Christina Mattina

Alvotech and Advanz Pharma have announced a positive Committee for Medicinal Products for Human Use (CHMP) opinion for their aflibercept biosimilar, AVT06, aiming for European approval. Concurrently, Amneal Pharmaceuticals shared positive clinical trial results for Kashiv BioSciences' omalizumab biosimilar, ADL-018, targeting the US market, while Bio-Thera Solutions and SteinCares have partnered to bring a dupilumab biosimilar to Latin America.

Alvotech and Advanz Pharma announced that the European Medicines Agency's CHMP has issued a positive opinion, recommending approval for AVT06, a proposed biosimilar to Eylea (aflibercept, 2 mg).

 The decision brings the companies closer to marketing the biosimilar in the European Economic Area for various eye conditions, including wet age-related macular degeneration and diabetic macular edema. Alvotech is responsible for development and supply, while Advanz Pharma handles registration and commercialization in Europe.

“CHMP’s positive opinion takes us a step closer to being able to market our proposed biosimilar in Europe, which is excellent news for patients and their caregivers,” commented Joseph McClellan, chief scientific officer of Alvotech. The recommendation follows positive results from a 2024 clinical study confirming AVT06's therapeutic equivalence to Eylea, a drug with global sales of approximately $9 billion in 2024.

AVT06 is a recombinant fusion protein designed to bind vascular endothelial growth factors, thereby inhibiting abnormal blood vessel growth and vascular permeability, which are key mechanisms in the progression of various eye disorders. Alvotech is also developing AVT29, a biosimilar candidate for Eylea HD (aflibercept, 8 mg), and Advanz Pharma holds the distribution rights for both biosimilar candidates in the same European territories. The European Commission will make the final decision on European approval for AVT06.

Amneal Shares Results for Omalizumab Biosimilar

Amneal Pharmaceuticals has announced positive topline results from a pivotal clinical trial for ADL-018, a proposed biosimilar to reference omalizumab (Xolair), developed by Kashiv BioSciences.

 The study, involving patients with chronic idiopathic or spontaneous urticaria, successfully met its primary and secondary end points, demonstrating therapeutic equivalence and comparable safety between ADL-018 and reference omalizumab. This represents a crucial step toward making an omalizumab biosimilar available in the US.

Amneal anticipates submitting a biologics license application to the FDA in Q4 2025 and holds exclusive US commercialization rights. With Xolair's US annual sales reaching approximately $3.9 billion, ADL-018 is poised to be a significant addition to Amneal's biosimilar portfolio, enhancing access to this vital treatment.

Omalizumab is a humanized monoclonal antibody targeting free IgE indicated for various allergic conditions, including severe allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria. Expanded access to omalizumab could significantly benefit patients and health care systems by offering a more affordable treatment alternative for these conditions.

Bio-Thera and SteinCares Join Forces on Dupilumab

Bio-Thera Solutions and SteinCares have forged a new agreement to commercialize a proposed dupilumab biosimilar across Latin America. This marks their fourth collaboration, underscoring a shared commitment to enhancing access to affordable, high-quality therapies in the region. Bio-Thera will handle product development and supply, while SteinCares will manage registration and commercialization throughout Latin America.

Mitchell Waserstein, CEO of SteinCares, emphasized that the partnership reinforces their position as a leading biosimilar platform in the region, aiming to make advanced therapies more accessible and affordable. Given dupilumab's status as 1 of the top 5 medicines globally by annual sales, this biosimilar represents a significant milestone for SteinCares' expansion, potentially aiding in the treatment of chronic inflammatory conditions in both adults and children.

1. European Medicines Agency recommends market approval of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept). Press release. Alvotech; June 23, 2025. Accessed June 26, 2025. 

https://www.globenewswire.com/news-release/2025/06/23/3103152/0/en/European-Medicines-Agency-Recommends-Market-Approval-of-AVT06-Alvotech-s-Proposed-Biosimilar-to-Eylea-aflibercept.html

2. Amneal highlights positive topline results from confirmatory clinical study of biosimilar candidate to Xolair (omalizumab), developed by Kashiv BioSciences. Press release. Amneal Pharmaceuticals; June 25, 2025. Accessed June 26, 2025. 

https://www.globenewswire.com/news-release/2025/06/25/3105002/0/en/Amneal-Highlights-Positive-Topline-Results-from-Confirmatory-Clinical-Study-of-Biosimilar-Candidate-to-XOLAIR-R-omalizumab-Developed-by-Kashiv-BioSciences.html

3. Bio-Thera Solutions and SteinCares expand partnership to commercialize biosimilars for treatment of inflammatory diseases across Latin America. Press release. Bio-Thera Solutions; June 25, 2025. Accessed June 26, 2025. 

https://www.prnewswire.com/news-releases/bio-thera-solutions-and-steincares-expand-partnership-to-commercialize-biosimilars-for-treatment-of-inflammatory-diseases-across-latin-america-302490693.html

Articles

Regulators and manufacturers advance biosimilars for aflibercept, omalizumab, and dupilumab, enhancing access to treatment in Europe and Latin America.

Eye on Pharma: CHMP Aflibercept Decision; Omalizumab Results; Dupilumab Biosimilar Deal

Infliximab biosimilar initiation among pediatric patients with inflammatory bowel disease (IBD) rose gradually from 1% in 2018 to nearly 42% in 2023, with no consistent differences by age, race, or ethnicity and notable regional variation, according to a retrospective study.

, incorporated data from the ImproveCareNow (ICN) Network, a multicenter pediatric IBD quality improvement collaborative.

Pediatric IBD is becoming increasingly common, with an incidence of about 10 cases per 100,000 children in the US and Canada and a rising trend | Image credit: Art_Photo - stock.adobe.com

Pediatric IBD is becoming increasingly common, with an incidence of about 10 cases per 100,000 children in the US and Canada and a rising trend.

 In the US alone, IBD prevalence ranges from 100 to 200 per 100,000 children—amounting to an estimated 70,000 affected children—meaning that most pediatricians are likely to encounter and care for patients with IBD in their practice.

Access to FDA-approved treatments for pediatric IBD remains limited, as tumor necrosis factor-α inhibitors are currently the only class of medications approved for use in children with Crohn disease and ulcerative colitis, despite the availability of multiple therapeutic options for adults.

 Additionally, a 2018 survey by the Crohn’s and Colitis Foundation found that pediatric IBD providers were less comfortable prescribing biosimilars than their adult-care counterparts, likely due to the limited experience with biosimilars in children and the scarcity of pediatric-specific safety and efficacy data.

Although infliximab biosimilars offer a promising opportunity to reduce drug costs and expand treatment access, their uptake in pediatric populations has been slow, in part because of provider hesitancy, limited pediatric-specific efficacy and safety data, and regulatory and educational barriers.

 This retrospective cohort study was conducted to assess patterns in the initiation of infliximab biosimilars among a large pediatric IBD cohort and to determine whether differences in use existed by age, race, ethnicity, or geographic region.

Researchers prospectively collected data from 2016 to 2023 within the ICN Network to evaluate patterns in the initiation of infliximab originator and biosimilars among children and young adults with IBD, using statistical tests to assess differences by age, race, ethnicity, IBD phenotype, region, and year, while excluding patients with prior infliximab use, incomplete data, or enrollment at centers with limited infliximab prescribing.

“A notable strength is that data in the ICN Network registry are collected prospectively by clinicians. The ICN Network represents one of the largest pediatric IBD registries in existence and includes both large academic medical centers as well as small hospital-based and private practices, truly reflective of the real-world nature of pediatric IBD care,” the authors wrote.

Out of 26,256 pediatric IBD patients in the ICN registry, 4602 patients from 73 US-based centers met the study criteria and were included in the analysis. The study population was 45% female, with a median age of infliximab initiation of 13.7 years. Most patients had Crohn disease (70%). Between 2016 and 2023, 3807 patients began treatment with the infliximab originator, while 795 patients started on a biosimilar. No meaningful clinical differences were observed between the 2 groups.

Despite the introduction of infliximab biosimilars in late 2016, their uptake was initially minimal—rising from just 1% of infliximab initiations in 2018 to nearly 42% by 2023. Infliximab-dyyb (Inflectra; Celltrion) was the most commonly used biosimilar. While biosimilar use was generally consistent across age groups, a statistically significant difference was observed in 2020, likely due to the small number of children under age 6 initiating therapy that year. Similarly, 2020 was the only year with a significant difference in biosimilar use by race, with higher usage among patients categorized as “other.” No consistent differences in biosimilar use by ethnicity were observed. However, regional variation was evident, with the Midwest, West, and Southwest regions consistently initiating biosimilars at higher rates than the Northeast and Southeast from 2020 onward.

Cumulatively, just 17.3% of patients initiating infliximab from 2016 to 2023 were started on a biosimilar, reflecting a gradual but uneven adoption. The number of ICN centers using biosimilars increased significantly—from just 1 center in 2016 to 59 centers (88.1%) by 2023. The percentage of centers with very low biosimilar use (fewer than 10% of patients) steadily declined, while the number of centers with moderate (25%-69%) or high (70%-100%) biosimilar adoption grew notably. By 2023, more than half of centers had at least 25% of infliximab initiators starting on a biosimilar, highlighting a clear trend toward broader, though still variable, uptake.

This study had several limitations, including potential biases stemming from differences in how ICN centers consented patients and recorded infliximab product use, which may have led to underreporting—particularly for biosimilars like infliximab-axxq that were not explicitly tracked in the registry. The accuracy of the real-world data could not be independently verified, and missing race (8%) and ethnicity (4.6%) data may have affected analyses of disparities. Additionally, insurance type was recorded only at diagnosis, not at the time of infliximab initiation, limiting the ability to assess its influence on biosimilar use.

1. Maltz RM, Saeed SA, Adler J. infliximab biosimilar utilization in a large pediatric learning health system. 

. 2025;12(5):656. doi:10.3390/children12050656

2. Rosen MJ, Dhawan A, Saeed SA. Inflammatory bowel disease in children and adolescents. 

2015;169(11):1053-1060. doi:10.1001/jamapediatrics.2015.1982

3. Malter L, Jain A, Cohen BL, et al. Identifying IBD providers' knowledge gaps using a prospective web-based survey. 

. 2020;26(9):1445-1450. doi:10.1093/ibd/izaa032

Pediatric infliximab biosimilar use has risen significantly, reflecting evolving treatment patterns in inflammatory bowel disease (IBD) among children and young adults.

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care

The latest IQVIA Institute for Human Data Science report highlighted a crucial challenge for the biosimilar industry: bridging the knowledge gaps among health care professionals (HCPs) to unlock the full potential of these cost-efficient alternatives.

 This came as the industry continued its robust trajectory, driving significant cost savings and expanding patient access to critical biologic therapies. While the industry keeps growing fast, helping more patients access important biologic therapies and saving billions in health care costs (with Europe on track to save €56 billion by July 2024),

 there's still a noticeable gap in awareness.

Osteoporosis is a chronic condition chracterized by weakened bones that affects 1 in 2 women and 1 in 5 men aged 50 years and older. | Image credit: eddows - stock.adobe.com

“In 2023, IQVIA Institute published a report highlighting the importance of physician perspectives on biosimilars for their optimal utilization. This viewpoint continues to remain relevant, particularly as biosimilars enter new disease areas, including ones that involve complex interactions with a broad set of healthcare professionals. In such cases, different physician groups within a disease area may have varied experience with biosimilars. Ensuring that all groups are comfortable with and have knowledge about biosimilars is crucial to continue to gain the benefits from these biosimilars,” wrote Murray Aitken, executive director of the IQVIA Institute for Human Data Science, in the report’s introduction.

One area that illustrates this awareness gap is osteoporosis, a chronic condition that affects 1 in 2 women and 1 in 5 men 50 years and older.

 Biosimilars have already shown that they can save money and help more people get the treatment they need, with a 2024 report showing that they have contributed to 6.9 billion more patient treatment days across the European Union since their introduction.

 With many more biosimilars expected to launch across different conditions in the next 6 years, there’s a real opportunity to expand their impact. But as the new IQVIA report pointed out, that hinges on making health care providers more familiar—and comfortable—with using them.

Managing osteoporosis involves a range of providers, from general practitioners to specialists like rheumatologists and endocrinologists, making coordination and shared knowledge essential. In a survey of 266 European health care professionals, 73% agreed that biosimilars offer similar safety, efficacy, and cost benefits. Still, there was a clear disconnect: general practitioners (GPs) and traumatologists were much less likely to be involved in prescribing biosimilars, and only 5% of GPs showed strong awareness of what’s currently available, let alone what’s in the pipeline. It’s a sharp reminder that without broader HCP engagement, even the best biosimilar can fall short of its potential.

For the biosimilar industry, these findings could represent a call to action. While the potential for substantial savings is estimated at over €998 million in osteoporosis care alone between 2025 and 2030, the success of biosimilars in this space could hinge on overcoming these awareness deficits. The report emphasized that a lack of experience among certain HCPs, particularly those in primary care who often served as the initial point of contact for osteoporosis patients, directly impeded optimal biosimilar uptake.

The path forward, as outlined by the IQVIA Institute, involved a multipronged strategy. This included proactive sharing of best practices across health care systems, timely updates to clinical guidelines that explicitly incorporated biosimilar usage, and dedicated HCP education initiatives. Furthermore, supportive policy frameworks that incentivized biosimilar prescribing and streamlined their integration into formularies were essential.

As new biosimilars continued to gain regulatory approval and enter the market, the industry's success increasingly depended on its ability to cultivate a well-informed and confident prescriber base. The insights from this osteoporosis-focused report served as a powerful reminder that while the science and economics of biosimilars were compelling, the human element—specifically, HCP awareness and comfort—remained the critical differentiator for realizing their full market potential.

The authors concluded that “biosimilar sustainability continues to be a crucial part of ensuring optimal patient care in a healthcare system. Biosimilar markets need to ensure that appropriate incentives exist for all stakeholders to participate, thereby allowing the healthcare system to reap the benefits of biosimilar entry.”

1. Unlocking biosimilar potential: learnings from an osteoporosis case study of complex patient pathways. IQVIA Institute for Human Data Science. May 29, 2025. Accessed June 7, 2025. 

https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/unlocking-biosimilar-potential-2025

2. The impact of biosimilar competition in Europe 2024. IQVIA. January 24, 2025. Accessed June 7, 2025. 

https://www.iqvia.com/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2024

3. Non-pharmacological management of osteoporosis: a consensus of the Belgian Bone Club. 

 2011;22(11):2769-2788. doi:10.1007/s00198-011-1545-x

The biosimilar industry faces awareness challenges among health care professionals (HCPs), which must be addressed to increase cost savings and patient access to treatments.

Boosting Biosimilar Use in Osteoporosis: Why HCP Education Matters

The US pharmaceutical market has witnessed the launch of the first denosumab biosimilars, Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), marking a significant development for patients and health care systems.

 These products are now available for use across all indications of their reference medicines, Xgeva (denosumab) and Prolia (denosumab), respectively.

These biosimilars were originally approved in March 2024 and were also approved with interchangeability, meaning that they can be substituted in place of their respective reference agents (Wyost to Xgeva; Jubbonti to Prolia) at the pharmacy level without waiting for a physician to approve the switch.

Denosumab is a critical therapeutic agent used to manage conditions such as osteoporosis and cancer-related skeletal events. Osteoporosis, a condition characterized by weakened bones, affects more than 10 million US adults 50 years or older, with many more at risk.

 Bone metastases, where cancer cells spread to the bone, impact approximately 330,000 individuals in the US, often leading to painful skeletal-related events and fractures.

Keren Haruvi, president of Sandoz’ North America division, commented on the significance of this launch. "Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps improve access and affordability for US patients," he stated.

The availability of these biosimilars is anticipated to introduce increased competition within the denosumab market, which could contribute to greater affordability for patients and health care payers. Both Wyost and Jubbonti are designed to have the same dosage form, route of administration, dosing regimen, and presentation as their reference medicines. Additionally, these new biosimilars will launch with an established Q code, which is expected to facilitate reimbursement processes.

Organizations focused on patient advocacy have welcomed the development. Claire Gill, CEO of the Bone Health and Osteoporosis Foundation, noted the potential positive impact. "Bone loss and cancer-related skeletal complications can have a profound impact on patients’ lives, but access to effective treatments has often been impacted by cost. With the introduction of new biosimilar options, patients now have access to more treatments they need and deserve," Gill said.

Support resources for patients prescribed Wyost and Jubbonti, including reimbursement and financial assistance programs, are also being provided. The entry of these interchangeable denosumab biosimilars into the US market signifies the potential for wider availability of more affordable treatment options for patients requiring denosumab therapy.

1. Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients. Sandoz. June 2, 2025. Accessed June 2, 2025. 

https://www.sandoz.com/sandoz-launches-first-and-only-interchangeable-denosumab-biosimilars-us-providing-new-affordable/

2. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars

https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

3. Osteoporosis: from the FDA Office of Women's Health. FDA. Updated May 13, 2024. Accessed June 2, 2025. 

https://www.fda.gov/consumers/womens-health-topics/osteoporosis

4. Bone metastasis. Moffitt Cancer Center. Accessed June 2, 2025. 

https://www.moffitt.org/cancers/bone-metastasis/

Denosumab biosimilars Wyost and Jubbonti launch in the US, enhancing access to affordable treatments for osteoporosis and cancer-related skeletal events.

Wyost and Jubbonti Launch as First Denosumab Biosimilars in the US

Robert F. Kennedy Jr. confirmed as HHS Secretary, despite vaccine skepticism and controversial health views.

His confirmation faced scrutiny over financial ties to vaccine litigation and shifting abortion stances.

Kennedy's agenda includes promoting healthier foods, tackling pollution, and addressing chronic disease causes.

Concerns arose over his lack of clear plans for Medicare and Medicaid funding structures.

His tenure is expected to bring significant changes to health policy, closely watched by both political parties.

, the US Senate made Robert F. Kennedy Jr the nation’s top health official as secretary of HHS.

 The vote comes after intense confirmation hearings and tense committee votes in which it appeared some Republicans were struggling with the choice, but the majority party has now thrown their support behind the longtime vaccine skeptic, critic of processed foods, and initiator of the Make America Healthy Again agenda.

The lone Republican holdout was Sen Mitch McConnell (R, Kentucky), a polio survivor who has taken issue with Kennedy’s decades of opposition to vaccines. McConnell has also voted against confirming some other nominees in the new administration, including Tulsi Gabbard as director of national intelligence and Pete Hegseth to lead the Department of Defense.

President Donald Trump’s initial announcement of Kennedy as his pick to lead HHS was met with both 

 Proponents are enthusiastic about his pledges to promote healthier foods, tackle pollution, address root causes of chronic disease, and ban prescription drug ads. Mainstream public health voices, however, have raised concerns about his long history of false statements about vaccines and touting of raw milk and unproven COVID-19 “cures.”

After a rocky path to confirmation, the Senate on Thursday made Robert F. Kennedy Jr the nation’s top health official as secretary of HHS. | Image credit: Lila Patel - stock.adobe.com

The path to Kennedy’s confirmation was rocky, with Democrats drawing attention to his 

, which included stakes in lawsuits against vaccine makers including Merck.

 He resigned from his nonprofit, Children’s Health Defense, which is known for its antivaccine efforts, and during the confirmation hearings agreed to 

 in fees from litigation against Merck over the human papillomavirus vaccine.

, Kennedy maintained that he is not antivaccine, but rather calling for greater transparency around the safety and effectiveness of vaccines.

 Still, he pushed back on widely accepted meta-analyses that show the safety of vaccines and instead cited papers with 

 purporting to show associations between vaccines and neurodevelopmental disorders.

After a rocky path to confirmation, the Senate on Thursday made Robert F. Kennedy Jr the nation’s top health official as secretary of HHS. | Image credit: Magic Art - stock.adobe.com

 during his hearings also garnered criticism.

 He acknowledged not yet having a specific plan for aligning Medicare and Medicaid funding structures, and at times appeared to 

, including making the incorrect statement that Medicaid is “fully paid for by the federal government.”

 He also painted a picture of Medicaid as having premiums and deductibles that are too high; premiums and deductibles are 

 although enrollees report barriers to accessing care, such as 

Both Democrats and Republicans took issue with Kennedy’s shifting stances on abortion, which were rehashed throughout the confirmation hearings.

 Democratic senators brought up that as recently as March 2024, he had said he supported a woman’s right to choose abortion “throughout the pregnancy,” and accused him of ceding his beliefs for political gain. Meanwhile, some conservatives including former Vice President Mike Pence aimed to 

 but Republican senators largely did not press the issue during the hearings. When questioned about abortion by Democrats, Kennedy 

: “I agree with President Trump that every abortion is a tragedy. I agree with him we cannot be a moral nation if we have 1.2 million abortions a year. I agree with him that the states should control abortion.”

During the hearings, Sen Bill Cassidy (R, Louisiana) asked Kennedy tough questions about his history of vaccine skepticism and embrace of flawed science claiming links between vaccination and autism.

 Cassidy, a physician, admitted that he was grappling with whether to advance Kennedy’s nomination, but ultimately decided to 

 to the full Senate vote, stating, “With the serious commitments I’ve received from the administration and the opportunity to make progress on the issues we agree on, like healthy foods and a pro-American agenda, I will vote yes.”

Now, with Kennedy officially confirmed to head HHS, he will be handed a portfolio of thorny issues ranging from compliance with 

 to overseeing the administration’s policies on 

 and more. His tenure as HHS secretary portends a status quo shakeup that will be closely watched by both sides of the aisle.

US Senate 2025-02-13. C-Span. Accessed February 13, 2025. 

https://www.c-span.org/event/us-senate/us-senate/430935

Joszt L. Support and skepticism emerge as reactions to Robert F. Kennedy Jr’s HHS nomination. 

. November 15, 2024. Accessed February 13, 2025. 

https://www.ajmc.com/view/support-and-skepticism-emerge-as-reactions-to-robert-f-kennedy-jr-s-hhs-nomination

Bonavitacola J. Kennedy reveals key decisions in ethics report as confirmation hearing looms. 

. January 23, 2025. Accessed February 13, 2025. 

https://www.ajmc.com/view/kennedy-reveals-key-decisions-in-ethics-report-as-confirmation-hearing-looms

Jewett C, Craig S. Kennedy says he will not keep fees from HPV vaccine litigation. 

. January 30, 2025. Accessed February 13, 2025. 

https://www.nytimes.com/2025/01/30/health/rfk-jr-hpv-vaccine-lawsuits-fees.html

Steinzor P. 5 key takeaways from RFK Jr’s confirmation hearings. 

. January 31, 2025. Accessed February 13, 2025. 

https://www.ajmc.com/view/5-key-takeaways-from-rfk-jr-s-confirmation-hearings

Steier J. Anatomy of a failure: why this latest vaccine-autism paper is dead wrong. Unbiased Science. January 25, 2025. Accessed February 13, 2025. 

https://theunbiasedscipod.substack.com/p/anatomy-of-a-failure-why-this-latest

Grossi G. RFK Jr fails to offer a clear Medicaid, Medicare strategy. 

. January 29, 2025. Accessed February 13, 2025. 

https://www.ajmc.com/view/rfk-jr-fails-to-offer-a-clear-medicaid-medicare-strategy

Cost sharing. Medicaid.gov. Accessed February 13, 2025. 

https://www.medicaid.gov/medicaid/cost-sharing/index.html

Hest R. Assessing physician acceptance of Medicaid patients using State Health Compare. State Health Access Data Assistance Center. August 25, 2022. Accessed February 13, 2025. 

https://www.shadac.org/news/14-17-physician-Mcaid-SHC

Stolberg SG. Pence wages lonely crusade against Kennedy as abortion opponents avoid fight. 

. January 24, 2025. Updated January 31, 2025. Accessed February 13, 2025. 

https://www.nytimes.com/2025/01/24/us/politics/pence-kennedy-abortion.html

Watch: ‘every abortion is a tragedy,’ RFK Jr says. PBS. January 29, 2025. Accessed February 13, 2025. 

https://www.pbs.org/newshour/politics/watch-every-abortion-is-a-tragedy-rfk-jr-says

Munz K. RFK Jr confirmation for HHS secretary advances to full Senate after committee votes. 

. February 4, 2025. Accessed February 13, 2025. 

https://www.ajmc.com/view/rfk-nomination-advances-to-full-senate

Grossi G. FDA quietly removes draft guidance on diversity in clinical trials following executive order on DEI. 

https://www.ajmc.com/view/fda-quietly-removes-draft-guidance-on-diversity-in-clinical-trials-following-executive-order-on-dei

Bonavitacola J. Americans claim health care access is top priority in public health. 

. February 6, 2025. Accessed February 13, 2025. 

https://www.ajmc.com/view/americans-claim-health-care-access-is-top-priority-in-public-health

Steinzor P. Trump reverses some Biden drug pricing initiatives, potentially impacting Medicare costs. 

. January 22, 2025. Accessed February 13, 2025. 

https://www.ajmc.com/view/trump-reverses-some-biden-drug-pricing-initiatives-potentially-impacting-medicare-costs

Klein HE. FTC report highlights prescription drug price markups by PBMs. 

. January 14, 2025. Accessed February 13, 2025. 

https://www.ajmc.com/view/ftc-report-highlights-prescription-drug-price-markups-by-pbms

The Senate voted 52-48 to confirm Robert F. Kennedy Jr as secretary of HHS, setting up the vaccine skeptic to carry out major changes in pursuit of his Make America Healthy Again agenda.

Robert F. Kennedy Jr Confirmed as HHS Secretary, Nearly Along Party Lines

Robert Califf, MD, received Senate approval today to become FDA commissioner in a 50-46 vote, in which 6 Republicans supported him and 5 Democrats voted against his confirmation.

 1 senator who has been opposed to the nomination instead voted “present,” out of deference to colleague, Senator Ben Ray Lujan of New Mexico, who is recovering from a stroke.

Califf, a highly cited cardiologist and a founder of the Duke Clinical Research Institute, has recently served as a senior advisor to Verily and Google Health. He led the FDA during the final 11 months of the Obama administration, but his path confirmation this time has been rocky since he was nominated in November 2021. As recently as Friday, Senator Joe Manchin, D-West Virginia, 

 calling on Biden to withdraw Califf’s nomination. Manchin castigated Califf’s ties to the pharmaceutical industry and the FDA’s approval of 5 new opioids during his previous tenure as commissioner.

Joining Manchin in voting against Califf were fellow Democrats Senators Richard Blumenthal of Connecticut; Maggie Hassan of New Hampshire, and Ed Markey of Massachusetts, along with Bernie Sanders, I-Vermont.

Califf’s nomination also drew opposition from most Republicans, including antiabortion advocates who scrutinized his record on easing access to abortion medications. However, 6 Republican senators voted to confirm Califf’s nomination: Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania.

The FDA has lacked a permanent, Senate-confirmed commissioner since Stephen Hahn, MD, left the role on President Donald Trump’s last day in office. Long-serving FDA official Janet Woodcock, MD, had been acting as commissioner for more than a year, but her tenure brought controversy, notably the approval aducanumab (Aduhelm) for Alzheimer disease. Woodcock had called for 

 of the administration’s actions in its relationship with the manufacturer, Biogen.

In addition, Califf will need to guide the FDA through the ongoing COVID-19 pandemic—including the decision on whether to authorize a vaccine for children under 5 years—and a host of other pressing issues, including e-cigarette marketing applications.

, 3 former FDA commissioners and a former CMS official urged the Senate to confirm Califf, writing that "it is long past time to have confirmed leadership at the FDA." Former commissioners Scott Gottlieb, MD, and Mark McClellan, MD—who served in Republican administrations—along with Obama administration veterans Margaret Hamburg, MD; and Andy Slavitt, former acting CMS administrator and member of President Biden's COVID-19 response team last year, said that Califf can "hit the ground running" to deal with the country's urgent, unmet health needs.

The Association for Accessible Medicines (AAM) had previously announced support for Califf when Biden announced the nomination in November, saying the group and its member companies “stand ready to work with Dr Califf and the entire FDA team to ensure America’s patients have timely access to safe, effective and quality generic and biosimilar medicines.”

In a 50-46 vote, the Senate confirmed Robert Califf, MD, as President Biden’s FDA commissioner. The agency has been without a permanent leader for more than a year.

Califf Wins Narrow Senate Vote for Second Turn as FDA Commissioner

The Competition and Markets Authority (CMA) of the United Kingdom has announced it is investigating whether Merck unfairly offered a discount scheme to protect sales of its drug infliximab (Remicade) against competition from new biosimilars hitting the market.

According to the CMA—a governmental office that regulates fair market competition in England, Scotland, Wales, and Northern Ireland&mdash;the investigation has been ongoing since December 2015. This week, 

 the issuance of a “statement of objections,” which alleges wrongdoing but is not a conclusive finding of guilt. Its provisional statement is that Merck “operated an anti-competitive discount scheme” by “abusing its dominant position” in the market.

 on the case indicates that Merck’s discount scheme was employed “in relation to the supply of Remicade to the NHS.” The National Health Service is the largest buyer of pharmaceuticals in the United Kingdom, and drug prices are determined through negotiations between manufacturers and the government.

The alleged scheme was employed to ensure sales of infliximab remained steady despite influx of cheaper infliximab biosimilars hitting the European market around that time. For instance, Inflectra and Remsima were approved by the European Medicines Agency in September 2013, while Flixabi was approved in May 2016.

 from October 2015, Merck had offered the NHS discounts and rebates of about 25%, or £48 million off of £191 million in sales. A company spokesman said that the 2 competing biosimilars were being sold at discounts of between 25% and 30%. However, a representative of Napp Pharmaceuticals responded that its biosimilar Remsima had actually been sold to the NHS for prices 40% to 50% lower than the list price of Remicade.

In response, Merck Sharpe & Dohme (MSD), the overseas arm of Merck & Co, 

 denying the accusations. Both MSD and the New Jersey-based Merck & Co could be found jointly liable by the CMA of violating competition law, but the statement projected confidence that the ongoing investigation would absolve both of wrongdoing. “The discounts in question meant that infliximab was competitively priced and offered savings to the UK National Health Service, without hindering competition,” it explained.

Remicade, a tumor necrosis factor inhibitor used to treat autoimmune diseases, is sold in the United States by Johnson & Johnson and licensed to MSD for international sales. With the FDA’s approval of Renflexis in April 2017, a year after the first biosimilar for infliximab (Inflectra) was approved, Johnson & Johnson is also facing cost pressures from new competition. However, the biosimilars have not significantly eaten into Remicade’s market position in the United States, as they have not been deemed interchangeable and Inflectra was priced at only a 15% discount to Remicade.

UK Authority: Merck Used Illegal Discounts to Defend Against Biosimilar Competition to Remicade

A study based on claims data and adverse event reports compared the medical costs linked to infections in patients taking 3 different biologics: certolizumab (Cimzia), adalimumab (Humira), and etanercept (Enbrel).

, presented at the ISPOR Annual Meeting in Boston, MA, this week, adverse drug events (ADEs) are a dangerous and common occurrence, as they represent the fourth leading cause of death in the United States and are responsible for 700,000 emergency department (ED) visits per year. However, it can be challenging to determine the medical costs related to ADEs using claims databases.

Researchers from Advera Health Analytics and WEA Trust gathered data from Advera’s analytics platform on ADEs reported to the FDA and compared it to the WEA Trust’s claims database “to determine whether spontaneous ADE reporting analysis could be used as a proxy for claims-based outcomes studies.” They used data from both sources for the time period of August 2013 through July 2015, as well as drug usage information and the medical costs specific to each ADE.

Using the WEA Trust data, the authors determined that certolizumab had a drastically higher rate of associated pneumonia than adalimumab and etanercept (13.6% vs 0.5% and 0.9%, respectively). Not surprisingly, certolizumab was also responsible for increased costs to the healthcare system. Each prescription of certolizumab was associated with $522 in ED costs and $156 in hospitalization costs, about double the expenses associated with adalimumab ($256 in ED costs and $79 in hospitalization costs). The costs associated with etanercept were the lowest of the 3 drugs, at $190 in ED costs and $57 in hospitalization costs.

The ADE data provided to the FDA confirmed that certolizumab was responsible for significantly more reports of pneumonia. It also indicated that certolizumab resulted in higher downstream costs per prescription from both serious ADEs and patient outcomes than the other 2 drugs. When comparing the costs calculated with claims data to the FDA-reported events, the researchers found that the “per dispense medical cost in the WEA Trust claims data correlated to Advera Health’s calculated downstream medical cost from FAERS [FDA Adverse Events Reporting System] data.”

Tumor necrosis factor (TNF) inhibitors, are widely prescribed to treat autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory disorders. The WEA Trust, an insurer in Wisconsin, plans to use these findings to work with providers so they can modulate TNF-α inhibitor prescriptions to lower cost and improve safety.

In 2016, biosimilars of both etanercept and adalimumab were approved by the FDA. However, marketing of both has been 

, as Amgen’s Amjevita (adalimumab) is being challenged by AbbVie, the maker of Humira. Simultaneously, Amgen is involved in a 

 over Novartis’s Erelzi (etanercept), the biosimilar of Enbrel.

The FDA has not yet approved any biosimilars of certolizumab, although a version being developed by PFEnex is currently in the preclinical stages of the pipeline.

Certolizumab Responsible for Higher Costs, Pneumonia Rates Than Adalimumab, Etanercept 

The Patent Trial and Appeal Board (PTAB), part of the US Patent and Trademark Office, has ruled in favor of biosimilar manufacturer Coherus, striking down one of the patents protecting adalimumab, sold as Humira (adalimumab) by AbbVie.

The compound patent for Humira expired in 2016, but there are a number of other individual patents protecting specific formulations and dosages of the drug. The PTAB’s recent ruling applies to Patent 8,889,135, which “covered subcutaneous dosing of 40 mg of Humira every 13 to 15 days for treatment of rheumatoid arthritis,” 

. However, rheumatoid arthritis is not Humira’s only indication, and it makes up just one-third of its total use.