Christina Mattina

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.

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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

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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/

Articles

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.

Numerous other patents continue to protect Humira from biosimilar competition. For instance, the PTAB denied Coherus’ petition to review another Humira patent, US 9,114,166, in 

. Another Humira patent, 9,085,619, has been challenged through the same “inter partes review” method, and a ruling from the PTAB is likely months away. Any of these rulings can be appealed by AbbVie, 

Still, Coherus plans to forge ahead with its adalimumab biosimilar, currently called CHS-1420, by skirting around the remaining patents. It aims to submit an application to the FDA by summer 2017, and hopes to launch the drug in 2018. Shares of the company’s stock had jumped by 8% hours after the board’s decision, while shares of AbbVie dropped by 2%.

“While more remains to be done, this is a significant step forward to lowering drug costs for patients and healthcare providers in the US system,” Coherus president and CEO Denny Lanfear said 

. “We believe this successful outcome validates Coherus’ leadership in biosimilar intellectual property and the effectiveness of our platform.”

Amgen’s biosimilar to adalimumab is FDA approved, but Amjevita has not yet hit the market as it is hindered by legal challenges from AbbVie. Sandoz’s adalimumab biosimilar is also progressing through the pipeline, as it 

 favorable phase 3 results. Sandoz plans to submit an application for GP2017’s approval with the FDA and the European Medicines Agency sometime in 2017.

Humira’s high revenue makes it an appealing target for biosimilar manufacturers. According to one analysis, the average cost of a yearlong course of the drug reached $27,665 in 2015, representing an increase of almost 50% from its cost in 2012. In 2016, it had $16 billion in global sales. The anti-inflammatory drug is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis.

AbbVie Loses Humira Patent Challenge to Coherus

Considering the current low levels of biosimilars knowledge among many pharmacists, a group of researchers has developed a framework for integrating education about biosimilars into the Doctor of Pharmacy (PharmD) curriculum.

American Journal of Pharmaceutical Education

, suggests that future pharmacists will need to be knowledgeable about all facets of biosimilars, from development to regulation to pharmacy practice laws, especially as more and more biosimilars are approved and enter the market.

Biosimilars teachings, the authors write, could be integrated into the 4 main domains of pharmacy education: biomedical sciences, pharmaceutical sciences, clinical sciences, and social/administrative/behavioral sciences. They proposed 4 “key educational parameters” for biosimilars that could be taught throughout the PharmD program, along with suggestions on how students’ understanding could be evaluated.

This beginner-level concept should be placed in the curriculum within the first year of the program to teach students the definition of a biosimilar and how it differs from a generic drug. Programs should also explain the risks of immunogenicity and the need to carefully evaluate safety data; this knowledge can be assessed with objective exams. “Understanding these concepts will reinforce to the PharmD graduate the importance of establishing pharmacovigilance processes to go along with the medication use processes at their institutions and practices,” the authors write.

How are biosimilars developed and regulated? 

This intermediate-level lesson should be offered in the first 2 years of the 4-year doctoral program, allowing future pharmacists to learn about the biosimilars development process, the FDA’s biosimilar approval pathway, and the data required to demonstrate extrapolation and interchangeability. “Debates surrounding the guidances in draft form by the FDA would reinforce the complex issues of naming, interchangeability, and pharmacovigilance,” according to the authors, by demonstrating that biosimilar policies are controversial.

This intermediate-level lesson would be included in other courses about medication dispensing in order to educate students about the federal and state laws surrounding biosimilar substitution, as the complexities of biosimilars make substitution more difficult than with generic small-molecule drugs. It will also review whether substitution laws apply to pharmacists practicing in non-community settings. The authors write that after presenting these lessons in lectures, “lab-based activities should be developed to ensure that students follow the proper procedures for biologic substitution, in accordance with specific state pharmacy practice laws.”

This advanced-level concept would be taught in context with other clinical therapeutics courses as a way of tying together the previously learned biosimilars information. Students would learn how to deal with biosimilars at the practice level and educate others on their use. The authors write that students could “evaluate the rationale and impact of biosimilars and require them to write policies aimed at reducing medication errors” as well as “prepare comprehensive summaries for an FDA-approved biosimilar and participate in a mock pharmacy and therapeutics committee review for formulary consideration.”

By incorporating these concepts into the pharmacy curriculum, students will graduate with an understanding of the role of biosimilars in pharmacy practice and the ability to weigh their advantages and risks.

“With this education, pharmacists will be able to provide leadership in balancing financial considerations with clinical safety and efficacy considerations in both the pharmacy and therapeutics formulary decision process as well as in the community setting,” the authors concluded. “Ensuring that graduating pharmacists are equipped with the necessary knowledge to manage daily responsibilities with regard to biologics and biosimilars will contribute toward ensuring the appropriate use of these new agents.”

, PharmD, MPH, BCOP, associate professor, Department of Pharmacy Practice, University of New England College of Pharmacy, is also an editorial board member of The Center for Biosimilars.

Framework Proposed to Incorporate Biosimilars Education Into Pharmacist Curriculum 

The European Medicines Agency (EMA), working with the European Commission (EC), has released a guide for healthcare professionals that contains essential information on biosimilars, including evidence supporting their safety and an explanation of the regulatory process.

, the guide was presented at the EC’s 3rd annual stakeholder event on biosimilars, which was attended by providers, patients, payers, and pharmaceutical manufacturers. Juan Garcia Burgos, MD, head of the EMA’s public engagement department, introduced the guide as a “comprehensive reference material” representing “a joint effort to support information and continuous education of healthcare professionals in the EU, and facilitate dialogue with patients.”

Biosimilar uptake in Europe has been significantly quicker than in the United States, as 28 biosimilars have been approved by the EMA since 2006. Still, the information in 

 indicates that some providers may have misconceptions about biosimilars or be apprehensive about prescribing them. 

One section of the guide uses a table to compare and contrast the 2 drug groups and explains why biosimilars are not the same as generic medicines. For instance, with generic drugs it is “generally possible to obtain exactly the same molecule,” while with biosimilars it is “possible to reproduce the molecule to a high degree of similarity due to unique biomanufacturing methods and natural biologic variability.” Biosimilars also must undergo a more rigorous testing protocol compared with generics, including comparability studies and safety and efficacy trials,.

This strenuous regulation of new biosimilars, according to the guide, has contributed to the drugs’ safety. “Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilar medicines and their reference medicines,” the guide says, also noting that none of the biosimilars have ever been withdrawn or suspended for safety or efficacy reasons.

The increasing use of biosimilars could have important implications for drug availability. The lower price point of biosimilars, due to market competition effects and lessened development expenses, can save money for healthcare systems and patients. “Having more treatment alternatives available is expected to improve patients’ access to biological medicines with proven pharmaceutical quality,” per the guide.

In addition to advice on switching and interchangeability, the guide includes tips on patient communication and links to resources for additional information. The European Union has been at the forefront of biosimilar development and regulation, according to the guide, which explains how the EMA’s regulatory framework has been influential in developing approval guidelines in the United States, Australia, and by the World Health Organization.

“Today, biosimilars are an integral part of the effective biological therapies available in the EU,” said professor Guido Rasi, executive director of EMA, in the press release. “Given the role of healthcare professionals on the front line of patient care, it is vital that they have access to reliable information on these medicines: what they are and how they are developed, approved and monitored.”

European Guide for Prescribers Assures Safety and Effectiveness of Biosimilars

 explains why the biosimilar drugs approved in the United States for treating chronic diseases may not result in the expected cost savings and outlines steps that can be taken to increase the market share of biosimilars.

The viewpoint outlines the history of biosimilars in the United States, from the first approval in 2015 to the present day, when 4 biosimilars have been approved for treatment of 23 indications. [The fifth biosimilar was only 

 in the United States.] The biosimilars field is expected to expand significantly in the coming years, as patent exclusivity for biologics accounting for $100 billion in sales per year will expire by 2020.

Observers have hoped that this expansion will manifest in the kind of savings seen with small-molecule drugs, where price decreases by an average 70% in the 2 years after a generic is approved, but the viewpoint explains that biosimilars for chronic diseases “are unlikely to yield widely expected cost savings” for 3 reasons:

Generic small-molecule drugs are better positioned to gain market share due to automatic substitution laws in every state that either allow or require pharmacists to automatically dispense an equivalent generic drug, as long as the prescriber does not forbid substitution. These laws do not apply to biosimilars, so the market growth of biosimilars is not guaranteed, as patients’ prescriptions must be switched from the branded reference drug to the biosimilar.

Payers are unlikely to apply the same formulary management techniques to biosimilars as they have with small-molecule drugs, where the more expensive branded drug is often not covered or costs more for the patient. Insurers have been reluctant to do the same for biologics and biosimilars, as they are apprehensive of potential pushback from patients and physicians. The viewpoint notes that the branded version of infliximab has not been left off from any major formularies in 2017 even though a biosimilar version is being sold at a 15% discount.

The last and most important factor, according to the viewpoint, is that the rebate agreements between drug companies, pharmacy benefit managers, and insurers have created a “rebate trap” in which branded drug makers threaten to revoke the rebates on the reference drug if a biosimilar enters the market at a discount. The rebate trap “ensures that payer total costs actually increase relative to costs prior to biosimilar availability,” and it can only be averted if nearly all the patients taking a biologic drug switch to the biosimilar, which is unlikely.

The viewpoint offers 3 potential solutions to address these 3 obstacles. First, it recommends that more states pass laws allowing pharmacists to substitute biosimilars that have been labeled interchangeable by the FDA, which could “bolster competition, lower prices, and increase biosimilar availability.” Next, it recommends taking cues from Europe, where biosimilars have more successfully penetrated the market, by amending treatment guidelines to recommend biosimilars, approving more biosimilars, and enacting automatic switching laws.

Finally, the viewpoint author writes that legislators in more states should propose laws to encourage drug price transparency, particularly concerning rebates. This would educate patients on how the complex system of rebates influences their course of treatment and ensure pharmaceutical companies are held accountable for price increases.

The author notes that the hurdles encountered by biosimilars are similar to those faced by generic drugs over 30 years ago; now, generic drugs are widely accepted by patients and prescribers as a safe and cost-effective treatment option.

“Once the same is true for biosimilars, the health care system will likely realize significant savings,” the viewpoint concludes.

JAMA Viewpoint Explores Barriers to Biosimilar Uptake for Chronic Diseases

The uncertainty surrounding the fate of Merck KGaA’s biosimilars unit has been resolved, as Germany-based Fresenius Kabi will buy the division for up to €670 million ($729 million).

, Merck chief executive officer Stefan Oschmann confirmed that the company was in “deep talks” to sell the division to a then-undisclosed buyer. At the time, he suggested the biosimilars arm was worth around $1 billion due to a robust pipeline of drugs in various stages of trials, although none have yet reached the market.

This pipeline, along with the biosimilars division’s approximately 70 employees based in Switzerland, will be acquired with the newly announced purchase, according to 

. The development portfolio is focused on biosimilar versions of drugs used to treat cancers and autoimmune disorders, the branded reference drugs of which currently sell for about $30 billion annually.

“The acquired biosimilars assets are an attractive opportunity for Fresenius Kabi to enter this strongly growing and highly profitable segment,” said CEO Stephan Sturm in the press release. Chief executive Mats Henriksson added that the deal will allow the company to “enhance its position as a leading player in the injectables pharmaceutical market and further diversifies its product portfolio.”

Looking to the future, the company anticipates sales to begin by the end of 2019 and grow to the “high triple-digit million” range from 2023 onwards. It will pay Merck single-digit percentage royalties determined by sales of the acquired drugs. Upon closing the deal, Merck will receive €170 million in cash, while the remaining €500 million will be distributed as “milestone payments strictly tied to achievements of development targets.”

Citing the high costs of clinical trials and regulatory requirements, Fresenius Kabi indicated that it does not expect to break even on its €1.4 billion purchase and investment ceiling until 2022, but hopes it will become profitable for the company and its shareholders by the following year.

 described the divestment as a “major step towards strategic alignment of [research and development] resources to healthcare priorities.” It also mentioned that the deal included agreements to ensure continuity through development support and manufacturing services.

“We have increasing confidence in our Biopharma pipeline and this transaction will help prioritize innovative drug development of high quality and first-to-market best-in-disease assets,” said executive board member Belén Garijo in the statement. “The partnership with Fresenius will allow us to exploit our biosimilars portfolio to full potential while granting us a substantial return on prior investments.”

The press release from Fresenius Kabi also announced its impending acquisition of Akorn, Inc, which sells prescription and over-the-counter products in the United States, at a price tag of $4.3 billion.