Tony Hagen is senior managing editor for The Center for Biosimilars

Tony Hagen

Investigators found inferior persistency among patients who used biosimilar vs originator forms of infliximab (Remicade) and epoetin alfa (Epogen/Procrit), although they said adherence was superior among patients on biosimilars included in the study, according to a poster presentation at AMCP 2021.

Investigators conducted a retrospective study using patient information culled from the Optum specialty pharmacy database, representing a 2-year period from January 2018 to December 2019. Investigators defined persistency as “continuation of treatment for the prescribed period” and adherence as the patient acting in accordance with prescription intervals and prescribed dosage.

The percentage of patients who remained on biosimilar infliximab dipped below 20% by the fifth prescription fill, whereas the percentage who remained on the originator product remained above 20% by at least the ninth fill, according to study authors.

The percentage who remained on epoetin alfa biosimilars dipped below 40% around the third fill, whereas patients on the originator did not dip below the 40% line until the fifth fill.

For patients treated with filgrastim and pegfilgrastim biosimilars, the persistency curves were slightly inferior to originator persistency, although these differences were not considered statistically significant. “Patients in reference drugs had higher persistence at every fill compared to biosimilars. However, significant difference in persistency was seen only between the Remicade and Epogen/Procrit groups,” the authors wrote.

However, when it came to adherence, patients in all therapy groups studied adhered better to biosimilars than reference products and had lower out-of-pocket costs if they used biosimilars, the authors wrote.

For example, adherence for patients on Inflectra and Renflexis, both biosimilars of Remicade, had 93% vs 90% adherence, respectively. The comparable figures for patients on filgrastim biosimilar (Zarxio) vs originator (Neupogen) were 81% and 60%; pegfilgrastim biosimilar (Udenyca, Fulphila) vs Neulasta, 93% vs 86%; and epoetin alfa biosimilar (Retacrit) vs originator (Epogen/Procrit), 88% vs 83%.

The largest per-fill out-of-pocket differences were seen for filgrastim biosimilars vs filgrastim originator ($102 vs $383) and pegfilgrastim biosimilars vs originator ($79 vs $376).

A higher incidence of adverse events was reported for patients on biosimilars for all groups except pegfilgrastim; however, investigators said they were unable to evaluate or categorize adverse events according to severity.

“The findings of this study reflect the positive real-world implications of utilizing biosimilars from a cost-adherence standpoint,” the authors wrote.

The data from the study were obtained from Optum and Avella Specialty Pharmacy, which was acquired by Optum in 2018. “Data collected from only 1 specialty pharmacy may not represent the general population in the United States,” investigators said.

Shah K, Lawler L. Real world evidence: impact of biosimilars on patient outcomes at a specialty pharmacy. Presented at: AMCP 2021; April 12-16, 2021. Accessed April 19, 2021. https://amcpannual2021.pathable.co/organizations/Yxzi8AFuWFPvqnPR2#/?limit=10&sortByFields[0]=isPinned&sortByFields[1]=lastActivityAt&sortByOrders[0]=-1&sortByOrders[1]=-1&uid=pAcLoMw6BXog7ypr6

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Weaker persistency and strong adherence were observed among patients taking biosimilar forms of epoetin alfa and infliximab, among others.

Study: Investigators Report Superior Adherence, Savings for Biosimilars

Editor's note: All currency figures in this story have been converted from Canadian dollars to US dollars. 

British Columbia’s public health system, PharmaCare, aims to save up to $80 million over the next 3 years by implementing the latest phase of its biosimilars switching program, which is transferring roughly 6000 patients taking the Humira originator version of adalimumab to one of 5 adalimumab biosimilars: Amgevita, Hadlima, Hulio, Hyrimoz, and Idacio.

In addition, PharmaCare will expand use of biosimilar versions of etanercept to encompass patients with plaque psoriasis currently being treated with the originator product, Enbrel.

“Biosimilars are highly similar versions of their biologic drugs, meaning they are just as safe and effective, but are a fraction of the cost,” said Adrian Dix, minister of health for British Columbia. He said the savings from the biosimilars switching program have enabled the province to expand coverage of treatments and add more drugs to formulary, making health care more affordable for residents of British Columbia.

British Columbia was the first of the Canadian provinces to implement 

 programs. The first phase was initiated in May 2019, when patients with ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and diabetes (type 1 and type 2) were switched from etanercept, infliximab, and insulin glargine reference products to biosimilars. A second phase began in September 2019, when patients with Crohn disease and ulcerative colitis were switched from reference infliximab to biosimilar versions.

The newest switch to adalimumab biosimilars will affect patients under treatment for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, hidradenitis suppurativa, moderate to severe plaque psoriasis, and psoriatic arthritis.

Since the May 2019 start, more than 90% of PharmaCare beneficiaries are on biosimilar drugs for infliximab, etanercept, and insulin glargine. The May 2019 inaugural switching phase and the second phase have involved 22,700 patients. A rituximab switching program was announced in August 2020 and was reported to involve 1600 patients.

Explaining the rationale for the mandatory switching, British Columbia officials said biologic medicines have become the “

 for public drug plans, and their costs continue to climb.” PharmaCare spent almost $75 million on Humira from December 1, 2019, to November 30, 2020. The health agency estimated that savings of 15% to 50% are available from biosimilars.

A 2020 report by the Ontario Drug Policy Research Network said that achievable annual savings from biosimilar switches could approach 

 for provincial drug plans in Canada just by switching patients from the 3 top-selling reference biologics: Humira, Enbrel, and Remicade. “A similar magnitude of savings would be available for employer-sponsored benefit plans,” the report said.

, one of the health care plan providers in British Columbia, reported generating hefty savings from biosimilar switches.

Anticipating roughly $26 million in annual savings, British Columbia's public payer PharmaCare is switching patients away from originator Humira. 

British Columbia Switches From Humira to 5 Biosimilar Versions

Using commercial and public payer data, investigators observed that payer utilization management policies such as step therapy contributed to a sizeable movement toward biosimilar use, according to a poster presentation at AMCP 2021.

“Payers equipped with proactive utilization management strategies for oncology biosimilars were able to capitalize on early utilization shifts to the less expensive biosimilar products,” the authors concluded.

They conducted a retrospective claims analysis for patients with cancer enrolled in commercial and Medicare plans between June 2019 and June 2020. They evaluated the transition to biosimilars from 3 originator products Avastin (bevacizumab), Herceptin (trastuzumab), and Rituxan (rituximab).

The authors of the study also found that, in some cases, physicians were ahead of the curve in prescribing biosimilars and switching patients from originator products to biosimilars, meaning payer coverage preferences did not force them.

Additionally, physicians in private practices were twice as likely to independently switch patients to biosimilars than their counterparts in outpatient hospitals (279 vs 131 switches, respectively, for 5374 prior authorizations).

The study also included a model of savings that could be achieved from biosimilar use based on the utilization and pricing data included. For example, use of originator bevacizumab was associated with an extra $35.6 million in spending compared with use of bevacizumab biosimilars, based on overall costs of 20,076 claims.

The comparable excess spending for trastuzumab originator was $11.7 million for 25,511 claims and $19.9 million for rituximab originator based on 9275 claims.

However, they cautioned that “true savings” could not be determined because variable rebate arrangements between payers and manufacturers made it challenging to calculate.

The study evaluated formulary policies across 16 commercial and 12 Medicaid Advantage plans, and investigators said 30% of those plans had policies that preferred biosimilars, 4% of them had non-preferred coverage, meaning originator biologics had to be used first, and 66% covered biosimilars and originators equally, or “on par.”

Biosimilar utilization actually surpassed the use of innovator brands by the first quarter of 2020 (51%), roughly half a year after the beginning of the study period.

Fowler A, Borgert R, Polson M, et al. The emergence of therapeutic oncology biosimilars: payer’s perspective. Presented at: AMCP 2021; April 12-16, 2021. Accessed April 15, 2021. https://amcpannual2021.pathable.co/organizations/AETMfk4CdeFgWTR4v

Study authors measured savings, conversions to biosimilars, and payer policies for 3 originator brands 

Study: Step Therapy Contributes to Biosimilar Utilization 

Russian pharmaceutical company Pharmapark has 

the Russian distribution rights for a bevacizumab biosimilar candidate (HD204) developed by Singapore company Prestige BioPharma.

Bevacizumab is a monoclonal antibody used in the treatment of multiple forms of cancer including metastatic colorectal cancer, advanced non–small cell lung cancer, kidney cancer, and epithelial and cervical cancers. The biosimilar references Avastin, a Roche product.

HD204 is currently undergoing a phase 3 clinical development trial (SAMSON-II) for safety and efficacy. Prestige BioPharma previously reported positive pharmacokinetic, safety, and immunogenicity results based on a phase 1 trial (SAMSON-1).

The commercialization deal encompasses distribution rights throughout Russia (aka Russian Federation), which has a population of 146 million and extends from Eastern Europe to Northern Asia. Prestige BioPharma will produce the biosimilar at its factory in Osong, Republic of Korea.

This is not the first collaboration between these 2 companies. In July 2019 they reached an agreement for the distribution of Prestige BioPharma’s trastuzumab candidate biosimilar (HD201), referencing Herceptin. HD201 is under review with the European Medicines Agency with a projected market launch in 2021.

“We are very pleased to further extend our partnership with Pharmapark to commercialize our second biosimilar program in the Russian Federation,” said Lisa S. Park, CEO of Prestige BioPharma, in a statement.

Prestige BioPharma also has an adalimumab biosimilar (PBP1502) in phase 1 development, and beyond biosimilars, the company is in early stage development of an anti–pancreatic adenocarcinoma up-regulated factor antibody (PBP1510) for pancreatic cancer and an anti–collagen triple helix repeat-containing protein antibody (PBP1710) for solid tumors.

For more about Prestige BioPharma’s commercialization plans for HD201, click 

Russia's land area is vast relative to its population, but Prestige Biopharma eyes an ample market for its bevacizumab biosimilar candidate (HD204).

Prestige BioPharma Sets Up Second Russian Distribution Deal

Two pieces of legislation with the potential to improve biosimilar uptake are headed to President Joe Biden’s desk for his signature, following approvals in the House and Senate. Biosimilars are competitors’ versions of originator drugs and generally enter the market at a discount, offering hope for savings.

 would require more robust federal efforts to educate the public about biosimilars, and the 

would impose more restrictions on what biologics and generics drugs qualify for product exclusivity protections.

Education bill cosponsor Senator Maggie Hassan, D-New Hampshire, has described biosimilars as an “under the radar alternative to expensive brand name drugs.” Hassan and cosponsor Senator Bill Cassidy, MD, R-Louisiana, say the bill is expected to help improve confidence in biosimilars and lead to increased use and savings.

The Biosimilars Forum, a trade group representing manufacturers of biosimilars, indicated it favors passage of the education legislation. “The FDA has identified education as an important factor for the successful adoption of biosimilars, recognizing the need to increase public awareness in the Biosimilars Action Plan, and increased education can empower physicians and patients,” said the group’s executive director, Meaghan Rose Smith, in a 

The Ensuring Innovation Act is designed to close loopholes that allow companies to achieve patent protections for drugs that do not represent true innovations.

For more reading on the Advancing Education on Biosimilars Act, click 

US senators hope to spread the word about biosimilars and limit product exclusivity protections to those products that truly deserve them.

Biologics Legislation Is Headed to Biden's Desk for Signature

A New York state Medicaid biosimilar preference initiative was successful in significantly boosting biosimilar use over 2019, according to a poster presentation at AMCP 2021.

For example, from the second to fourth quarters of 2019, the total percent utilization of infliximab (Remicade) biosimilars went from 59% to 78%; filgrastim (Neupogen), 87% to 94%; pegfilgrastim (Neulasta), 70% to 89%, and epoetin alfa (Epogen), 51% to 86%, investigators said.

Although they are as safe and efficacious as originator brands, and often cheaper, biosimilars in New York state cannot be automatically substituted at the pharmacy counter for originators, so provider prescriptions are required for them to be used. It was therefore necessary to bring providers on board with the biosimilar preference plan to get them to help make the conversion to biosimilar use, the investigators said.

The state Medicaid plan launched a concerted effort 6 months prior to launch of the plan to communicate with providers and share information on biosimilar equivalence to reference products. In addition, a pharmacy team reached out to providers to promote the authorization of biosimilar use among plan beneficiaries who were already receiving originator biologics.

According to the poster information provided, use of the 4 originator drugs was at or close to 100% of total utilization prior to the start of the program in the first quarter of 2019. Use of all originator brands dropped below 25% of total utilization by the fourth quarter of 2019. Conversely, biosimilar use for these 4 drug types exceeded 75% of total utilization by the end of that year.

The year-long rise in biosimilar use was steep, not gradual. Biosimilar use as a percent of total utilization exceeded 50% by the second quarter of 2019, investigators said.

“The upward trend in the utilization of the biosimilar vs reference products show that a provider-focused strategy with a phased approach was successful,” the study authors said.

Among the strategies employed to make the biosimilar promotion plan successful were not only provider outreach and communication, but also the establishment of biosimilar preferences in clinical criteria and reconfiguration of the medical and pharmacy benefit. As part of the latter, coding was adjusted to reflect biosimilar preferences and formulary documents and authorization grids were updated.

The outreach effort included communications to 1560 hematologist/oncologists, 378 rheumatologists, 1498 gastroenterologists, 823 nephrologists, and 805 dermatologists. A retrospective claims analysis was used to determine how rapidly the conversion from reference products to biosimilars occurred.

Explaining the desire to switch to lower-cost biologics, such as biosimilars, the authors wrote that although biologics are valuable for treatment of patients with complex and chronic health conditions, “these medicines come with a high cost, creating challenges for both the patient and the payer.”

Huang D, Sikder A, Banbaji F, Felton C, Patel A, Moncayo E. Conversion from the reference product to the biosimilar: experience of a New York state Medicaid plan. Presented at: AMCP 2021; April 12-16, 2021. Accessed April 14, 2021. https://amcpannual2021.pathable.co/organizations/DgLQkoXaW5MohLp7H#/?

New York Medicaid achieved 78% to 94% biosimilar utilization for 4 originator brands during a focused effort in 2019. 

New York Medicaid Ramps Up Biosimilar Use

Editor's note: For part 1 of this series, please click 

How you define biosimilar savings depends on whom you ask. The payer may be very happy with a rebate deal obtained from a biologics manufacturer that cuts costs on an originator biologic by 20%, but the patient who has to pay a higher out-of-pocket for an originator vs a biosimilar (eg, $1000 vs $500) may not be very happy with that outcome.

And yet the 20% price discount may have been secured only because of the threat of a new biosimilar entering the market.

Investigators from NORC, a University of Chicago independent research center, talked to patients, providers, group purchasing organizations (GPOs), and payers about the lack of transparency and hidden deal-making that often goes into the pricing and availability of biosimilars.

said that, for them, cost is often a factor in the decisions they make about which therapies to use. But because much of price determination is hidden in the black box, it’s hard for them to make value-based decisions consistently.

“These things are not exactly transparent, so you don’t really know if you’re saving money or not. It’s kind of a guessing game,” said a gastroenterologist who was interviewed anonymously. “I imagine that if we can get some real data and we really know what’s going on, we would make our decisions maybe a little bit more rationally.”

Study authors said that manufacturers of originator brands may negotiate deep discounts and rebates with payers and GPOs when biosimilars come to market and these may undercut the discounts offered by the biosimilar makers. Further, preestablished contracts between health plans and manufacturers may shut out biosimilar makers entirely.

“If there’s a biosimilar, we absolutely can try to…get the biosimilar on contract; and then it just depends on how the previous contract was written to inhibit us from actually being able to put [the biosimilar] on contract right away….We may have to wait until that contract expires in order to do that,” said a GPO representative who spoke to study authors.

There are signs that this lack of transparency in biologics pricing may be ebbing away. At the close of the Trump administration, CMS 

 a series of moves to force health care plans and payers to tell patients what their treatments are costing them. Starting on January 1, 2024, health plans must disclose costs of drugs, durable medical equipment, and other services; and it’s very likely that consumer advocates will exploit this information to develop industrywide comparisons, in a further snip at the veil of secrecy.

A percentage of surveyed physicians said price discounts would cause them to prescribe biosimilars over originator brands, but they said they often don’t know the real costs and they need to know that. The NORC authors said 5% of physicians would increase their biosimilar prescribing if there were a discount of under 10% and they knew about it. Higher percentages would be encouraged to do so if the discounts were greater (

Even if a biosimilar is an also-ran in the race to get on formulary, it still has a positive influence on overall pricing, the NORC study suggested. “Having the ability to buy a biosimilar does change the contracting and the negotiation strategy,” said a GPO representative whose thoughts were included in the study writeup. “I feel it puts pressure on the branded company to adjust their price points a little bit.”

However, physicians said that if contracts are still going to be awarded to the originator companies, it ought to be the case that the discounts, if there are any, should be passed along to the patients, so that they are not zapped by health plan cost-sharing requirements.

Among their recommendations for improvement, the NORC study authors suggested the following:

Stop incentivizing high list prices and, instead, encourage contracts that benefit patients and the health care system overall.

Make actual prices of drugs far more transparent for physicians and patients.

Wilde S, Schapiro L, Fletcher M, Pearson C. Understanding stakeholder perception of biosimilars. NORC. April 2021. Accessed April 13, 2021. https://www.norc.org/PDFs/Biosimilars/20210405_AV%20-%20NORC%20Biosimilars%20Final%20Report.pdf

This is the second of a 2-part series on a study from the independent research center NORC at University of Chicago concerning biosimilar acceptance and uptake.

NORC: Pricing Transparency Could Aid Biosimilar Uptake

How valuable can patient awareness be in driving the uptake of biosimilars? A recent study from NORC, a University of Chicago research center, suggested that patients are more concerned about safety and efficacy than cost when choosing drugs, although physicians will tend to prescribe lower-cost drugs and are showing signs of being increasingly confident in biosimilars. There is an inherent tension in this. 

“My doctor looking to prescribe the lowest-cost medication makes me really uncomfortable that somebody is going to cheapen what my health needs. It just makes me think that if it’s cheaper, I’m probably going to get less benefit out of it because it’s just a lower class of medication,” said a patient response that was incorporated into the NORC findings.

included a patient survey (N = 618), physician survey (N = 602), 2 focus groups with patients (N = 16), and interviews with physicians and other stakeholders, including payers and group purchasing organizations.

Biosimilars may have no “clinically meaningful differences” from the originator biologics they reference, but efforts to broadcast this message appear to be having more success with doctors than patients, according to the study.

“In terms of efficacy and safety, they’re so highly similar that it would be difficult to make a case that they’re less safe or less efficacious than the original branded molecules,” an unidentified gastroenterologist was reported as saying in the NORC study. More than 75% of providers surveyed said they believe biosimilars are as safe and effective as originator brands. And 77% of physicians said they expect to prescribe biosimilars more often over the next year.

For the most part, physicians stated that their patients did not know much about biosimilars, with 61% of providers reporting that “few or none” of their patients know that these lower-cost yet equivalent agents exist. However, of patients who were asked if they would have full confidence in accepting a biosimilar if recommended by their physician, 71% said yes, they would.

The authors of the NORC study concluded that, based on these findings, physicians’ recommendations and confidence “are the most important factors” influencing patients’ willingness to be treated with a biosimilar. “Continuing to focus resources on encouraging physician prescribing will be more important than broad scale patient education,” they wrote.

 raised at the recent Community Oncology Alliance annual meeting in which health care administrators said that biosimilars clearly have a foot in the door, but to get in much further it’s going to take a lot of long-term observation and real-world evidence. They said this is because providers want to be convinced that biosimilar equivalence demonstrated by limited studies for FDA approval doesn’t evaporate when larger, more diverse real-world populations start using these drugs.

Physicians are clearly not comfortable yet with the idea of switching patients between reference biologic and biosimilar, the NORC study suggested. “Additional data on side effects, real-world evidence about patient switches, or interchangeability designations could increase physicians’ comfort with moving established patients to biosimilars,” the authors wrote.

“I’d much prefer to start a new bio-need patient on a biosimilar agent. I have a lot of reservations trying to switch over a patient that is doing well and stable on a name-brand biologic. That is where I sort of put up a stop sign and try and avoid, if at all possible,” an unidentified dermatologist told NORC investigators.

Findings like this led the NORC investigators to conclude that rapid shifts from originator brands to biosimilars are not likely to happen, although more therapy starts on biosimilars rather than originators can be expected.

This is the first of a 2-part series on a study from the independent research center NORC at University of Chicago concerning biosimilar acceptance and uptake.

NORC: Doctors Must Overcome Patient Hesitation on Biosimilars

Biogen and Bio-Thera Solutions said they will work together to 

the tocilizumab biosimilar candidate BAT1806, which is in phase 3 clinical trials for the treatment of moderate to severe rheumatoid arthritis in adults and juveniles, systemic juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome. The proposed product references Actemra, which had 2020 global sales of $3 billion, according to Biogen and Bio-Thera.

Bio-Thera, based in Guangzhou, China, is leading the development of the biosimilar candidate, and Biogen, based in Cambridge, Massachusetts, will help market BAT1806 in all countries outside China. Terms call for an upfront payment of $30 million from Biogen contingent upon satisfactory results from the phase 3 clinical trial. Biogen will also owe commercial milestone payments and royalties, based on market penetration.

“We are excited about this new transaction with Bio-Thera Solutions, a leading commercial-stage biopharmaceutical company in China, and how BAT1806 will augment our expanding portfolio of biosimilars assets,” said Chirfi Guindo, head of Global Product Strategy and Commercialization at Biogen.

Shanghai Henlius Biotech is a relatively young company with 3 biosimilars on the market in various countries, mainly China, but it is also developing products ranging from bio-betters, which represent improvements on originator drugs, to completely novel drugs, as well as combination therapies that may involve biosimilars and originators used together.

to file a new drug application (NDA) for a checkpoint inhibitor to the National Drug Products Administration (NMPA) in China: HLX10, which the company is not billing as a biosimilar, although the drug candidate has been compared to pembrolizumab and nivolumab, for the treatment of microsatellite instability–high and mismatch repair-deficient (MSI-H/dMMR) solid tumors.

HLX10 is a programmed death (PD) inhibitor that works by interfering with the tumor cell ability to “switch off” the immune system response. The expected filing is based on successful phase 2 clinical trial results with HLX10, which Henlius intends to present at upcoming medical conferences.

Patients with MSI-H tumors tend to respond better to immune checkpoint inhibitors, and the prevalence of MSI-H across all tumor types is 14%, according to Henlius. PD-1 inhibitors for MSI-H/dMMR are approved and in use in the United States but have yet to be introduced in China, so “treatment needs are far from being met,” Henlius said. The company has obtained clinical trial approvals for HLX10 in China, the United States, the European Union, and other countries and regions.

Henlius intends to evaluate the drug candidate's safety and efficacy in 10 planned immune-oncology therapies clinical trials across a range of MSI-H solid tumor types, including lung, hepatocellular, esophageal, head and neck, and gastric cancers. The company also intends an additional NDA filing with the NMPA later this year for HLX10 in combination with chemotherapy for first-line treatment of squamous non–small cell lung cancer.

For additional news from Bio-Thera, click 

Shanghai Henlius Biotech says the market for a checkpoint inhibitor in China is wide open, and Biogen and Bio-Thera stake out a global map for their tocilizumab biosimilar.

News Roundup: Bio-Thera, Henlius Advance Biologics Development 

Providers and health care institutions are going to need a lot more real-world data on how patients respond to various biosimilars and switches between biosimilars and reference products, according to a varied panel of private practice, academic hospital, and group purchasing organization experts in a discussion at the Community Oncology Alliance virtual Community Oncology Conference 2021.

“If we can solve the issue of real-world evidence and data and supply that, I think that will support the use of biosimilars moving forward,” said Sandeep Parsad, PharmD, MBA, BCOP, assistant director of pharmacy at University of Chicago Medicine (UCM).

Providers are going to need convincing, particularly as the choices among biosimilars become more numerous, the panel said. In the oncology space, biosimilars as therapeutic drugs are fairly new, although in supportive care these have been used much longer. And it is often stated that oncologists, especially, become more circumspect in the disease setting about the choice of agents, preferring to go with a well-established originator brand that both they and the patient may have come to trust. To encourage more switching to biosimilars, more evidence is going to be the tool for that, said E. Randolph “Randy” Broun, MD, a blood and marrow transplant specialist with Oncology Hematology Care (OHC), of Cincinnati, Ohio.

“I think data are really lacking in this area. Physicians are going to want data to understand that these truly are biosimilars that are interchangeable and they’re not shortchanging their patients by doing this, even under pressure from payers,” he said.

There’s an important distinction to be made, he said. At his practice, at least, biosimilars are a concept that physicians are very familiar with and they now use these agents in many settings and are comfortable with them. But their confidence in biosimilars can be strained when multiple versions of a single reference product start to appear and they are tasked with making the right choices for their patients.

“Once we have 8 different Herceptins (trastuzumab), are they all the same? Is it reasonable to simply pull a different one off the shelf for a patient who got something different 3 months ago? That will be a barrier, I believe. And you’re only going to solve that with a lot of data that are very convincing that these things are perfectly interchangeable,” Broun said.

Cardinal Health has recognized the value in using biosimilars, as their discounts, particularly when many are available on the market, can be significant, and became proactive with its participating physician practices to cultivate an understanding of these agents that would translate into greater use, according to Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars for Cardinal Health.

Parsad said the same goes for her institution. “We took a very purposeful approach to meeting with physicians and nursing staff to talk about the regulatory requirements for approval and demonstrate how biosimilars are similar to reference products, how they have a high standard for safety and quality,” she said.

When it approves a biosimilar, the FDA certifies that it is as safe and effective as the original biologic, and that it has been rigorously evaluated, but the FDA doesn’t give it automatic interchangeable status, meaning pharmacists would be free to substitute the biosimilar with a reference product without informing the physician. Additional requirements are needed for that. It has been hard to explain to physicians that that shouldn’t stop them from prescribing biosimilars, Parsad said. “We felt that was a bit of a bump for us. This is what I’ve heard as well with other colleagues around the country, that physicians do prefer that they are informed when there is a decision whether we should switch or not from the reference product to the biosimilar. But I feel like it went fairly smoothly once there was this very open dialogue.”

It was more of a challenge to develop policies about switching from reference products to biosimilars and in what instances this should occur, she said. A lot of issues arose, such as whether patients should be asked for fresh consent before they are prescribed a biosimilar after having been on a reference product, and if a patient’s condition is stable on a reference product, is it really wise to “rock the boat” and prescribe a biosimilar? And further, following a new diagnosis of metastatic disease, should patients be started on a biosimilar instead of the reference product?

“We had to really work through this saying this is something that we believe as an organization. We believe in the literature, we believe in the data, and we would like to move forward. So, we’ve gotten past that hump,” Parsad said. 

All that said, UCM still wants to see more real-world evidence that shows biosimilars can stand the test of time outside of clinical trials performed in limited numbers of patients for the purposes of FDA approval, she said.

Oskouei agreed. “The conversation has definitely evolved with a desire for more real world evidence and studies around biosimilar to biosimilar switching. With 5 trastuzumab biosimilars on the market now for example, and more in the pipeline, this dynamic is becoming something that providers must navigate.”

At OHC, providers are now using biosimilars in practically 100% of situations when it comes to trastuzumab, rituximab, and supportive care products, such as growth factors for the control of neutropenia in patients treated with chemotherapy products, Broun said. But the practice has found it more manageable to administer a single brand of biosimilar overall except in instances where payers demand something different. “Actually, the ones that give us the most trouble as far as the payers are concerned are the growth factors. Every insurance company seems to have their favorite [pegfilgrastim], and so we stock 3 or 4 of those and we have to sort of interchange them.” 

It would be nice if payers were more lenient about the choice of biosimilars, panelists said. For example, Parsad noted that the administrative work that goes into payer authorizations could be used on something more beneficial, such as patient education and support. “We’re dealing with it as best we can, but it’s unfortunate,” she said.

These issues resemble growing pains for a relatively new option in medicine that is already proving its value, said Kathy Oubre, MS, CEO of Pontchartrain Cancer Center in Louisiana, who served as panel moderator. “The US market is still in its infancy. We just need to let it mature. Biosimilars have been, at least for our organization, a great way to help provide some cost savings to the system and to the patient.”

Next-stage biosimlar acceptance will stand on the strength and availability of real-world data as more of these biologics are launched, a Community Oncology Alliance (COA) conference panel said.