A new study suggests that a group of biosimilar drugs, which are used to treat such afflictions as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, appear as safe and effective as their more expensive brand-name counterparts, which are known as biologics. A biosimilar drug is a nearly identical variant of a biologic and is expected to provide the same result in patients.
The analysis arrives as the US health care system, which is increasingly overwhelmed by high-priced medicines, looks toward biosimilars to provide savings. In the United States, where regulators have approved just two such drugs, some estimates say prices will be 20 percent to 30 percent less than the cost of biologics.
But until more biosimilars become available, there is some debate over the extent to which physicians will become sufficiently comfortable prescribing these drugs. Biologics are made from living cells and the brand-name biotech industry, for instance, says the complex processes needed to develop biosimilar drugs may produce slight changes that can affect safety and effectiveness. The threat of lower-priced competition has prompted brand-name drug makers to petition the Food and Drug Administration to delay approvals, among other tactics.
The study authors, however, argue their findings should put some of those concerns to rest. After analyzing 19 studies, they maintain the available data indicates biosimilar drugs based on brand-name versions of anti-TNF inhibitors should be considered interchangeable. The anti-TNF inhibitors include such big sellers as Amgen’s Enbrel, AbbVie’s Humira, and Johnson & Johnson’s Remicade.
“This is the $1 billion question — are the biosimilar versions comparable? And we found, in just about every outcome examined, that the biosimilars fare very well,” said Dr. Caleb Alexander, who is codirector of the Johns Hopkins University Center for Drug Safety and Effectiveness, and one of the authors of the study, which appeared today in the Annals of Internal Medicine.
”You’ll hear arguments there is not only variation in biosimilars from manufacturer to manufacturer, but also from batch to batch,” he continued. “And this is used as a means to discourage policies that would promote adoption of biosimilars. Our study suggests this is not true and should give physicians and payers additional confidence.”
A great deal is at stake. Biologics are an increasingly large chunk of the prescription-drug market. Spending on these medicines almost doubled over the past five years, to $129 million last year, and accounted for 54 percent of the growth in prescription drug spending since 2010, according to the IMS Institute for Health Informatics, a market research firm.
Looking ahead, there are eight big-selling biologic drugs in the US with expiring patents and looming development by biosimilar rivals. Taken together, their sales are expected to exceed $200 billion by 2020, according to IMS. And this batch includes Humira and Remicade, which are also used to treat inflammatory bowel disease, as well as Enbrel.
These are all huge sellers. Last year, for instance, Enbrel generated $5 billion for Amgen, while Johnson & Johnson rang up $6.5 billion in Remicade sales, and Humira generated $8.4 billion in the US for AbbVie. Whether biosimilars yield substantial savings, however, remains to be seen. Some brand-name drug makers have been raising prices for their biologics in anticipation of the competition, prompting biosimilar makers to raise their own prices.
“I think the study makes an important contribution to understanding the issues of surrounding bioequivalence, specifically regarding anti-TNF inhibitors,” said Murray Aitken, who heads the IMS Institute. “It suggests that the biosimilarity and interchangeability of these drugs look positive, in terms of limited side effects or other complications.”
We asked the Biotechnology Innovation Organization, the industry trade group, for comment and will update you accordingly.
There is at least one caveat, however. In the FDA’s view, a biosimilar drug is highly similar to a biologic and has no clinically meaningful difference in terms of safety and effectiveness. An interchangeable biologic medicine must meet additional standards, and the agency may require additional clinical trial data to reach this threshold.
Alexander also noted that “this is just one class of medicines. We have to be cautious about inferring that other classes of biosimilars are similarly safe and effective based on this analysis. It may be they do just as well upon examination, but we didn’t examine those. So our analysis shouldn’t be used to infer too much about [the] broader world of biologics.”
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Great write up. STAT has been reliable and informative tool for me as a medical professional and a small-time investor.
Hi Ed. I’m going to quibble with the title of your article, ‘Some biosimilars are just as good as some pricey biologics’, because the Annals of Internal Medicine analysis was about TNFs in particular and because the title implies that some biosimilars aren’t ‘as good as’ their reference products. In Europe, biosimilars have been around since 2006: Those biosimilars the EMA allows onto the market – based on a review to demonstrate biosimilarity – are ‘just as good as’ the reference products. In the USA, the FDA will approve biosimilars only if manufacturers document biosimilarity to their reference product. There is one report of an erythropoietin biosimilar in Europe that resulted in deaths, due to something that leached out of the vial’s stopper, evidently. Other than that, I haven’t heard of quality problems for regulator-approved biosimilar. That doesn’t mean to get complacent: Payers are concerned about biosimilar quality, and the public isn’t convinced of biosimilar quality – so I expect that biosimilars on the market will be tracked by their NDC (may be a problem for medical benefit drugs that are often billed by HCPCS JCodes, unless NDCs are required as well on the claim). Big issues with biosimilars are: 1) is the supply reliable, to avoid stockouts? 2) will manufacturers support the product (generic manufacturers don’t offer much support)? 3) how will manufacturers differentiate their biosimilars to decisionmakers, since they are unlike interchangeable small molecule generics? 4) will decisionmakers and patients accept and even incentivize use of biosimilars (as CVSCaremark recently announced with re Zarzio in place of Neupogen, for next year’s drug formulary), and under what circumstances? 5) how to avoid a ‘race to the bottom’ on price, which is what has resulted in shortages of generic cancer injectables. If it’s a race to the bottom on price, why would big-name manufacturers – like Pfizer, Amgen, Novartis – continue to play? But that probably won’t happen – just like a race to the bottom is not happening in Europe. Infliximab biosimilar discount of almost 70% in Norway has won that product ~55% market share (as of year end 2015). But is that pricing – if available in major markets worldwide, not only in a small market like Norway – sustainable from a manufacturer profitability standpoint? I don’t know the answer. But it’s got to be that to support a viable biosimilars market. Elan
Ed, Dr Rubinstein makes excellent points although in not sure if the payers lose more sleep over quality than price. To avoid potential shortages FDA should require a minimum of two year stability studies and a defined restocking program. One thing I’m fairly sure of: once the race to the bottom is achieved the pharmaceutical industry will be essentially 100% genericized as there are no real cash cows in development to sustain profitability in the long run. We will see an acceleration of merger activity and massive restructuring as the industry becomes fully commoditized. Pharma will devolve into a battle of white shoe lawyers trying to protect patents on mature products.
To your other point, the FDA has deemed that an approved biosimilar is interchangeable with the originator, so it may not matter how “good” the biosimilar is compared to the pricey originator. This will give the PBMs all the cover they need to make the biosimilars 100% therapeutically substitutable.
Some of your arguments are good. But the ones concerning “A race to the bottom” are not. If the bottom falls out of biolsimilar pricing once they are available (something not actually seen, incidentally–prices have fallen, but not to trivial levels), the major drug discovery companies are NOT going to choose “not to play”. They still make billions while covered under patent. It only means that a patent cliff of some sort starts to appear for biologics side–just as it has for small molecules. The companies who do discovery won’t like that as much, but the billions they can make before drugs go off patent are assuredly sufficient to keep them in the game.
If there are already generic versions of drugs that lower prices, then what is the advantage of biosimilars?? They need to be labeled, just as GMO foods should be labeled…
Perhaps biosimilars should also have the approval of the USDA?? But there is another sleepy govt watchdog that lets consumers be guinea pigs…
I think you mean the Humane Society since some of these processes use mouse monoclonal antibodies.
I don’t think you understand the difference between generics and biosimilars.
Generics are copies of the more traditional types of medicines we are used to i.e. pills and tablets – all of which are chemical products. Science enables copies of these medicines to made with 100% accuracy.
Biosimilars are copies of biological medicines. Biological medicines are made from living biological cells and cannot be exactly copied. The closest the copyist came come to is a highly similar medicine, but it is not the same. And whatever differences exist could have an impact on the body. hence, biosimilars are regulated very heavily and the clinical development that is needed in order to gain FDA approval is far more extensive than it is for a generic medicines. The cost and difficulty of developing biosimilars is such that there are not so many companies that can produce these medicines. They are completely and utterly different to generics.
Abbott is in like flint. They have justified their $500/hour lawyers by securing 70 additional manufacturing patents that will ensure that biosimilars are kept at bay until at least 2022. Considering that the price has risen 400% since its approval, by 2022 the cost will be a tad shy of $100,000/yr. Then again there is good old methotrexate at $25/month as long as you can manage to avoid pulmonary fibrosis.
http://www.wsj.com/articles/patent-office-to-review-a-regimen-of-abbvies-humira-1463501372