeld, chief medical officer of BioFactura, a biopharmaceutical development company, told Healthline that biologics can cost $50,000 to $500,000 a year.
What makes them so expensive?
Hausfeld explained that it takes a long time to make one from scratch. Many fail in drug trials.
“We estimate it takes over $3 billion to bring a novel drug from inception to market,” Hausfeld continued.
“They have to pass many different regulatory hurdles for FDA approval. Even after they’re on the market, they still have to be monitored. We learn more about the side effects and adverse events in the wider population than we see in clinical trials.”
Biosimilars may soon change the biologic landscape.
They’re often compared to generic drugs, but it’s not that simple.
Generic drugs are identical copies of their brand-name counterparts, whereas biosimilars are not required to be exactly like the approved branded biologic product they’re based on.
Dr. Santosh Kesari, Ph.D., is a neurologist, neuro-oncologist, and chair of the Department of Translational Neuro-Oncology and Neurotherapeutics at the John Wayne Cancer Institute.
In an interview with Healthline, he explained that generics involve small molecule drugs, made through chemical synthesis.
Like other biologics, biosimilars are made from living cells and are structurally much more complex.
“In biosimilars, the functional part is smaller. As long as the functional part is the same, the other parts can be different. The reason this is important is if you have the same strict criteria as generics, no one would make them,” said Kesari.
Despite the differences, they should be just as effective.
Biosimilars are subject to FDA approval and must produce the same clinical result as the reference product.
“The legislation that allows this is a great thing,” continued Kesari. “Otherwise it would have been impossible. The fact that we have a biosimilar pathway is good for the healthcare system. It’s good for patients and it will reduce costs.”
The legislation that encouraged biosimilars in the United States was the Biologics Price Competition and Innovation Act (BPCIA) of 2009. It was signed into law through the Affordable Care Act (ACA).
In March of 2015, filgrastim-sndz (Zarxio) became the first biosimilar approved by the FDA.
The treatment helps maintain blood counts and prevent infection while patients are on chemotherapy. Its reference drug is Neupogen.
Earlier this year, the FDA approved infliximab-dyyb (Inflectra), which is used to treat a variety of conditions, including Crohn’s disease and some forms of arthritis. Its reference drug is infliximab (Remicade).
That was followed by approval of etanercept-szzs (Erelzi) to treat rheumatoid arthritis and other inflammatory diseases. Its reference drug is etanercept (Enbrel).
This is only the beginning.
What it means for patients and the healthcare system
“Researchers have estimated that if only 11 biosimilars came to market in the next 10 years, healthcare payers, patients, and/or insurance companies, could realize savings upward of $250 billion dollars,” said Hausfeld.
To illustrate the point, he refers to the Hatch-Waxman Act of 1984. That’s the legislation that encouraged the manufacture of generic drugs.
Hausfeld recalls practicing in the 1980s when generics first came on the market. Many of his patients insisted on branded drugs.
“Insurance companies didn’t catch on to tiered pricing for several years,” he added.
“There wasn’t much cost difference between branded and generic drugs. Now 90 percent of prescriptions are filled with generics. That’s a staggering figure. Patients, doctors, and third-party payers now realize generics are safe. They do a good job at a lower cost. Amplify that by a thousand fold and you’ll begin to understand the opportunity with biologics and biosimilars,” explained Hausfeld, whose company develops and manufactures biosimilars for phase I clinical trials.
He won’t be surprised to see at least 11 new biosimilars within a decade.
“Many are realizing how biologics have transformed the lives of people with cancer, rheumatoid arthritis, lupus, and other debilitating diseases. These conditions are complex and difficult to treat. Biologics are a godsend for these patients.”
Hausfeld said biosimilars will improve patient access to these medications.
“If you have a multiple sclerosis patient who does well with Tysabri, for instance, but has to decide between putting gas in the car and getting the drug for the month, a biosimilar could be life changing,” said Hausfeld.
“The first drug we’re [BioFactura] bringing to market is to prevent and treat respiratory syncytial virus,” he continued. The reference drug is Synagis.
The virus primarily affects older adults and premature infants.
It can kill infants born prematurely or leave them hospitalized for weeks. Untreated, it can lead to long-term pulmonary and immunologic difficulties.
Drug costs led to changing guidelines and fewer premature infants getting the drug. That can translate into unnecessary hospital stays, said Hausfeld.
“You can imagine the emotional and economic consequences of a baby in the hospital and parents missing work for weeks,” he said. “So if we can bring a biosimilar to market, insurance companies can recalculate because it makes sense to prevent the disease.”
Hausfeld said millions of lives will change as a result of the ability to make these drugs.
“Just as with the adaption to generics, there’ll be an adaption to biosimilars. But it will be accelerated because the price differential will be much more compelling for physicians, insurance companies, and patients,” he said.