The number ofbiosimilarsapproved by the Food and Drug Administration (FDA) continues to grow in the United States, and they are slowly becoming available to consumers.
In late August, the FDA approvedCyltezo(adalimumab-adbm), a second biosimilar toHumira(adalimumab). But like the first biosimilar,Amjevita(adalimumab-atto), which was approved in September 2016, it is not yet available to U.S. consumers because of pending patent litigation with AbbVie, the manufacturer ofHumira.
Cyltezocomes in a pre-filled syringe for subcutaneous injection and is approved to treat the same chronic inflammatory diseases asHumira, including rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis and inflammatory bowel disease (IBD).
Meanwhile, Merck launchedRenflexis(infliximab–abda),a biosimilar toRemicade(英夫利昔单抗)于7月下旬上市，而几个月前该药物已于4月获得FDA批准。That makes two biosimilar versions ofRemicadecurrently available to U.S. consumers. The first,Inflectra(infliximab-dyyb), marketed by Pfizer, was approved in April 2016 and came to market inNovember 2016. LikeRemicade, both biosimilars are intravenous infusions and are approved to treat RA, PsA, AS, psoriasis and IBD.
Biologics vs. Biosimilars
The Affordable Care Act (ACA) created a pathway for biosimilars, biological products that are shown to be “highly similar” or “interchangeable” with an already FDA-licensed biological product. The intention was to make biologics, which can cost tens of thousands of dollars, more affordable.
Unlike generics, biosimilars aren’t perfect copies of the original drug. Biologics are derived from living cells and are impossible to replicate exactly. But rigorous comparative testing has shown that biosimilars are as safe and effective as the originals, explains Jonathan Kay, MD, professor of medicine at University of Massachusetts Medical School in Worcester.
“They’re identical in every way that matters – potency, dosing, method of administration and clinical effects,” he says. The lower the cost of the biosimilar compared to the originator drug, “the more accessible it should be to patients.”
密西根大学学术医学中心密西根医学风湿病科主任大卫·福克斯医学博士对此表示赞同。“我们对生物仿制药没有医学需求。The benefit would potentially be a lowering of the price of biologics,” he explains.
“The term ‘biosimilar’ is appropriate, because the medications may not be as identical as one expects with generic drugs,” Dr. Fox says. “Subtleties of the manufacturing process can lead to small differences between a biologic and a biosimilar that may be hard to anticipate or detect.
“Until more patients are treated, I would be reluctant to switch a patient who is stable on their current biologics,” Dr. Fox adds, noting it’s “just about saving money.”
Big savings?
Biologics are among the world’s most expensive drugs. Biosimilars cost less to produce because, like generics, they’re copies of drugs that already exist. According to Joshua Cohen, PhD, a researcher at Tufts Center for the Study of Drug Development in Boston, prices for biosimilars in Europe run from 10 to 70 percent less than branded biologics.
In the U.S., however, the huge savings promised haven’t yet materialized for some biosimilars.Inflectra,for example, was originally discounted at 15 percent – a far cry from the steep discounts seen with generics, and one that may not be meaningful for most patients, Dr. Kay says.
ButRenflexislaunched at a 35 percent discount, or about $735 for a 100-milligram (mg) dose.Remicadecurrently sells for $1,200 to $1,250 per 100 mg. (Remicadeand its biosimilars are dosed based on a patient’s weight: from 3 mg to 5 mg per kilogram).
Brian Lehman, a pharmacy benefits manager for the Ohio Public Employees Retirement System and biosimilars advocate, writes that this discount may be large enough to persuade commercial insurers to preferRenflexisoverRemicade.But he thinks that increasing price competition among these drugs will likely require more biosimilars toRemicadeas well as “favorable management” by insurers.
Dr. Kay is more optimistic. “The introduction of a biosimilar that has been discounted by 35 percent compared to the originator product should foster competition, especially when another biosimilar of the same [brand-name drug] is already on the market. [That] should drive down the cost of infliximab and make it more accessible to more patients who need this effective, but expensive, biologic therapy,” he says.
Cost isn’t the only factor keeping biosimilars out of the hands of consumers, though; legal challenges are also playing a role. In addition toCyltezoandAmjevita(the two biosimilar versions ofHumira),a biosimilar version ofEnbrel(etanercept) calledErelzi(etanercept-szzs)has been tied up in court since it was approved in August 2016.
Susan Holz, director of communications for Boehringer Ingelheim Pharmaceuticals, Inc., the maker ofCyltezo, says she can’t say when her company’s biosimilar will be available to the public. “We are not able to speculate on timing but are confident in our biosimilar candidates. We will continue our efforts to make them available as therapeutic options to patients at the earliest possible time,” she says.
And although currently available to consumers, bothRenflexisandInflectraare involved in ongoing litigation withRemicade’s maker, Johnson & Johnson.
Legal maneuvering isn’t the only tactic that drug manufacturers are using to protect their drugs from their competitors. According to FiercePharma, which covers pharmaceutical industry news, exclusive contracts requiring providers to stock only a particular company’s drug, and big discounts to large hospitals and infusion centers are a couple of the methods being used by drug companies to secure their markets.
One positive: The Centers for Medicare and Medicaid Services is using a payment structure for biosimilars that’s similar to that used for generics. It’s hoped this will encourage prescribers to choose biosimilars over brand-name products.
AUTHORS: Jennifer Davis and Linda Rath for the Arthritis Foundation
Related Resources:
- What You Should Know About Biosimilars
- Arthritis Foundation Legislative Position on Biosimilar Substitution
- Arthritis Biosimilars