As an active patient advocate, I’m constantly studying up on the latest treatment innovations for psoriasis and psoriatic arthritis. The hottest topic right now: new psoriasis biosimilar treatments.
I am currently taking a biologic to treat my psoriasis, psoriatic arthritis and other inflammatory diseases. However, with five FDA-approved biosimilars on the market, I’m left to consider whether I should change my treatment.
What are Biologics and Biosimilars?
Open your medicine cabinet, and you’re likely to find what pharmacists classify as small-molecule drugs. Think aspirin and allergy medication.
“Small-molecule drugs are, as you might expect, small and fairly simple in their structure,” Popular Science explains. “They are synthesized from chemicals in a consistent process so that manufacturers can be sure that each pill has the same effect every time.”
In contrast to small molecule drugs, biologics are a type of medicine that are “made from living cells through highly complex manufacturing processes.” These cells can be derived from animal and human cells or even microorganisms, such as bacteria or yeast. Because they’re living things, they’re much more complicated and difficult to develop.
A biosimilar, which is also made of living cells or organisms, is a drug that is “similar” to another biologic that has been deemed safe and approved by the FDA. Biosimilars are sold as competition for a reference biologic.
Biosimilar: Competition on Price
Biosimilars have hit the market as a way to increase competition with biologics. Patients living with psoriasis and psoriatic arthritis know all too well the high cost and burden associated with the disease. The annual economic strain of psoriasis and psoriatic arthritis is substantial — with estimates as high as $135 billion per year.
Psoriasis biosimilar treatments are an attempt to bring down costs and increase competition. By making biosimilar cheaper, you make them more accessible to more people.
Just like generic drugs, biosimilars are cheaper because they haven’t gone through the original research and development process. Manufacturers don’t spend as much money on clinical trials and research as with biologic. The original drug makers of biologics had to go through extensive processes for new development that cost hundreds of millions of dollars. Biosimilars can save the money for most of these steps because it piggybacks off the biologic drug.
Biosimilars: Not the Same as Generic Drugs
But, biosimilars are not equivalent to generic small-molecule drugs. As Fortune explains:
“Producing generic small-molecule drugs is relatively simple–it’s like following a recipe with standard ingredients. Biosimilars are much more challenging because living cells are highly sensitive to their environments, and manufacturers have to create their own, unique process to coax these cells to produce an identical outcome to an existing treatment.”
“If creating a generic drug is like designing a tricycle,” Asthika Goonewardene, a senior healthcare analyst with Bloomberg Intelligence, says “then a biosimilar is like building a spaceship, in terms of complexity and size.”
FDA Approval of Psoriasis Biosimilar Treatments
To gain FDA approval, psoriasis biosimilar treatments must meet two criteria.
- The medication must be highly-similar to the reference biologic.
- It cannot have any clinically meaningful differences in terms of safety or efficacy from the reference biologic.
“The FDA will only approve a biosimilar product if it has the same mechanism of action, route of administration, dosage form, and strength as the reference product.,” the FDA explains on its website. “Additionally, a biosimilar can only be approved for the indications and conditions of use that have been previously approved for the reference product.”
Biosimilar vs. Biologic: Who Should Decide?
Health care stakeholders need to find common ground in a way that provides access to safe and effective treatments, while also reducing the out-of-pocket costs to patients. We need a system that not only encourages innovation, but also expands access to all patients.
The decision between a biologic and a biosimilar should be left to doctors and patients.
Patients shouldn’t be forced to switch to a biosimilar simply because insurance doesn’t want to pay for the prescribed biologic.
My Verdict on Psoriasis Biosimilar Treatments
Yes, cost is very important, but it should never take precedence over safety. Before I can make a decision on whether I would switch to one of the psoriasis biosimilar treatments, I still need more answers.
- Who is monitoring psoriasis biosimilar treatments?
- How available will they be?
- What are the side effects?
- What are the risks?
- What is the cost savings?
I will continue to do my homework. My bottom line will always be safety over anything else.