Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

Here are the top 5 biosimilar articles for the week of June 24, 2024. 

British Columbia's Biosimilars Initiative

 successfully saved about $732 million over 5 years by switching over 40,000 patients from reference biologics to biosimilars, while maintaining equivalent health outcomes and reinvesting the savings into the province's public payer program (BC PharmaCare) to enhance drug coverage and health care services.

 Sarfaraz K. Niazi, PhD, makes suggestions for what arguments will help 

convince the FDA to waive clinical efficacy testing requirements

 has the potential to significantly reduce cancer care costs and improve patient access to more affordable treatments, benefiting both patients and payers. However, a recent review highlights that biosimilar uptake has been hindered by various economic, practical, attitudinal, and psychological factors.

 of this series installment by The Center for Biosimilars®, the role of payers, pharmacy benefit managers (PBMs), and the financial incentives that influence prescription choices are addressed as obstacles towards affordable biosimilar treatments, specifically among underserved communities.

 to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles for the week of June 24, 2024.

The Top 5 Biosimilar Articles for the Week of June 24

IDP Analytics SVP Says IRA, PBM Legislature Reshape US Drug Costs

In an interview with Jeffrey Casberg, RPh, MS, senior vice president of pharmacy at 

, discussed policy changes and market forces that are impacting the cost of drugs. Casberg explained why he felt the Inflation Reduction Act (IRA) and pharmacy benefit manager (PBM) legislation are the most impactful.

He also touched on value-based pricing models. Although skeptical of value-based pricing being a universal solution, Casberg sees promise in its use for expensive drugs, like gene therapies, where outcomes can be more easily measured.

This transcript has been lightly edited for clarity. 

Do you foresee any policy changes or market forces that could significantly alter the cost landscape for both branded and generic drugs in the near future?

So policy or legislation, everything is about politics. I guess I'll mention 2 things. I'll mention the 

. Those would be the 2 hot ones on the IRA side, we just had the first release of the negotiated drugs and which drugs they are. We'll be getting 

, a new acronym for drug pricing, those will be announced coming up soon.

We're going to have the out-of-pocket cost of Part D reduced to the max of an out-of-pocket cost to $2,000. That's big for patients, impactful to manufacturers, and payers. Now they're going to have to deal with different benefit designs and how they're going to market the drug and price the drug or how payers are going to make the benefits work with the new $2,000 max, so there is something for everybody there.

Then 2025 redesign, for the Inflation Reduction Act, there's also quite a few different benefit designs changing for 2025. There's 

 so the manufacturers have to watch how much they're raising the prices of their drugs. If they go up too high, too quickly, then they get these penalties against them. The IRA has a number of different things, pretty complex, and everybody's paying attention to that.

Then on the second hand, it would be PBM legislation. I guess it depends on who you are and your feeling towards PBM legislation. I think it probably just comes down to more transparency. Every business has to make money and PBMs have done it. Somebody could argue they did it okay. Some say it was all smoke and mirrors but I think there's legislation now to have more transparency on PBMs. We'll see how that rolls out but a lot of discussion up in Washington on that these days.

Value-based pricing models are increasingly being explored. How do you think value-based pricing will impact the development, approval, and access to new drugs?

So value-based pricing, you hear a lot about it. You hear people trying to implement it, manufacturers bring proposals to payers on value-based pricing models. What we don't hear of are the results and if they are working or not.

I don't know in the long run, if value-based pricing will be the 'be all and end all' and change the way drugs are paid for in the United States. I'm going to say no but I think there's some value to value-based pricing and in how you look at drugs and evaluate them.

I think especially some of these high cost therapies have opportunities for some value-based models. As I was saying earlier, there's more and more of these high cost, really expensive products and looking at outcomes and measuring outcomes, that kind of thing are for these gene therapies and other expensive therapies.

I'm not saying value-based pricing will take over but I think there's opportunity in the future for use of them.

Jeffrey Casberg, RPh, MS, from IPD Analytics, explains why he believes policy changes and market forces are impacting the cost of drugs, including the Inflation Reduction Act (IRA) and pharmacy benefit manager (PBM) legislation.

IPD Analytics' Jeffrey Casberg Says IRA, PBM Legislation Reshape US Drug Costs

The Top 5 Biosimilar Articles for the Week of June 17

 A real-world study of children and young adults with inflammatory bowel disease (IBD) switched from the infliximab reference product to a biosimilar concluded 

 over 12 months based on stable remission rates and biochemical markers.

 with non-infectious uveitis from originator adalimumab to biosimilar adalimumab-atto was safe and effective, but some patients experienced the nocebo effect, where negative adverse events are caused by patients’ poor perception of the drug rather than the medication itself.

European Hematology Association’s (EHA) 2024

 annual meeting in Madrid, Spain, showed similar rates of transfusion avoidance between patients with paroxysmal nocturnal hemoglobinuria who were administered reference eculizumab (Soliris) and those administered an eculizumab biosimilar (SB12).

 British Columbia's 2019 Biosimilars Initiative, which transitioned over 40,000 patients from costly branded biologics to biosimilars, saved around 

, maintained comparable health outcomes, and reinvested the savings to improve the province's public payer program.

 Sarfaraz K. Niazi, PhD, makes suggestions for what arguments will help convince the FDA to waive 

Here are the top 5 biosimilar articles for the week of June 17, 2024.

Health Equity Chart | Image Credit: leowolfert - stock.adobe.com

In the second and final part of this series installment by The Center for Biosimilars

, the role of payers, pharmacy benefit managers (PBMs), and the financial incentives that influence prescription choices are addressed as obstacles towards affordable biosimilar treatments, specifically among underserved communities.

Part 1: Unlocking the Potential of Biosimilars to Improve Health Equity

”, highlighted the medical mistrust that underserved communities have towards health care systems and professionals. Solutions to this issue included further education among patients and physicians to attempt to close knowledge gaps while gaining trust from patients.

Part 2 shifts focus onto the professional health care systems that may be imposing boundaries towards biosimilar access through a financial lens. We will continue to investigate why biosimilars are not achieving the market adoption they deserve.

Biosimilars have the potential to increase patient access to life-saving medications at lower costs but barriers from pharmacy, physician, and insurance groups limit patient access to health equity, especially for underserved communities.

Pharmacies, Physicians, and Insurance Groups

Biosimilar barriers, often perpetrated by insurance companies, affect pharmacies and physicians as well pharmacy benefit managers, health care providers, and policymakers. Prescription drug insurance benefits are usually negotiated by managed care organizations (MCOs), integrated delivery networks, and PBMs. Research found both medical and pharmacy benefits were usually managed by MCOs or PBMs (91.7%). These high-level roles offer physician practices and institutions financial incentives, awarded to them when more expensive originator biologics are prescribed over biosimilars.

In order to understand the limited uptake of biosimilars, the 340B Drug Pricing Program must be addressed. In 1992, Congress introduced the 340B Drug Pricing Program, allowing pharmaceutical manufacturers participating in Medicare and Medicaid Part B programs to begin a contract relationship with the Secretary of Health and Human Services.

 The program requires participants to apply discounts on covered outpatient drugs when purchased by specific covered entities. Covered entities include some disproportionate share hospitals, children’s hospitals, rural hospitals, critical access hospitals, rural referral centers, sole community hospitals, and free-standing cancer hospitals. However, the 340B program has quickly turned into disadvantages for patients and manufacturers, leaving insurance companies reaping all the benefits.

Under Medicare Part B programs, drug costs are unevenly allocated among doctors and 340B participating hospitals. Where doctors typically see a 16% profit margin and hospitals make an average of 140% profit, 340B hospitals make around 210% of a profit.

 This furthers the notion that profit margins seem to be a greater focus than people in these health care systems. Commercial insurance contracts and steep discounts are likely to blame for these significant differences in profit. These policies are standing in the way of patient cost savings, allowing providers to profit from contract rebates that favor more expensive products while preventing savings from being directly passed down to patients.

Pie graph representing profit margins of doctors, hospitals, and 340B hospitals. Source: American Hospital Association

Payer-created prior authorization requirements also affect the timely treatment that could be offered to patients. As a result, patients may not feel biosimilars are worth it if they must depend on slow moving prior authorizations. As patients wait days or weeks for approval, their condition could exacerbate.

The lack of biosimilar knowledge or education among physicians does not help with uptake among patients either. Countless survey studies found evidence that physician and patient knowledge of biosimilars is insufficient, likely because they are not entirely familiar with the biosimilar regulatory approval process.

 While innovator biologics rely on clinical data to establish safety and efficacy of the innovator product, the development of biosimilars has limited reliance when compared with the biosimilar and innovator. The oncology space is likely being impacted by these concerns since recently approved cancer treatment biosimilars are not receiving adoption as fast as supportive care biosimilars have.

Additionally, biosimilar development includes the idea of extrapolation of indications, where studies utilize a patient population more sensitive to attempt to find clinically meaningful differences between the originator and biosimilar products. This allows comparative clinical studies to be waived for each indication approved for the innovator product. Many oncologists and gastroenterologists have expressed concerns over the extrapolation of indications, as well as clinicians across medical specialties.

Overall, strict mandates remove patient choice and can leave them focused on negative assumptions about biosimilars that could amplify or misattribute symptoms. These restrictions must be further researched to identify PBM price negotiations that result in patient access to expensive biologic treatment therapies.

Common obstacles patients and physicians face when attempting to achieve health equity through biosimilar access. 

Payers and PBM policies that favor more expensive reference products affect the accessibility and affordability of biosimilars, blocking biosimilars from being able to help achieve health equity. To address these systemic issues, all stakeholders will need to take action to help ensure access to biosimilar treatments.

Robert Popovian, PharmD, MS, a health economist and founder of Conquest Advisors, said in an interview with The Center for Biosimilars regarding current solutions, “We have done some policy work to shape the [biosimilar] environment but it's not enough. As you see, there's a significant struggle that the Humira biosimilars are having with regards to market penetration.”

When adalimumab (Humira) biosimilars hit the market in 2023, the assumption was competition among various similar biologic drugs would drive down prices.

 For some companies, this has been the case after choosing a dual-pricing strategy that launched the adalimumab biosimilars at 2 wholesale acquisition costs (WACs) or those that launched both branded and unbranded biosimilars at different price points.

 The idea was to ensure companies could convince PBMs to add their products on formularies (high WAC) while allowing patients without insurance to access the product at an affordable price (low WAC).

However, adalimumab biosimilars and the reference product do not guarantee cheaper costs. While some adalimumab biosimilars have steep discounts from the current price of the reference product, they are often more expensive than the originator. When the drug cost is more expensive for patients, PBMs receive a larger profit because they are awarded a portion of the drug’s list price.

A lot of adalimumab biosimilars are priced significantly lower than Humira, and some companies have launched their biosimilars with 2 wholesale acquisition costs. However, if payers and PBMs aren't willing to add these medications to formularies, the savings won't get passed to the patients. 

Pharmacy benefit managers need to be more transparent about their role, negotiation processes, and disclosure of rebate retentions to build trust from stakeholders, health care providers, and policymakers. 

The “big 3” PBMs (Express Scripts, OptumRx, and CVS Caremark) all have adalimumab biosimilars listed on the high-list price formularies.

 Market penetration can take years to show effective results so the issue surrounding adalimumab biosimilars should be addressed as soon as possible to ensure cost effectiveness later down the line and promote health equity. Samsung Bioepis reported a 53% market share after the first 3 years of the initial launch of an adalimumab biosimilar but found uptake speed differed overall among treatment spaces.

Across other companies, the uptake of biosimilars over the past 3 years ranged from 8% for drugs like insulin lispro to 82% for bevacizumab.

Near the end of 2023, adalimumab biosimilars reached only 2% of market volume. It is possible the reason for low adoption rates is based on the contracts the originators have with insurers, as well as the formulary differences of the citrate-free high potency form of the originator.

Step therapy, also known as health plan-imposed coverage exclusions, play a role in restricting access to biosimilars for patients in need. Ironically, biologics generate an average of $120 billion in drug net spending and 93% of the overall growth in total drug spending for 10 years. However, biologics account for only 2% of all patient prescriptions.

In a database analysis, 19.4% of biosimilars were restrictedly covered compared with their reference products.

 The study focused on a total of 17 health plans and found 6 plans had step therapy restrictions on biosimilars for less than 10% of all coverage decisions and 5 plans restricted biosimilars for more than 30% of all coverage decisions offered. Results found more restrictions on biosimilars if they were for diseases that had prevalence greater than 1,000,000 patients in the US. However, less restrictions were placed on biosimilars that could generate savings greater than $15,000.

The idea of penetrating health care providers with policy changes may seem impossible. However, in some instances, it has already been done and shown success. Kaiser Permanente, a large-scale insurer, has removed what most experts find to be a major issue in biosimilar uptake, known as rebate contracting.

Popovian commented, “Kaiser Permanente has made it possible to negotiate with pharmaceutical companies without using rebate contracting, proving it is possible. The insurer can gain all the savings upfront and pass it on to patients from an out-of-pocket cost perspective without using a PBM to negotiate contracts.”

The only downside to this solution is the decision to remove contract rebates lies in the hands of PBMs, which are unlikely to go along with these changes.

To combat this issue, Popovian suggested to, “delink the fees from the price of the medicine, that means to create a flat fee for any kind of services that the PBM may provide.” Another possible solution surrounds addressing benefit design for biopharmaceuticals, leaving patients unaware of the drug costs in generics and brands because it is a flat rate.

Fortunately, legislature is arising as a possible solution, suggesting portions of rebate savings to be passed through payers or patients in favor of underserved communities.

Ha Kung Wong, JD, an intellectual property attorney and partner at Venable LLP, spoke to The Center for Biosimilars on government policy, stating “[Congress] could eliminate the separate categories of biosimilar and interchangeable [products] to eliminate confusion for patients and prescribers and to allow for automatic substitution at the pharmacy level.”

Wong goes on to explain how effective this process was in Europe and how it could potentially “provide better awareness and better avenues for biosimilars to be listed higher up in insurance formularies such that patients will have access to better coverage for biosimilars.”

These examples provide evidence that policies surrounding biosimilars in the health care space can and should be changed to unlock their full potential.

In an interview, Chiara Gasteiger, PhD, of Stanford University’s Mind and Body Lab researching as a postdoctoral scholar, suggested that to combat trust issues among patients, providers, and physicians “there needs to be more transparency on the role of PBMs, their negotiation processes and disclosure of rebate retentions to build trust and understanding from stakeholders, health care providers and policymakers. Existing regulations should also ensure that PBMs comply with laws that protect patients and encourage fair pricing.”

Aside from financial and political challenges, biosimilar education remains a barrier to uptake. With some health care providers still not confident in their knowledge about biosimilars, patients are less likely to have access to these medications. Without access, biosimilars can’t aid in the fight to achieve health equity.

“More education, such as on testing and manufacturing, needs to be integrated into medical training curriculums and all providers should have access to comprehensive training programs that are regularly updated with new designations, guidelines, and policies,” Gasteiger suggested.

In addition, the introduction of electronic health records allows real time data to be exchanged among health care teams, payers, and providers because prior authorization requirements often influence timely treatment among patients. Gasteiger stressed the importance of these groups attempting to collaborate to share resources, improve ongoing communication about prior authorization, and streamline processes. The reduction of administrative complexities to be less frequent and expedited can assist with further uptake and adoption. 

Profit exceeds the amount of biosimilars prescribed. 

Insurers pose threats towards biosimilar accessibility, often for their own financial benefit, while physicians and pharmacies struggle with the limited power they hold. It is up to all health care stakeholders to work together to create a more accessible health care system and participate in frequent discussions where concerns can be addressed in a supportive environment with evidence-based policies.

Gasteiger commented, “Encouraging more research and providing research grants that enable providers to share experiences with interchangeability may also provide reassurance for some prescribers and help build trust. Research may also help professional medical organizations and other relevant organizations develop consensus statements.”

Low patient awareness and unfavorable perceptions of biosimilars stem from their physicians’ and pharmacies’ lack of awareness. Aside from overall unfamiliarity of biosimilars, providers have the power to transfer their negative expectations to patients. A study found less than 50% of the survey polled patients had heard of biosimilars and among them, 50% worried about the biosimilar being less effective than the innovator and 46% expressed concerns about the biosimilar safety profile.

A multi-pronged approach that tackles financial incentives, education, and communication is necessary to dismantle these barriers and unlock the full potential of biosimilars for improved patient access and affordability.

Despite offering substantial cost savings and improved access to treatment, particularly for underserved communities, biosimilars face hurdles within the healthcare system. Addressing these challenges through policy changes, increased education for both patients and providers, and improved communication among all stakeholders is essential to unlocking the full potential of biosimilars and expanding access to affordable treatment.

 Evolving perceptions, utilization, and real-world implementation experiences of oncology monoclonal antibody biosimilars in the USA: Perspectives from both payers and physicians. 

2. Krishnamurthy B, Kuhlman A. New error-ridden 340B study misses the mark. American Hospital Association. www.aha.org. February 7, 2024. Accessed June 3, 2024. 

https://www.aha.org/news/blog/2024-02-07-new-error-ridden-340b-study-misses-mark#:~:text=They%20examine%20the%20difference%20between

3. Boccia R, Jacobs I, Popovian R, de Lima Lopes G Jr. Can biosimilars help achieve the goals of US health care reform?. 

4. Shubow S, Sun Q, Nguyen Phan AL, et al. Prescriber perspectives on biosimilar adoption and potential role of clinical pharmacology: a workshop summary. 

5. Yu T, Jin S, Li C, Chambers JD, Hlavka JP. Factors associated with biosimilar exclusions and step therapy restrictions among US commercial health plans. 

6. Dashevsky J. The rise of Humira biosimilars and the battle for market share. Healthcare Huddle. January 28, 2024. Accessed June 3, 2024. 

https://www.healthcarehuddle.com/p/rise-humira-biosimilars-battle-market-share

7. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars. January 31, 2024. Accessed June 17, 2024. 

https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition

8. Jeremias S. Report: varied biosimilar uptake speeds pose missed opportunities for cost savings. The Center for Biosimilars. January 23, 2024. Accessed June 17, 2024. 

https://www.centerforbiosimilars.com/view/report-varied-biosimilar-uptake-speeds-pose-missed-opportunities-for-cost-savings

9. Jeremias S. Biosimilars account for 23% market share, with wide uptake disparities across molecules. The Center for Biosimilars. May 22, 2024. Accessed June 17, 2024. 

https://www.centerforbiosimilars.com/view/biosimilars-account-for-23-market-share-with-wide-uptake-disparities-across-molecules

Articles

Part 2 of this series dives into the health care system, revealing financial hurdles that limit biosimilar access and ultimately hinder health equity.

Part 2: Unlocking the Potential of Biosimilars to Improve Health Equity

Here are the top 5 biosimilar articles for the week of June 10, 2024. 

Researchers reviewed real-world evidence on the 

 of switching from tumor necrosis factor-α inhibitor originators to biosimilars in inflammatory bowel disease (IBD), prompted by mandatory switching policies in most Canadian provinces.

American Society of Clinical Oncology (ASCO) 2024

 annual meeting demonstrate positive safety and efficacy data for denosumab and pegfilgrastim biosimilars.

American and European regulatory agencies

 have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.

Sarfaraz K. Niazi, PhD, analyzes updates to the FDA's 

, as well as the agency's increased efforts to boost biosimilar adoption and education.

, part of the Association for Accessible Medicines, published a 

 advocating for updates to the FDA's regulatory process for biosimilars. The proposed changes aim to eliminate unnecessary regulatory requirements when no clinical difference exists between a biosimilar and its reference product.

Here are the top 5 biosimilar articles for the week of June 10, 2024.

The Top 5 Biosimilar Articles for the Week of June 10

Research finds switching from the originator to adalimumab biosimilar is safe and effective. | Image Credit: SpaceOak - stock.adobe.com

Patients with non-infectious uveitis exhibited similar clinical outcomes after switching from originator adalimumab (Humira) to 

 (Amgevita), showing that the 2 products exhibit comparable safety and efficacy as the safety of switching between adalimumab products, according to a study published in 

Once a patent ends for a medication, drug developers take advantage of nonmedical switching implementations, which is when patients swap medications for another for reasons not related to clinical outcomes—usually as a means to save money. However, some patients are not as eager to switch to biosimilars because they are fearful of potential loss of efficacy, changes in immunogenicity, and differences in safety compared with the originators.

There have been previous reports of “failed switches”, when patients request to switch back to the originator after unsuccessfully swapping to the biosimilar. However, this is usually due to adverse events that are not treatment emergent and are typically rooted in the patients’ personal preferences.

A retrospective research study was conducted among pediatric and adult patients with uveitis from 3 tertiary centers in the United Kingdom. The study was based on a mandatory change across all 3 institutions from reference adalimumab to adalimumab-atto.

There were 102 participants included in the analysis that switched from adalimumab to adalimumab-atto and had stopped adalimumab based on disease remission but began adalimumab-atto after a flare of disease within 6 months of stopping treatment.

Methotrexate was used to treat all pediatric patients but 25% stopped administration based on adverse effects, most commonly gastrointestinal-related nausea. Out of all the patients that stopped methotrexate, 88% switched to another disease-modifying antirheumatic drug (mycophenolate mofetil). 

Some pediatric patients had periods of time where they went off adalimumab but experienced flares of eye disease when restarting treatment.

After switching to adalimumab-atto, there was 1 case of worsening visual acuity and 2 events of improved visual acuity. Researchers did not find significant differences in the number flare cases or the dosage of glucorticosteroids used between the 2 groups. Less patients in the post-switch group had raised intraocular pressure compared with the pre-switch group. Flares were mild for both groups.

Around 20 patients reported experiencing adverse events after switching. The most common adverse event was an increased injection site pain (65.0%), with the majority of reports stemming from the pediatric patients (92.3%). Other adverse events reported included localized skin reactions, decreased vision, and technical issues with the injector device.

Less than half of the study population switched back to adalimumab (24.0%),most of whom were pediatric patients (n = 15/24). Only 1 patient that switched back had an allergic reaction to the biosimilar. Every patient that switched back to adalimumab did so based on individual request due to discomfort from the new injection device and never in relation to a flare in uveitis disease activity.

The authors noted the increased injection site pain in the biosimilar group may have been due to the biosimilar having a slightly larger gauge needle than the originator.

Biosimilar introduction was expected to be followed by market competition that resulted in decreased costs of development and affordability for patients. For adalimumab-atto to be considered more cost effective, the biosimilar would need to be 84% than the originator. The decrease in costs for bio-originator medications has the potential to offer low- and middle-income countries accessibility to biologics.

 annual meeting confirmed safety and efficacy when 

 patients with different types of psoriasis from reference ustekinumab (Stelara) to SB17, a ustekinumab biosimilar candidate, and reference adalimumab (Humira) to a biosimilar version (Imraldi).

 Similarly to patients with non-infectious uveitis, patients with psoriasis that had negative opinions towards biosimilars experienced nocebo effect-related adverse events after switching. 

 of physicians and patients, higher reports of disease severity, poor treatment adherence, and decreased quality of life were detected among groups that switched from an originator to a biosimilar.

Rheumatologists should be advised of the potential negative assumptions towards nonmedical switching and continuously exercise communication efforts to prevent negative outcomes caused by the nocebo effect.

Other factors that could contribute to the nocebo effect include patient reluctance to switching from medications they are satisfied with, provider’s lack of confidence in biosimilars, and the perception that biosimilars are low quality versions of originators.

Study limitations included limited in-person appointments during the COVID-19 pandemic, the pediatric patient population being from small area, and retrospective design.

The researchers concluded that more research is needed to optimize clinical considerations for patients switching from originators to biosimilars.

1. Murray GM, Griffith N, Sinnappurajar P, et al. Clinical efficacy of biosimilar switch of adalimumab for management of uveitis. 

2. Jeremias S. AAD posters examine clinical effects of switching to ustekinumab, adalimumab biosimilars. The Center for Biosimilars

. March 20, 2024. Accessed June 12, 2024. 

https://www.centerforbiosimilars.com/view/aad-posters-examine-clinical-effects-of-switching-to-ustekinumab-adalimumab-biosimilars

3. Ferreri D. Nocebo effect leads to switched patients reporting greater disease severity, poorer quality of life vs nonswitched patients. The Center for Biosimilars

. June 13, 2023. Accessed June 12, 2024. 

https://www.centerforbiosimilars.com/view/nocebo-effect-leads-to-switched-patients-reporting-greater-disease-severity-poorer-quality-of-life-vs-non-switched-patients

Switching patients with non-infectious uveitis from originator adalimumab to biosimilar adalimumab-atto was safe and effective, but some patients experienced the nocebo effect, where negative adverse events are caused by patients’ poor perception of the drug rather than the medication itself.

Switch to Adalimumab Biosimilar Safe, Effective for Uveitis, but the Nocebo Effect Persists

The Top 5 Biosimilar Articles for the Week of June 3

 (eculizumab-aeeb) as the first biosimilar to Soliris (eculizumab) for 2 rare diseases. It was also approved with interchangeability.

 of the use of adalimumab biosimilars in pediatric inflammatory bowel disease (IBD) in Sicily found “high rates” of clinical remission and treatment persistence, and no unexpected safety concerns.

 proved to be a big month for biosimilar research, particularly in the gastroenterology space, where new data on infliximab and adalimumab products from conferences and journals alike demonstrated positive clinical results showcasing the safety of these products as well as switching to them.

 evaluating switching patients from a biosimilar to another biosimilar revealed new data establishing the safety and efficacy of biosimilar-to-biosimilar switching.

Here are the top 5 biosimilar articles for the week of June 3, 2024. 

Here are the top 5 biosimilar articles for the week of May 27, 2024.

 Simlandi in the US; Xbrane Biopharma and STADA Arzneimitel partner with Valorum Biologics to bring a ranibizumab biosimilar to the US; Boehringer Ingelheim and Celltrion take steps to expand access to their respective adalimumab biosimilars.

 (DDW) on the ongoing LIBERTY-CD trial assessing Zymfentra, a subcutaneous infliximab product, compared with intravenous infliximab treatment in Crohn disease show the safety and efficacy of the product, as well as the impact of body mass index (BMI) on clinical outcomes.

Two posters from Digestive Disease Week found that switching patients with inflammatory bowel disease (IBD) from Remicade to an 

 did not impact clinical outcomes, with one study focusing on switches in pediatric patients and the other focusing on patients undergoing multiple switches.

Despite contributing significantly to reduced 

, biosimilars account for only about 23% of the overall biologics market, showing wide variation in uptake across different molecules, according to the IQVIA Use of Medicines in the US 

 the first 2 biosimilars referencing Eylea (aflibercept)—Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy)—for the treatment of ophthalmic conditions.

The Top 5 Biosimilar Articles for the Week of May 27

Top 5 Biosimilar Articles for the Week of May 20

 stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.

 Because of differences in how national authorities that manage drug pricing and reimbursement view health technology assessment (HTA) tools for biosimilars, there’s an urgent need for agencies to issue clear guidance on when and how to conduct HTAs for biosimilars, according to a 

 on patients with inflammatory bowel disease (IBD) switching to infliximab or adalimumab biosimilars found no change in clinical remission or antidrug antibodies after 24 weeks, but 13% experienced the nocebo effect, leading to one-fifth discontinuing therapy.

 from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states as well as cost savings.

Here are the top 5 biosimilar articles for the week of May 20, 2024. 

The Top 5 Biosimilar Articles for the Week of May 20

The Top 5 Biosimilar Articles for the Week of May 13

As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new 

 highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.

 Cordavis, a CVS Healthspire company, released a 

 detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.

 summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.

 Biosimilars offer a promising path to affordable, effective treatment, but barriers remain for underserved communities. This 

 explores the potential of biosimilars to improve health equity while addressing the obstacles that currently prevent access.

Here are the top 5 biosimilar articles for the week of May 13, 2024. 