During this time, biosimilars have had a positive impact on the US healthcare system, hospital systems and in overall patient care, said Sandoz, which is a division of Novartis. But the company has outlined the many barriers preventing this class of medicine from being as successful in the US as it is in Europe.
To date, 28 biosimilars have been approved by the US Food and Drug Administration (FDA), the most recent being Hulio (adalimumab-fkjp) in July this year, but only around two-thirds of those approved biosimilars are now commercialized in the US, said Rob Spina, vice president, key accounts and sales, Sandoz.
He spoke to BioPharma-Reporter about the obstacles to greater adoption of biosimilars in the US market and strategies to overcome them.
What is needed is a level playing field for biosimilars and increased acceptance among physicians, payers and other stakeholders, he said. Educational initiatives will be key.
The US health system has saved US$1.1bn with the availability of Filgrastim, claimed Spina. But he reckons so much more could have been saved. A robust biosimilars market can provide significant cost savings to overburdened health systems and, with the right policies in place, can reduce patient out of pocket costs, he stressed.
“I joined Sandoz five years ago and have seen the pathway from where we went from being the first biosimilar in the market in the US to being the first to overtake the innovator in terms of market share a couple of years back, and we still hold the largest market share on that product,” he claimed.
Sandoz has four biosimilar approvals in the US, with plenty more in the pipeline, he said.
“We are definitely committed and we will be in the categories of biosimilars, insulin and others that come out in the years to come.”
This year, as well as being the five-year anniversary of the approval of Zarxio in the US, is also the tenth anniversary of the signing into law of the US Biologics Price Competition and Innovation Act (BPCIA). “Those two [events] helped paved the way for us to come to the market and while [the path] has been exciting, there are still challenges.”
In the US, there is around US$100bn to play for as biologics patents expire this year, predicted a March 2017 released report from GBI Research. “If we can all crack the uptake issue, then we can bring increased competition to the market and improved access for patients as well as bring savings to the US healthcare system.”
Reimbursement policies
But US reimbursement policies remain a barrier to growth of biosimilars in the US, said Spina.
“Current reimbursement policies in the US do not incentivize the use of a biosimilar. If a doctor wants to use or prescribe a biosimilar, they have to go and get a prior authorization from the insurance plan, and that is even if that same insurer has authorized the use for the reference biologic. So even though the same biologic matter is involved, there are extra steps needed for the use of a biosimilar, and such [associated administrative burdens] don’t help with uptake.”
The FDA has issued regulations around what biosimilars can be deemed to be interchangeable, a designation that would allow biosimilars to be exchanged for their reference products at the pharmacy level. Currently, there are no biosimilars with this designation. “The fact the FDA has rules against interchangeability, so [a biosimilar] is not like a generic where it is automatically substituted, is a challenge. From the Sandoz perspective, we think that an approved biosimilar should be interchangeable with the reference biologic.
“[Moreover], there has been a lot of lobbying and a lot of state laws that have come out that govern how biosimilars can be substituted, all of the [above] factors create constraints. It is great to see successes such as Zarxio, and others, but there is still a lot work to do in order to increase uptake in the US when you have those barriers there.”
Ensuring dissemination of accurate information
Is low awareness another barrier to expansion? Education is probably the bigger issue, according to Spina.
“There are a lot of efforts underway to disseminate misinformation, to create fears about biosimilars.
“Even though there is a ton of clinical and real-world evidence showing that patients can switch effectively and safely from a reference biological to a biosimilar, there is still doubt among clinicians and patients and they are hesitant to make those changes.
"We are encouraged, though, that agencies like the FDA have taken steps to ensure both patients and health care providers have clear and accurate information about biosimilar medicines,” he added.
Sandoz runs a lot of educational initiatives, both on its own and with other stakeholders, to inform the public about safety, efficacy and the value of the category, he added.
Collaborating to overcome hurdles to growth
As well as informing the public about the value of biosimilars, Spina said the company is also working to expand biosimilars in the US through other means:
“We are looking, in collaboration with multiple stakeholders, to try and get rid of those redundancies in prior authorization that exist with the insurers, working with agencies and others to look at Medicare Part B, to see if we could have temporary add-on payments to incentivize health care providers to prescribe biosimilars. Another area we are trying to work on is reducing or eliminating patient cost-sharing in both Medicare Part B and Part D when there is a lower cost biosimilar available over a more expensive reference biologic.”
Evidently, litigation can also slow down biosimilar market expansion efforts. Both Sandoz and Samsung Bioepis have FDA-approved Enbrel (etanercept) biosimilars but are embroiled in ongoing patent disputes with the reference product sponsor.
The future looks bright…
Bonnie Bain, global head of pharma, GlobalData, in a report released in January this year, was optimistic though about the potential for biosimilar medicines to gain a stronger foothold in the US in 2020.
The sector, she forecast, would build on the success seen with the launch of Amgen’s biosimilar monoclonal antibodies (mAbs), Mvasi (Avastin) and Kanjinti (Herceptin) in 2019.
“Even though the price differential between biosimilars and their branded counterparts is only around 15%-30%, which is significantly less than the cost savings seen with the average generic drug, we still expect that biosimilars will start to contribute cost-savings in the US in 2020.
“Uncertainty still exists for reimbursement, automatic substitution, competition from next-generation biologics and litigation but the fact that insurers such as United Healthcare placed Amgen’s biosimilar mAbs on the primary tier of its formulary bodes well for future biosimilars.”