Skylar Jeremias

Two posters presented at the annual conference of the American Academy of Ophthalmology (AAO) demonstrated positive phase 3 results for proposed biosimilars that reference blockbuster drug, Eylea (aflibercept).

The first poster showed an evaluation of the safety, efficacy, and immunogenicity of SB15, an aflibercept candidate developed by Samsung Bioepis, over the course of 32 weeks in patients with neovascular age-related macular degeneration (nAMD).

In total, 449 patients with treatment-naive nAMD were included and were randomized 1:1 to receive intravitreal injection of 2 mg of the biosimilar (n = 224) or the reference product (n = 225) for 48 weeks. At week 32, the patients in the reference product group were randomized 1:1 again to either stay on the reference product or switch to the biosimilar.

The primary end point was change from baseline in best corrected visual acuity (BCVA) at week 8. The secondary end points were the change in BCVA at week 32 and change from baseline in central subfield thickness at week 32. Overall, 97.6% completed week 32 of the study.

Equivalence was met for the primary end points, and no new safety signals were identified. The incidence and severity of treatment-evident adverse events (TEAEs) between the 2 products were similar up to week 32. Immunogenicity and pharmacokinetic (PK) profiles were similar between treatment arms.

“We hope that our continued efforts for data generation help ophthalmologists have better understanding of biosimilars, and their comparable efficacy, safety, immunogenicity, and PK profile to reference products,” said Jin Ah Jung, director and medical affairs group leader, Samsung Bioepis, in a 

The final results from the study up to week 56 will be presented in the “near future” for additional long-term data on the comparable safety and efficacy of SB15 and the reference product.

The second study looked at the patient outcomes of MYL-1701P, a biosimilar candidate developed by Momenta Pharmaceuticals and Viatris, a company developed through a merger between Mylan Pharmaceuticals and Upjoin.

INSIGHT aimed to assess the therapeutic equivalence between the biosimilar and the US and EU versions of the reference product in patients with diabetic macular edema. The primary end point was mean change in BCVA at week 8. Safety, tolerability, and immunogenicity were evaluated over 52 weeks of treatment.

The study population included 355 patients from 9 countries who were randomized 1:1 to receive the biosimilar (n = 179) or reference product (n = 176). The study produced an adjusted treatment difference of 0.04 letters (90% CI, –1.16 to 1.24) for the groups, showing therapeutic equivalence between the drugs.

TEAEs were comparable for the biosimilar and reference product groups (n = 138 vs 138). No meaningful differences regarding antidrug antibodies were observed. The authors concluded that the proportion of patients who had meaningful gains and losses in visual acuity were similar between the treatment arms and that the biosimilar was safe and well tolerated by patients.

 that Biocon Biologics would take over Viatris’ entire biosimilar business.

1. Woo SJ, Sadda SR, Bradvica M, et al. SB15, a proposed biosimilar to aflibercept, in nAMD: 32-week results. Presented at: AAO 2022; September 30-October 3, 2022; Chicago, Illinois. Poster PO381.

2. Bressler SB, Barve A, Beckmann K, et al. MYL-1701P (proposed biosimilar aflibercept) compared to Eylea in DME: outcomes from the phase 3 INSIGHT study. Presented at: AAO 2022; September 30-October 3, 2022; Chicago, Illinois. Poster PO387.

Articles

Positive Results for Aflibercept Biosimilars Seen at AAO 2022

How has the economic value of oncology biosimilars changed over time and how do the economic benefits differ between stakeholders?

I think the economic values continue to grow. We've seen from our European colleagues that they've been able to uptake these medications sooner and really reduce cost. And I think that's what a lot of us are interested in—how do we preserve efficacy and reduce cost? So, I think the economic benefits can continue to grow.

But it is different depending on the different stakeholder. So, from our payer colleagues, they are looking at rebating and getting the total cost of care down on their end by larger rebates and preferencing therapy. Whereas, on the hospital side, we're also looking at uptake of biosimilars to reduce the cost of care and still provide efficacious options. I think it's going to be interesting, though, in the future as more agents come forward, and the rebating continues, and how does that degrade the average sales price for the health systems, where it still provides economic value, and it'll be more interesting of how it impacts reimbursement moving forward.

What utilization trends have you observed and what are your predictions for how the oncology biosimilar space will evolve going forward?

Utilization is continuing to grow. I think that's something that we're excited about. And as we see more therapies come into the market, I think people are starting to recognize that having an adoption strategy is important. I think with that adoption strategy, people are becoming smarter in the way that they're building out their electronic medical records, deciding to designate policies in order to provide a better uptake and faster uptake. And I think at the same time, as payer colleagues are to preference biosimilars, we see it to grow. So, that being said, I know we have a lot of market approvals coming up in the next few years. I personally am really excited, and I think this will, in turn, create larger utilization and cost savings across the country and actually reduce the amount of spend in the US directly related to biosimilars.

Videos

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, explains how stakeholders may view the economic value of biosimilars differently based on their goals and his predictions for how biosimilar utilization will develop in the future.

Dr Ryan Haumschild Compares Viewpoints on Biosimilar Value Between Stakeholders

This episode is going to take a look at some of the big stories regarding oncology biosimilars throughout the month of September, including 2 FDA approvals, and the withdrawal of a European application.

FDA Approves Stimufend, the US’ Sixth Pegfilgrastim Biosimilar

https://www.centerforbiosimilars.com/view/fda-approves-stimufend-the-us-sixth-pegfilgrastim-biosimilar

FDA Approves Celltrion Biosimilar for Avastin, Vegzelma

https://www.centerforbiosimilars.com/view/fda-approves-celltrion-biosimilar-for-avastin-vegzelma

Oncology, Ophthalmology Biosimilars Progress in Europe

https://www.centerforbiosimilars.com/view/oncology-ophthalmology-biosimilars-progress-in-europe

Biosimilars Check-In: Canada Approves Third Etanercept; Prestige Withdraws Trastuzumab Application

https://www.centerforbiosimilars.com/view/biosimilars-check-in-canada-approves-third-etanercept-prestige-withdraws-trastuzumab-application

Coherus Rep Shares Competition Strategy for Adalimumab, Pegfilgrastim Biosimilars

https://www.centerforbiosimilars.com/view/coherus-rep-previews-interchangeable-ranibizumab-adalimumb-launches-on-pro-competitor?seriesVid=5

Policy Harmonization, Clarification Could Aid Biosimilar Uptake Efforts

https://www.centerforbiosimilars.com/view/policy-harmonization-clarification-could-aid-biosimilar-uptake-efforts

Upcoming WHO Guideline Changes May Reduce Data Requirements for Biosimilar Development

https://www.centerforbiosimilars.com/view/upcoming-who-guideline-changes-may-reduce-data-requirements-for-biosimilar-development

Dr Ivo Abraham Column: When More May Yield Less—Price Erosion of Biosimilars Following US Market Entry

https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-when-more-may-yield-less-price-erosion-of-biosimilars-following-us-market-entry

Podcasts

On this episode of Not So Different, we take a look at some of the big stories regarding oncology biosimilars throughout the month of September, including 2 FDA approvals, and the withdrawal of a European application.

Biosimilars Oncology Roundup for September 2022—Podcast Edition

 preparing for the 2023 introduction of adalimumab biosimilars, September featured a number of updates for oncology biosimilars, including 2 FDA approvals and the withdrawal of a European application.

At the beginning of the month, the FDA approved Fresenius Kabi’s pegfilgrastim biosimilar referencing Neulasta, 

 (pegfilgrastim-fpgk). The approval marked the sixth pegfilgrastim biosimilar to be approved in the United States. When launched, Stimufend will be used to treat patients with cancer undergoing chemotherapy who are at a high risk of febrile neutropenia

Towards the end of the month, the FDA approved another oncology biosimilar, Celltrion Healthcare’s 

, which references Avastin (bevacizumab). It is the fourth bevacizumab biosimilar to receive FDA approval and will be used to treat several types of cancer.

In addition to the FDA approvals, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency also 

. The approval marked the third oncology biosimilar developed by Celltrion to be approved by the regulator, and the news came less than a month after the European Commission granted Vegzelma marketing authorization.

 its marketing authorization application for its trastuzumab biosimilar (Tuznue) that it submitted to the European Medicines Agency. The company cited the negative opinion from the Committee for Medicinal Products for Human Use and the results of its re-examination period as reasons and said that it plans to submit a new application at the end of 2022.

® interviewed Paul Reider, chief commercial officer at Coherus Biosciences, about its current pegfilgrastim biosimilar (Udenyca) and its soon-to-be marketed products (Cyltezo, adalimumab biosimilar; Cimerli, ranibizumab biosimilar). During the interview, Reider previewed the upcoming filing and potential launch of Coherus’ 

Speakers at the DIA Biosimilars Conference concluded that 

 across regulatory agencies regarding biosimilar policies could help promote biosimilar uptake. The speakers pointed out the definition discrepancies and concerns about evidence that switching between reference products and biosimilars is safe for patients and offered suggestions for what agencies could do to instill confidence in biosimilars.

 found that analytical and in-vitro functional studies along with pharmacokinetic and pharmacodynamic evaluation studies may not be useful for evaluating the efficacy of biosimilars. The review provided recommendations for the World Health Organization (WHO) Expert Committee on Biological Standardization in preparation for its planned revision of WHO guidelines.

The authors of the review called for the new guidelines to clarify quality measurements, establish a stepwise progression to reduce the need for in vivo nonclinical tests, and reduce the requirement for confirmatory efficacy and safety studies.

A column from Ivo Abraham, PhD, dove into how drug prices resulting from biosimilar competition has changed since the introduction of filgrastim biosimilars and factors that could contribute the most to 

. Abraham chronicled the pricing trends associated with the introduction of biosimilars for Neulasta, Neupogen (filgrastim), Rituxan (rituximab), Herceptin (trastuzumab), and Avastin.

In addition to our month-long series preparing for the 2023 introduction of adalimumab biosimilars, September featured a number of updates for oncology biosimilars, including 2 FDA approvals and the withdrawal of a European application.

Biosimilars Oncology Roundup: September 2022

The FDA approved Celltrion Healthcare’s Vegzelma (bevacizumab-adcd; CT-P16), a biosimilar referencing Genentech’s Avastin. The approval marks the fourth bevacizumab biosmilar to be approved in the United States.

Additionally, Vegzelma is the second bevacizumab product, the fifth oncology biosimilar, and sixth biosimilar overall to be 

 (pegfilgrastim-fpgk) was approved in September 2022, 

 (ranibizumab-eqrn) was approved in August, 

 (pegfilgrastim-pbbk) was approved in June, 

 (bevacizumab-maly) was approved in April, and 

 (filgrastim-ayow) was approved in March.

Recurrent or metastatic nonsquamous non–small cell lung cancer

Persistent, recurrent, or metastatic cervical cancer

Epithelial ovarian, fallopian tube, or primary peritoneal cancer

“Biosimilars have been used in many disease areas including oncology, and have shown to be safe and effective while lowering the drug cost and increasing the access to more patients around the world….With the availability of biosimilars such as Vegzelma in the U.S., oncologists will have additional treatment options for patients across multiple cancer types,”  Claire Verschraegen, MD, MS, FACP, director of the Division of Medical Oncology at the Ohio State University Comprehensive Cancer Center, said in a 

Vegzelma marks the third Celltrion-developed biosimilar to receive FDA authorization, following the approvals of 

(trastuzumab-pkrb) in December 2018. Both Truxima and Herzuma are a part of a commercialization agreement between Celltrion Healthcare and Teva Pharmaceuticals, in which Teva will be responsible for US marketing.

Celltrion noted that Vegzelma was also available in the European Union in August 2022 and in the 

“The approval of Vegzelma is an important milestone in the U.S. which adds to our growing portfolio of oncology treatments and marks an important step forward in expanding access to cancer care…," commented Jaeik Shim, chief operating officer at Celltrion USA. "We look forward to working with payers and providers to make our product available to patients. With our high-quality and affordable biosimilar medicines, we plan to strengthen our presence in the U.S. and contribute to a more sustainable healthcare system for the future."

Vegzelma became the fourth biosimilar referencing Avastin (bevacizumab) to be approved for use in the United States for several types of cancer.

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of September 26, 2022.

 across regulatory agencies and developing a better understanding of how different stakeholders approach biosimilars could help get more patients and providers on board with using biosimilars, according to panelists at the DIA Biosimilars Conference.

Number 4: Panelists at the DIA Biosimilars Conference discussed how biosimilars can help 

 and why patient notification for switching to biosimilars must be handled with caution.

Number 3: In a review article discussing the 

 in neovascular retinal diseases, the authors concluded that biologics have significantly improved patient outcomes, noting that vascular endothelial growth factor inhibitors are now considered first-line treatments.

Number 2: The final part of a 4-part series assessed what 

 about the US introduction of adalimumab biosimilars coming in 2023 as well as policy considerations they can implement to reap the benefits of biosimilar savings.

Number 1: Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, chronicled how drug prices as a result of biosimilar competition has evolved over time and what factors may contribute the most to 

To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of September 26

Outside of the United States, 2 companies shared news regarding the progress, or lack thereof, of their respective biosimilars, with 1 announcing an approval and another experiencing a setback.

Canadian Approval of Etanercept Biosimilar

Health Canada has approved Rymti, an etanercept biosimilar developed by Lupin Limited, for use in patients with rheumatic conditions across Canada. The 

 from Lupin Limited marked the third biosimilar referencing blockbuster drug Enbrel to be approved in the country.

Etanercept is an injectable tumor necrosis factor inhibitor used in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and plaque psoriasis in adults and children.

“Lupin is committed to enhancing patient access to high-quality, life-enhancing biosimilars…. The approval for Rymti in Canada is a key milestone in our endeavors to improving access to medicines. It underscores the scientific success of Lupin’s biosimilar programs and our commitment to advancing healthcare through innovation,” said Cyrus Karkaria, PhD, president of Lupin Limited’s biotech division.

Rymti follows in the footsteps of Brenzys and Erelzi, which were 

 in August 2016 and April 2017, respectively. Additionally, there are 3 etanercept biosimilars approved in the European Union, 2 in the United States, and 5 in Brazil.

Prestige Biopharma Pulls European Application for Tuznue

Singapore-based Prestige Biopharma announced that it has 

 for marketing authorization for its trastuzumab biosimilar (Tuznue; HD201) that was submitted to the European Medicines Agency.

In May 2022, Prestige asked for their marketing authorization application (MAA) to be re-examined for Tuznue after it received a negative opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Despite its clinical trial data showing comparability and biosimilarity between the biosimilar and reference product (Herceptin), the CHMP gave a negative opinion because there was “disparity in the range of acceptance for the criteria of analytical comparability between the clinical testing batch and commercial production batch of HD201.”

During the re-examination period, a newly assigned main rapporteur gave a positive opinion but it could not overturn the CHMP’s range of acceptance for the analytical comparability criteria. Prestige voluntarily withdrew its MAA and said that it plans to reapply to EMA with supplemented data through more clinical testing and analysis to meet CHMP’s criteria.

Currently, applications for HD201 are under review by Health Canada and the Korea Ministry of Food and Drug Safety. Prestige said that plans to submit a biologics license application for the biosimilar to the FDA by the end of 2022.

Trastuzumab is used in the treatment of human epidermal growth factor 2-positive breast cancer and metastatic gastric cancer. As of September 2022, 

 6 EMA-authorized trastuzumab biosimilars (Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera, Zercepac).

Prestige’s internal and external expert advisory board panel commented, “The company’s confidence is based on the excellent pharmaceutical quality of HD201 proven through clinical studies and multiple analysis. Through the re-examination, we received positive opinion by the main rapporteur, which is encouraging. We will do our best to obtain approval for HD201 in US and Europe without any doubt and provide patients with better access to treatments.”

Health Canada approved Lupin Limited’s Rymti, the third etanercept biosimilar to be granted regulatory approval in the country. Meanwhile, Prestige Biopharma announced that it withdrew its European application for its trastuzumab biosimilar.

Coherus Rep Predicts How the Ophthalmology Biosimilars Space Will Develop

Coherus Rep Explains What Interchangeability Means in Ophthalmology vs Rheumatology

Coherus Rep Discusses Why Coherus Sought Interchangeability for Cimerli

Coherus Rep Previews the US Market Introduction of Adalimumab Biosimilars

Part 5 available now! 

Paul Reider, MBA, chief commercial officer at Coherus Biosciences, chronicles why Coherus got an interchangeable designation for its ophthalmology biosimilar, how it plans to set its adalimumab biosimilar apart from the rest, and when the pegfilgrastim market could see a competitor for Neulasta Onpro.

Coherus Rep Discusses Interchangeable Ophthalmology Biosimilar, Previews Onpro Competitor

The US biologics industry is about to face its biggest challenge yet: the introduction of between 7 and 10 adalimumab biosimilars throughout 2023, ending market exclusivity for Humira (reference adalimumab), the most profitable biologic drug in the world.

In 2021, Humira generated $20.7 billion in sales, making it the second most-sold drug on the global market that year, topped only by Pfizer’s COVID-19 vaccine. Humira is also ranked number 2 on the list of the 

 drugs of all time. Biosimilars create a new opportunity for payers to save a lot of money. Overall, projections show that adalimumab biosimilars could generate 

 in savings by 2025, a 50% share of the total amount of saving expected from all biosimilars between 2021 and 2025.

Payers are likely to see the greatest financial benefits from adalimumab biosimilars. They are also likely to be at the forefront of decision-making around biosimilars, as they will oversee formulary lists and manage policies, such as step therapy and prior authorization requirements, that impact whether patients will have access to adalimumab biosimilars.

This month, The Center for Biosimilars® has examined all aspects of what the launch of adalimumab biosimilars in the US market will mean for stakeholders, from lessons learned in other markets to the need to hear from providers who must decide whether to prescribe new products.

This final installment in a 4-part series will dive into the pros and cons of certain payer policies and their effects on the potential for biosimilars savings as well as how payers can prepare for the launch of adalimumab biosimilars.

According to Vizient’s 2022 Pharmacy Market Outlook report, when adalimumab biosimilars arrive in the US market, payers will structure formulary lists using 

: preferring Humira, preferring at least 1 biosimilar, or covering the biosimilar(s) and reference product at parity.

Some industry experts have called for a parity approach, which could allow for providers to pick the 

 for their patients based on price, availability, and patient preference. Others have argued that preferring biosimilars is the best way to ensure biosimilar utilization and savings for all stakeholders.

Regardless of which strategy would be best for instilling market competition and generating savings, either may be more economically beneficial than prioritizing the reference product. According to a 2020 survey from the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, US health plans granted preferred status to biosimilars in 

 of coverage decisions. Additionally, in rheumatology, 65% and 59% preferred reference infliximab (Remicade) over biosimilars Renflexis and Inflectra, respectively.

However, a report from the HHS Office of Inspector General found that Medicare Part D plans alone missed out on between 

 in savings during 2019 by prioritizing reference products over biosimilars. Additionally, Health New England, a nonprofit payer in Massachusetts, saved 

 in a single year by reaching 93% utilization of infliximab biosimilars.

To achieve full benefits, payers are encouraged to evaluate which strategy is best for their organization, taking into account the needs of their practices and beneficiaries. Payers should also work with their pharmacy benefit managers (PBMs) to advocate for biosimilars. In some cases, payers may need to 

 with current PBMs and form relationships with new ones to ensure that biosimilars can save payers money—and that employers don’t switch to another payer.

Payers may wish to re-examine formulary tiers and other savings programs to promote biosimilars. In 2021, 

 recommended that payers such as Medicare Part D plans should include a dedicated specialty tier for generics and biosimilars, increase add-on payments to providers who use biosimilars (average sales price plus 8% vs 6%), and create a 

 program to encourage biosimilar adoption.

Additionally, payers should keep in mind that if they restrict access to biosimilars and biosimilar savings, policymakers, such as the 

, may introduce legislation to override payer preferences by requiring coverage for all biosimilars.

Another consideration for formulary placement will be interchangeability status. Up to 5 adalimumab biosimilars are expected to have an interchangeability designation. The United States doesn’t have much experience with interchangeable biosimilars as 

 is will be on the market until October. Until these biosimilars launch, the launch prices as well as their discounts compared to Humira will remain unknown.

Payers may want to consider not restricting formulary placement to adalimumab biosimilars with interchangeability as it may limit competition in the market, which will impact adoption rates, potentially giving rise to 

 about what interchangeability designations mean. 

Interchangeable biosimilars are neither safer nor more effective than noninterchangeable biosimilars. 

Interchangeability only impacts the ease to which pharmacists can distribute certain biosimilars to patients. Prioritizing interchangeable adalimumab biosimilars over other adalimumab biosimilars could limit savings for payers as well as the rest of the health care system.

In addition, payers should remember that most adalimumab biosimilars will not launch until the second half of 2023. In January 2023, only 1 biosimilar to Humira will be available (Amjevita). Up to 9 others are expected to launch in July 2023, with some high-concentration options expected to launch in 2024 and beyond. Payers who wish to add adalimumab biosimilars to formulary and want to generate the most savings possible should ensure that their formulary modification policies are updated so that biosimilars can be added as soon as they enter the market.

Rebates and reimbursements are known to influence prescription habits, formulary placement, and prevent biosimilar dissemination to patients. Both structures tend to incentivize the use of reference products. However, payers may want to look into ensuring that rebates and reimbursements encourage biosimilar use to ensure that better savings and clinical outcomes can be achieved.

Over the past few years, more payers have been adjusting their reimbursement strategies to incentivize biosimilar prescriptions, according to a report from Magellan Rx Management. The report found that most payers indicated that biosimilar pricing was the 

 on their reimbursement decisions, and provider willingness to switch patients from a reference product to a biosimilar was cited as the next most impactful factor.

 rebates and reimbursement agreements with their PBMs and practices, respectively, to ensure that lower-cost biosimilars are accessible to beneficiaries and result in cost savings for everyone.

Payers should also keep in mind that short-term benefits from rebates could prevent 

 from biosimilars, thus diminishing incentives for businesses to invest in future biosimilars, limiting market competition that could drive down prices and lead to further lost savings for payers.

Obviously, payers will do what is best for business, and it may be tough to convince many to take a chance on adalimumab biosimilars, especially if rebates for Humira prevent payers from adding adalimumab biosimilars on formulary lists. However, several health systems have been able to generate significant savings from adopting policies that enable biosimilars to be added to formulary:

Pharmacare, a public payer in a Canadian province, anticipates savings will reach about 

 (about $61 million USD) by 2024 after it added 5 adalimumab biosimilars to formulary in 2021

Additionally, the Biosimilars Forum has a 

 that quantifies the amount that states could save if biosimilars accounted for 75% market share.

Reframing Prior Authorization and Step Therapy

Prior authorization and step therapy policies can aid payers by giving them and PBMs more of a say in which medications are prescribed to patients, especially if those medications have higher rebates. Both presenting challenges to biosimilars and preventing providers from being able to give them to patients.

In addition to presenting another barrier to biosimilar utilization, prior authorization policies create undue administrative burden on payers and practices. In a survey from the American Medical Association, providers reported that they have to wait between 

 to receive a decision on prior authorization requests from payers, forcing patients to wait longer periods of time to receive their medications.

A big concern providers have is that prior authorization, in a way, 

 by requiring practices to ask permission to prescribe their patients a medication, according to a panel discussion on prior authorization at the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit. One panelist argued that using prior authorization for formulary management is inappropriate because it puts extra burden on practices to stock more biologics than could be easily managed and requires nurses to keep track of more formularies, making it more difficult for practices to manage costs related to biosimilars.

Payers should evaluate whether prior authorization requirements for adalimumab biosimilars will reduce efficiency within health systems and the amount of biosimilar savings payers could receive.

Step therapy policies in which patients will be required to try the reference product before a biosimilar can 

 in ways they may not anticipate. An analysis from Avalere found that patients who were forced to start therapy with a reference product and experienced negative outcomes were likely to max out their deductible and copay requirements as soon as 5 months into a plan year, leaving payers to pay for the patients’ new medication for the next 7 months. However, patients with no step therapy requirements likely would not hit the maximum out-of-pocket costs until the end of the 12-month period.

Additionally, payer costs were 37% higher in cases where patients underwent step therapy with a negative outcome, costing them an average $50,000 more monthly. The impact that step therapy could have on adalimumab biosimilar use, and subsequently payer costs, is likely to be even more dramatic considering that Humira is one of the most expensive and top-selling drugs in the world.

However, step therapy policies that require patients to 

 before switching to a more expensive product could help foster savings for payers. 

 from Magellan Rx Management found that giving payers the option to use step therapy that promotes biosimilars or parity reimbursement helped the PBM achieve a 90% utilization rate of oncology biosimilars over a 1-year period, showing that these policies on their own can boost adoption rates and cut costs.

Payers should consider whether step therapy requirements benefit them and their beneficiaries. Payers with requirements favoring reference products may want to change them to favor biosimilars instead or they may want to do away with them altogether. They should take an individual approach to evaluate which outcome would generate the most savings for them, especially as over 7 adalimumab biosimilars are expected to enter the market at potentially significant discounts to Humira.

What Providers, Patients, Pharmacists Want

Providers, pharmacists, and patients are all asking for better access to biosimilars. Biosimilars offer the entire health care system, not just payers, the opportunity to save money on expensive biologics, including Humira.

They are asking for more options, easier access, 

. Many providers have indicated that they’ll 

 biosimilars, and many patients will be seeking a high-concentration formulation, especially those who are already using high-concentration Humira, which accounts for 

Many clinicians are looking to have better communication with payers and are looking for payers to provide 

 on drug pricing, formulary placement, and point-of-care information on cost savings.

One indication that providers and beneficiaries want biosimilar access is 

, which allow reference products to be substituted for a biosimilar regardless of interchangeability status. Some practices may implement automatic substitution policies to make switching patients to biosimilars easier and cut costs. While these policies will not get around prior authorization requirements, these policies could be viewed as a sign that providers and patients are willing to take action to ensure biosimilar use and lower drug costs.

Payers should also keep an eye on the growing cries for Congress and government agencies to step in and create frameworks that safeguard access to biosimilars. 

 on Congressional leaders to make drug coverage more affordable for American workers. The American College of Physicians have urged policy makers to reform the regulatory and market systems to 

 to biosimilars. A group of 16 advocacy groups called for HHS to make 

 for all biologics as part of a drug price reform program. Also, the Federal Trade Commission is 

 and their impact on formulary decisions and patient outcomes.

Payers have much at stake in the adalimumab game and have a lot of power to change things to make biosimilars accessible, affect market dynamics, and generate savings across the health care industry. But the question remains, will they take a chance on adalimumab biosimilars, thus playing a massive part in how the market will develop, or will they choose to sit back and let the potential savings pass by?

Arad N, Staton E, Lopez MH, et al. Realizing the benefits of biosimilars: biosimilars and rebate walls. Duke Margolis Center for Health Policy. Published March 2022. Accessed August 31, 2022. 

https://healthpolicy.duke.edu/sites/default/files/2022-03/Biosimilars%20-%20Overcoming%20Rebate%20Walls.pdf

The final part of this 4-part series assesses what payers should know about the US introduction of adalimumab biosimilars coming in 2023 as well as policy consideration they can implement to reap the benefits of biosimilar savings.

Part 4: How Payers Can Prepare for Adalimumab Biosimilars

Starting in January next year, the United States will welcome up to 10 adalimumab biosimilars referencing Humira, one of the most profitable drug in the world. Currently, there are several barriers to uptake to biosimilars, including payer and pharmacy benefit manager interference with formulary placement, misaligned incentives that favor prescribing the reference product over biosimilars, and reference manufacturer-led anti-competitive practices preventing biosimilar market entry. However, there are a number of policy and procedural efforts being put in place by congressional leaders, the FDA, and HHS the could help to boost biosimilar uptake and give adalimumab biosimilars a real chance to gain market share.

Today, I’m joined by Julie Reed, executive director of the Biosimilars Forum, a nonprofit organization aimed at the advancement of biosimilar adoption through collaboration with biosimilar manufacturers. Prior to her work with the Forum, she served as vice president and global corporate affairs lead of immunology, inflammation, and biosimilars at Pfizer and she is a staunch advocate for biosimilar adoption and the advancement of biosimilar legislation, including President Biden’s 2021 executive order on increasing competition in the pharmaceutical sector and the Biosimilars User Fee Amendment III, also known as BsUFA III. Our conversation today will focus on how federal policies could shape the adalimumab market next year and what congressional leaders can do now to help the process.

This special episode is part of a larger series called “WHEN CHOICE ARRIVES: Competition & Consequences,” consisting of 4 articles and 2 podcasts. The series delves into everything that stakeholders need to know as everyone prepares for the 2023 introduction of adalimumab biosimilars.

To read part 1 of this series, “Biosimilars to Bring a Bumper Crop of Adalimumab Options,” click 

To read part 2 of this series, “For Patients and Employers, 2023 Means a Changed Landscape,” click 

To read part 3 of this series, “How Adalimumab Biosimilars Will Impact Clinicians,” click 

To read part 4 of this series, "How Payers Can Prepare for Adalimumab Biosimilars," click 

To listen to the other podcast in this series, “What Will Year 1 Look Like for Adalimumab Biosimilars?” click 

In this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, discussed current policy initiatives that could help biosimilar adoption and how the Inflation Reduction Act is expected to influence the adalimumab market.