Inside the U.S., European markets for biosimilars

While there are barriers to biosimilars’ adoption in both the U.S. and Europe, biosimilars are already producing healthcare cost savings in Europe. Similar savings are projected for the U.S. market.  

Elan RubensteinSavings to the U.S. healthcare system are projected to reach between $57 and $110 billion from 2015 through 2020, according to the IMS Institute for Healthcare Informatics. In addition, biosimilars could save the U.S. healthcare system $44 billion over the next 10 years, according to a RAND Corp study.

IMS attributes the U.S. savings to greater acceptance of biosimilar products in a growing number of therapeutic areas and an active pipeline of 56 new products in clinical development. The majority of biosimilars in development are for very profitable drugs: versions of infliximab (Remicade), etanercept (Enbrel), rituximab (Rituxin), and adalimumab (Humira).

“This robust pipeline represents an opportunity for payers to realize savings, and for physicians and patients to ensure greater access to these important treatments,” IMS Institute said.

Already, manufacturers are profiting from Zarxio (filgrastim-sndz), the first biosimilar approved by FDA in March, 2015-a drug that helps prevent infection during chemotherapy. Zarxio already has a 24% share of the market after four months. “That’s pretty impressive, compared to slower uptake in many European nations,” said Elan Rubenstein, PharmD, principal of EB Rubinstein Associates, a managed care and pharmaceuticals consultancy.

Then, in April, 2016, FDA approved Inflectra (infliximab-dyyb), the biosimilar for Remicade. Inflectra may launch in the second half of 2016, depending on resolution of the patent infringement  case of the drug.

Zarxio is priced around 15% lower than its reference product. Both current and upcoming biosimilar products are estimated to be priced between 15% to 30% lower than their reference products.

Opportunities for health systems

Eight major biologic medicines are expected to lose exclusivity protection by 2020, including treatments for autoimmune disorders and diabetes. “By opening markets to biosimilar competition, healthcare systems could realize a 30% reduction in price per treatment day compared to originator biologics,” said IMS Institute in a statement.

 “The prospect of more affordable biologic options that are safe and effective opens up opportunities for health systems to expand access to more patients, and frees up resources for investment in new areas,” said Murray Aitken, IMS Health senior vice president and executive director of the IMS Institute for Healthcare Informatics. “This also can yield significant cost savings-but not all markets are ready to fully benefit from the imminent surge of biosimilar molecules.”

In Europe, the use of erythropoietins (EPOs), granulocyte-colony stimulating factors (G-CSFs), and human growth hormone (HGH) has risen following the launch of biosimilar versions. “This increase was heavily driven by the availability of biosimilars, as well as other factors, such as expanded indications,” according to the IMS Institute statement. “In markets where access to these molecules was previously restricted, including Romania, Bulgaria, and the Czech Republic, average uptake of EPOs increased by more than 250% following the introduction of biosimilars. The greater use of biologics following the introduction of biosimilars can be attributed to their lower cost, as well as revisions to treatment guidelines that reflect improved cost effectiveness.”

Barriers to biosimilar adoption

Despite the growth of biosimilars in the U.S. and Europe, there are numerous challenges to their adoption in the U.S. These include physician willingness to prescribe them, patient acceptance of the drugs, health insurance coverage, and varying state laws.

In addition to the high costs of producing biosimilars, doctors and patients may be slow to accept the drugs as substitutes, according to an article in The Economist. Biologics must be injected, infused, or inhaled, which may discourage doctors from prescribing them, according to the article.

 “At least for the first year or two after market launch of the biosimilar, it is less likely that a patient using a reference product on a chronic basis and stabilized on that product will be switched to the biosimilar, even if there is a cost advantage to doing so. The prescriber and patient will be reluctant to chance destabilizing the clinical situation,” Rubenstein said.

However, as physicians gain more experience with biosimilars, this may become less of a concern. In addition, the concern about destabilizing a patient’s clinical condition “would not come up for a newly-diagnosed patient or for a patient who has not previously received the reference product,” Rubenstein said.

In integrated delivery networks like Barnabas Health in West Orange, NJ, all physicians in the network weigh the pros and cons when a new biosimilar becomes available. “They can speak peer-to-peer, and they come to a consensus as a peer group,” said Robert Adamson, PharmD, chief pharmacy officer, Corporate Pharmacy, for Barnabas Health, which operates numerous hospitals and clinics.

At Barnabas Health, most physicians are already prescribing  Zarxio. “In our system, we saw a fairly good uptake of Zarxio: 80% of doctors prescribed it, while 20% didn’t feel comfortable using it.” The only reason 20% didn’t use the drug is because Zarxio lacks an indication for bone marrow transplant, so doctors didn’t feel comfortable switching, according to Adamson.

However, before doctors will prescribe new biosimilars, they need assurances from the FDA that the drugs are exactly identical-as is the case with branded versus generic drugs. “Right now, FDA is just saying that the biosimilar for Remicade, for example, is ‘highly similar.’ We are all waiting for some guidance from FDA that Drug A is completely substitutable for Drug B and vice versa,” Adamson said.

Pharmacists must also be prepared to educate patients about biosimilars. Patients may ask if the biosimilar is a “generic” version of the branded drug or have heard of a less expensive generic version of the reference product.

Patients may also ask pharmacists if they can substitute what is dispensed between the biosimilar and its reference product. The answer is “no.” Pharmacists may not substitute or interchange a biosimilar that is not FDA-designated as “interchangeable” (none are as of today), Rubinstein said. In the case of a biosimilar that is interchangeable, state law may dictate what the pharmacist should do on substitution.

Biosimilars’ adoption varies by country

In the European Union, uptake of biosimilars varies by country, since payers have adopted a variety of approaches to encourage physicians to prescribe them.

“What we found most striking is how different countries can be in their utilization of biosimilars and the difference in impact that it has on the health system. Each health system has its own set of variables that determine the role that biosimilars play,” Aitken said.

For example, Germany educates physicians and implements measures designed to stimulate biosimilar prescribing, according to IMS Institute. “By contrast, Austria’s approach-where some biosimilar medicines are subject to mandatory price reductions that may force manufacturers out of the market-has had the opposite effect, resulting in reduced access to some biosimilar products,” IMS Institute said in its statement.

The European experience with biosimilars is going to be very relevant to whether the U.S. accepts certain biosimilars, according to Aitken. For example, the biosimilar to infliximab has been well established for well over a year in some European markets. “The evidence and information being gathered by European agencies will be relevant to help build confidence by physicians and patients, as well as by the U.S. FDA, around the safety and quality of the biosimilar drugs that are available.”

Adamson believes that biosimilars’ savings and acceptance will vary greatly between the U.S. and Europe. “The problem is, in the other markets, there are a lot of single-payer systems in which the price is negotiated by the government, rather than the free market, as in the U.S.,” Adamson said. “Because of that, whatever price they come up with doesn’t necessarily help in the U.S.”

In addition, with the pace of FDA’s biosimilar approvals, it will take a while for biosimilars’ savings to be realized in the U.S. “At this time, there is no biosimilar competition. You won’t be seeing price pressure until more drugs get on the market,” Adamson said.

However, even though biosimilars’ savings may not be immediately realized, no one argues that biosimilars are here to stay-and that they will have a significant impact on both the U.S. and European healthcare market and patient care well into the future.