Tony Hagen

Several trastuzumab bioimilars have been launched this year, and 6 FDA-approved adalimumab biosimilars are lined up for launch in 2023, but a cornucopia of lower-cost therapies is not looked upon by providers as favorably as might be expected. 

The reason? Payer policies make it diffi cult for providers to use the lowest-cost biosimilars available. In a webinar hosted on July 20, 2020, by 

® and The Center for Biosimilars®, a panel of experts discussed how industry dealmaking is aff ecting treatment decisions and the use of resources at the provider level.

FDA-approved biosimilars are not diff erent from reference products in any clinically meaningful way. However, for business reasons, a payer may put a particular biosimilar on formulary because of a rebate it received from the manufacturer or high-pressure sales tactics used by a rival drug producer. Often, this means that providers must use the biosimilar that the payer requires—not the lowest-cost drug. For practices that work with multiple payers, each with diff erent biosimilar preferences, this can be “a nightmare,” panelists said.

 clinical coordinator of  hematology/oncology for The University of Arizona Cancer Center in Tucson; 

chief operations offi cer for Pontchartrain Cancer Center, with locations in Covington and Hammond, Louisiana; and 

, the pharmacist evidence analyst and strategist for hematology/oncology at Kaiser Permanente, based in Oakland, California. 

 senior vice president, Clinical Communications, of MJH Life Sciences, served as moderator.

The Difficulty of Stocking Multiple Biosimilars

Stocking multiple biosimilar brands to satisfy the preferences of multiple payers is costly, and ensuring that payer preferences are followed requires the use of controls and staff  interventions that would not ordinarily be needed for treatment decisions. “There’s a lot of work by nurses, pharmacists, and fi nance people to transition to biosimilars,” McBride said.

Financial risk is possible, too, for a practice that uses the wrong biosimilar brand and cannot get reimbursed for it, said Oubre. Her practice has implemented a signoff procedure to ensure that the preferred drug is given to a patient.

“Payers are really taking an active stand in dictating the drugs we use,” she said. Payer preferences make it difficult for a medium-size practice like Pontchartrain to provide biosimilars to patients. “It presents a lot of operational challenges.”

In his ideal scenario, McBride said, payers would not decide what biosimilars could be used. The United States would follow a European-style model in which the preferred or recommended biosimilar is the lowest-cost biosimilar available. In Denmark, for example, a biosimilar company will win a tender contract to provide a biosimilar for a 12-month period, after which the bidding process will reopen.

This not only lowers costs, explained McBride, but also shortens the amount of time needed to transition a patient to a biosimilar. In the United States, the process of getting a patient set up with a biosimilar is much more complicated on many levels. “We’re constantly working to address these pieces,”

McBride said. He added that achieving biosimilar access equality, or “parity,” across drug brands is crucial to realizing the true promise of biosimilars. “I would love to see more of a European model,” he said.

“Parity would be great,” Oubre agreed. “We believe in the science of biosimilars and the cost savings, and at the end of the day we all know that term, cost toxicity, and it’s not going away.”

Kaiser Permanente is a combination payer and medical group conglomerate that has, through its leverage, been able to achieve very high levels of biosimilar uptake, specifically by singling out a single biosimilar for coverage in different classes of medicine. “Kaiser has a unique structure,” said Chiu. “We have tried to focus on 1 product; it reduces operational challenges.”

Chiu acknowledged that at the provider level there are complexities that affect whether patients can receive the lowest-cost biosimilar, but said that Kaiser Permanente has worked to overcome these issues.

However, the emphasis on a single biosimilar makes it simpler to achieve large-scale buy-in, Chiu added. There’s an education component to building confi dence among providers and patients that can be accomplished with a streamlined approach.

“There are still a lot of misconceptions about biosimilars, and people are uncomfortable about switching despite all the data,” he said.

Practices attempt to discuss biosimilar choices with payers so that restrictions can be relaxed, with varying degrees of success. McBride described “a lot of pushback” from payers, and Oubre said that in her experience, “some are more receptive, some are not.”

With regard to the education component, McBride said that biosimilar education itself has to be defi ned. This could take many forms. For example, providers and patients would benefit from more real-world information about biosimilars as well as further studies, particularly ones that would elucidate the value of switching from originator drugs to biosimilars in order to extend the benefits of therapy. “We need more data to have this discussion,” he said.

Good pharmacovigilance will be an important way to add to this critical information pool, Chiu emphasized. 

Education could include information about oncology models of care, such as Oncology Care First, the CMS successor to the Oncology Care Model, McBride said. It’s important to know how biosimilars are going to help achieve the savings that these models are supposed to achieve, he noted.

Kaiser Permanente has sought to give providers educational materials on biosimilars, which have included clinical data on individual biosimilars investigated in particular settings. This has helped to achieve “buy-in,” Chiu said.

Oubre said she has not witnessed any information on biosimilars distributed by payers, and McBride said nonbranded biosimilar information would be useful.

One group that wants more information about biosimilars is employers, Oubre pointed out. “Employers really want to know more,” she stressed. “If something goes on formulary and a patient with breast cancer is switched and gets upset, an employer doesn’t want that.” 

Tony Hagen is senior editor for The Center for Biosimilars®.

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The challenges of complying with payer mandates in biosimilars were discussed in a webinar sponsored by The American Journal of Managed Care® and The Center for Biosimilars®.

Choice Is Vital to Biosimilar Savings Picture, Panelists Say

A New Zealand study of patients with rheumatic conditions suggests that providers need to be mindful of patient attitudes toward biosimilars to prevent biased therapy choices and poor outcomes.

Patients who do online searching for medical information about biosimilars are liable to have exacerbated concerns about switching to biosimilars, according to the study, which examined patient attitudes toward these agents.  The findings also indicated that women are more likely to have concerns about switching from originator drugs to biosimilars.  

There was a positive correlation between adverse events experiences from the originator and adverse events anticipated from the biosimilar (

There was a positive association between perceptions of originator safety and the expectation that biosimilars are unsafe (

There was a significant negative association between the perceived effectiveness of the current originator and a preference for a biosimilar medicine (

Patients who research medical information online are likely to be more concerned about switching from originator products to biosimilars, according to the study.

New Zealand Study Reveals Importance of Patient Attitudes Toward Biosimilars

The year 2020 has already seen 4 biosimilar launches in the United States, and those could be augmented by several more, although the coronavirus disease 2019 (COVID-19) pandemic has introduced a wild card to the mix, said presenters at the American Academy of Managed Care Pharmacy eLearning Days 

But the pipeline from 2021 to 2025 is stocked with at least 5 approved biosimilars to adalimumab, and potentially 4 others, all of which could conceivably launch in 2023, and 14 other potential biosmilar products, which could make the next several years a very active growth time for the US biosimilar space, the presenters said.

The pace of clinical trials has also been affected, and with regard to approvals, the FDA’s most recent notice has been that there will be no “near-term” affect on these, said Leslie Fish, RPh, PharmD, who co-presented with Jeffrey Casberg, MS, RPh, in Tuesday’s session, "Drug Pipeline: Traditional Pharmaceuticals and Bisoimilars." Both are experts on the pharmaceutical pipeline with IPD Analytics.

 caused by COVID-19 in 2020 could lead to a slew of backlogged approvals or launches in 2021, Fish said.

A lot of companies have stated that they are going to slow their existing studies or hold up new studies of various agents, because they’re now working on COVID-19 therapies or vaccines, she added.

There could be multiple biosimilar agents reaching the market in the oncology space for the remainder of 2020, Fish and Casberg said. One of those drugs is HSP-130, a pegfilgrastim biosimilar that Hospira and Pfizer intend to launch against Amgen’s Neulasta originator drug. However, HSP-130, expected to launch this June, would join other biosimilars already on the market, including Ziextenzo, Udenyca, and Fulphila.

An additional drug in this class is Rolontis (eflapegrastim). The FDA accepted the application for this investigational granulocyte-colony stimulating factor analogue in December of 2019. Rolontis is under development by Hanmi Pharma and Spectrum and is targeted for an October launch.

Another biosimilar that could debut this year is a bevacizumab copy (SB8) that Samsung Bioepis and Merck hope to bring to the US market in September, according to Casberg and Fish. There are 2 bevacizumab biosimilars on the market currently, Mvasi and Zirabev, which were introduced last year. The reference product is Avastin.

There is one other bevacizumab biosimilar candidate, Bmab-100, which is under development by Biocon. This also has the potential to augment the number of biosimilar bevacizumabs available to providers, Fish said.

Lastly in the oncology class of emerging biosimilars is a rituximab biosimilar, ABP 798, the product of an Amgen/Allergan partnership, with a debut scheduled for somewhere in the fourth quarter of this year. It would go up against 2 biosimilars already launched: Truxima by Celltrion and Ruxience by Pfizer. The reference product is Rituxan by Biogen and Genentech.

“With this many biosimilars on the market, and available, there will be a decrease in costs. This decrease in cost will be seen in increasing rebates and better contracting in both the branded and biosimilar space,” Fish said.

Casberg said that eyes have been following the attempts by Sandoz to bring an etanercept biosimilar (Erelzi) to market. That issue was held up in court over patent litigation with originator manufacturer Amgen. “We’d been waiting for an Amgen versus Sandoz decision for quite a while. Turns out, Amgen prevailed, and we likely will not see an Enbrel biosimilar until 2029,” Casberg said. “There is still 1 pending court case that could change that, but odds are in favor of Amgen keeping protection for Enbrel through 2028/2029.”

There are 2 infliximab biosimilars on the market currently, Inflectra and Renflexis, and a third, Avsola (Amgen) will likely launched this year, Casberg said. Avsola was approved in December of 2019. “There are a couple other biosimilar infliximabs coming down the road,” he said. “Those won’t be available for another year or more.”

Hopes for an adalimumab biosimilar to AbbVie’s blockbuster Humira product had been on hold owing to patent litigation. Much of that legal activity has subsided, Casberg said, resulting in individual patent settlements with 9 potential competitors, each with an agreement to launch at some point in 2023. “So, 2023 will be a big year for biosimilar Humira,” he said. Of the 9 products for which settlements have been hammered out, 5 are approved by the FDA.

From 2021 to 2025, up to 14 additional biosimilars could be launched. These include biosimilars for ranibizumab, aflibercept, eculizumab, ustekinumab, cetuximab, omalizumab, botulinum toxin, natalizumab, abatacept, certolizumab pegol, darbepoetin alpha, golimumab, palivizumab, and ado-trastuzumab emtansine, Casberg said.

“There are quite a few bigger products in the works in coming years,” he said.

Novel drug approvals by the FDA have been on the uptick in recent years, Casberg noted. There were 48 last year and a record 59 in 2018. “This year with COVID-19, we’ll have to see if that impacts approvals,” he added.

thus far in 2020, 3 trastuzumab biosimilars have reached the market: Ontruzant, Herzuma, and Trazimera. Also, Pfizer launched its rituximab biosimilar, Ruxience, in January. The FDA has approved 26 biosimilars thus far, and of those,17 have been launched.

COVID-19 has affected the pace of clinical trials, and the FDA’s most recent notice has been that there will be no “near-term” affect on approvals, said Leslie Fish, RPh, PharmD, who co-presented with Jeffrey Casberg, MS, RPh, in Tuesday’s session, "Drug Pipeline: Traditional Pharmaceuticals and Bisoimilars," at AMCP eLearning Days, which replaced the annual meeting of the Academy of Managed Care Pharmacy.

More Biosimilar Launches in 2020 Seen at AMCP

Aware that travel restrictions and border controls imposed by coronavirus disease 2019 (COVID-19) pose a threat to drug supply, the International Generic and Biosimilar Medicines Association (IGBA) is working to establish priority designations for medicines in air and sea cargo transport.

The move is among diverse attempts by private and public institutions recently to secure supplies of drugs and pharmaceuticals amid the dizzying pace of events. “The situation is constantly and rapidly changing,” said Suzette Kox, secretary general of IGBA, in an interview with The Center for Biosimilars.

In recent days, many have spoken out against export curbs and other protectionist measures that threaten to upset the balance of international healthcare. Some actions by governments have involved instating emergency powers to bypass patent exclusivity protections where necessary.

Private and public institutions are trying to secure supplies of drugs and pharmaceuticals amid travel restrictions and border controls imposed by coronavirus disease 2019 (COVID-19).

Author | Tony Hagen

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