Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

Here are the top 5 biosimilar articles for the week of December 16, 2024. 

 The impact of pharmaceutical companies' 

 on the adoption of trastuzumab biosimilars in the Netherlands led to significant price reductions and increased market share.

 found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.

 (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.

 The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and 

increases costs for biosimilar competition

submitted a European marketing application

 for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.

To read all of these articles and more, visit 

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Here are the top 5 biosimilar articles for the week of December 16, 2024.

The Top 5 Biosimilar Articles for the Week of December 16

China's trastuzumab biosimilar market is growing but lags behind European countries, with biosimilars gradually increasing market share and reducing costs despite initial barriers. | Image Credit: diy13 - stock.adobe.com

Despite rapid growth of the biosimilar industry in China, the market uptake of trastuzumab biosimilars in China is lower compared with major European countries, according to a study published in 

High costs of biologics put heavy burdens on worldwide health care systems with the global expenditure reaching $452 billion in 2022. For patients with inflammatory bowel disease, average direct health care expenses are $9000 to $12,000 per person per year in various high-income areas.

 Medication prices in the US typically surpass international costs due to lack of nationwide price regulation, the fragmentation of the health care system, prolonged market exclusivity periods, and confidential rebates negotiated between private insurers and pharmaceutical manufacturers.

It is vital to develop a balance between biomedical innovation and the sustainability of health care systems.

 Biosimilars have the potential to increase payer preferences and market share which led to major price reductions and evidence of a competitive market between 2017 to 2022.

 However, barriers persist, especially surrounding doubt about the safety and efficacy of biosimilars that lead to negative attitudes and unwillingness.

In recent years, the Chinese biosimilar industry has grown but there is limited research on the uptake of biosimilars at the national level. With the approval of the trastuzumab biosimilar, the Chinese market now has access to both individual hospitals and provincial-level administrative divisions (PLADs) to analyze a large sample size.

The study authors looked to provide evidence for promoting the clinical use of biosimilars and improve the accessibility for biological therapy, which would also help other resource-limited countries to address the issue of access to expensive bio-therapy. They conducted the study because "there is a lack of research on the uptake of biosimilars at the national level."

Researchers conducted an analysis based on monthly time series consumption data of trastuzumab in Chinese hospitals on a national scale and applied the interrupted time series regression. The latent class trajectory model (LCTM) was adopted to demonstrate provincial differences and acknowledge potential factors that may alter biosimilar market penetration across PLADs.

On a national level, trastuzumab consumption volume fluctuated upward during the observation period. After the first biosimilar was introduced in July 2021, consumption of originator trastuzumab decreased by 0.5% per month (

= .008) and the growth rate of the overall trastuzumab consumption decreased by 1.1% per month (

 = .014). The national market penetration of biosimilars expressed a moderate increasing trend that reached 27% in February 2023.

Between March 2018 to January 2020, the national consumption of the trastuzumab originator grew at a rate of 2.5% per month (

 < .001). During this period, the overall trastuzumab consumption volume showed an increasing trend, with an average monthly growth rate of 2.5% (

Following the price reduction of trastuzumab originator in January 2020, consumption dropped by 13.1% (

 = .029), accompanied by a 1.9% decrease in growth (

 = .001). In July 2021, the introduction of the first biosimilar brought a decreased growth rate of the originator consumption by 1.1% (

 = .019) with steady decreases by 0.5% per month (

When the price of the originator reduced (

 = .016), the overall consumption of trastuzumab instantly decreased by 14.7%, while the growth rate declined by 1.6% (

 = .005) and maintained a growth rate of 0.9% per month (

The LCTM fit the best when the amount of trajectory classes for biosimilar market penetration rate was 2, leading to 30 PLADs divided into a group demonstrating a faster increase in biosimilar penetration and the other with a slower increase.

There were more PLADs in the fast-increasing group with higher proportions of the population covered by the national basic health insurance but had a lower proportion of the urban population to the total population. There was also a lower proportion of the population covered by the urban employee health insurance program, a lower gross domestic product per capita, a lower total health expenditure per capita, and a lower out-of-pocket expenditure. Overall, national sales volume of trastuzumab emtansine showed average growth, reaching $1 million in September 2021 and fluctuated around $0.9 million.

Study results suggest biosimilars can invoke a transition in treatment from the originator to the biosimilars. The biosimilar market penetration in China is close to several developed countries across Asia and North America. However, uptake remains low in China compared with European countries where market shares show increases over time leading to reductions in expenditures. For instance, the Netherlands experienced significant price reductions and increased market share following the introduction of the trastuzumab biosimilar.

Limitations include a focus on hospital consumption, ultimately neglecting community pharmacies. Additionally, market fluctuations and the brief availability of biosimilars introduced barriers. The study was restricted to a single biological agent and lacked individual case study data for deeper analysis. Future research should consider a broader market perspective and quantitative analysis of competitive agents' influence.

By enhancing comprehension of biosimilars between physicians and patients while implementing provider payment reforms, competition could stimulate and foster market penetration of biosimilars.

“These measures are also meaningful for other resource-limited countries to promote biosimilar uptake and address the issue of access to expensive bio-therapy,” concluded study authors.

1. Wu Q, Wang Z, Fu Y, Luo R, Sun J. Uptake of biosimilars in China: a retrospective analysis of the case of trastuzumab from 2018 to 2023. 

. 2024;9(1):42. doi:10.1186/s41256-024-00372-z

2. Ferreri D. Making the cost of IBD care sustainable. The Center for Biosimilars

. November 2, 2024. Accessed December 16, 2024. 

https://www.centerforbiosimilars.com/view/making-the-cost-of-ibd-care-sustainable

3. Jeremias S. Commercial payer coverage of biosimilars: market share, pricing, and policy shifts. The Center for Biosimilars. December 4, 2024. Accessed December 16, 2024. 

https://www.centerforbiosimilars.com/view/commercial-payer-coverage-of-biosimilars-market-share-pricing-and-policy-shifts

4. Santoro C. Trastuzumab’s evergreening impact on biosimilars, health care costs. The Center for Biosimilars. December 13, 2024. Accessed December 17, 2024. 

https://www.centerforbiosimilars.com/view/trastuzumab-s-evergreening-impact-on-biosimilars-health-care-costs

Articles

China's trastuzumab biosimilar market is growing but lags behind European countries, with biosimilars gradually increasing market share and reducing costs despite initial barriers.

China's Biosimilar Market: Trastuzumab Uptake and Future Trends

The impact of pharmaceutical companies' evergreening strategies on the adoption of trastuzumab biosimilars in the Netherlands led to significant price reductions and increased market share. | Image Credit: Valeri Luzina - stock.adobe.com

The introduction of trastuzumab biosimilars in the Netherlands led to significant price reductions and increased market share, despite the evergreening strategy implemented by the pharmaceutical company, according to a study published in 

Major concerns exist regarding the expensive costs of medicines that apply pressure on total health care expenditures, a result of monopoly prices set by pharmaceutical companies since the drugs they manufacture are protected by patents. Original patents are usually valid for 20 years and can extend for an additional 5 years if the development process is lengthier and market authorization is successful.

The "patent dance" is a US legal process designed to streamline patent disputes between biosimilar manufacturers and reference product sponsors.

 It involves exchanging information on patents and their potential infringement, aiming to minimize future legal costs.

Pharmaceutical companies often use "evergreening" to extend drug exclusivity by filing new patents on slightly modified versions.

 This can delay the entry of biosimilars like trastuzumab, potentially leading to societal losses. Assessing the impact of evergreening on biosimilar uptake is crucial.

The study authors set out to explore “the dynamic market share and public health care costs of trastuzumab’s evergreening (subcutaneous) variant during introduction of trastuzumab’s competitive biosimilar variant in the Netherlands.”

Trastuzumab (Herceptin) was approved for the European market by Roche in August 2000 to treat patients with early-stage and metastatic breast cancers. The drug entered the market as an intravenously administered medication that drastically improves survival outcomes for patients with HER2-overexpressing breast cancer.

Trastuzumab is also one of the first biological drugs where the patent expired and an evergreening strategy was applied. The patent for the intravenous trastuzumab expired in 2014, allowing biosimilars to enter the market.

The patent for the subcutaneous administration form remains valid until 2030, limiting the current availability of biosimilars to intravenous trastuzumab.

The study utilized proprietary insurance claim data of all patients who were treated with trastuzumab in Dutch hospitals between January 2013 and December 2020. The average number of treatments per month is 3519.95 with 580.61 average treatments per hospital per year and 4628.97 for all years. About 410.48 mg of trastuzumab and 451.99 mg of the biosimilar were administered per intravenous treatment. The subcutaneous trastuzumab originator has a fixed dosage of 600 mg.

Almost all the participants were women (99.67%) with an average of 56.78 years old. Treatments were given across 73 hospitals in the Netherlands, including 8 academic hospitals, 25 top clinical hospitals, and 40 general hospitals.

The average treatment cycle of a patient consisted of 4.80 treatments of trastuzumab given in combination with chemotherapy whereas 13.16 treatments were given without chemotherapy. There was 33.13% of all intravenous-administered trastuzumab treatments (originator and biosimilars) given in combination with chemotherapy.

An upward trend was identified in the total amount of trastuzumab treatments from January 2013 until January 2014 but then decreases slightly, remaining steady at 3500 treatments per month until June 2018. Following the introduction of biosimilars in 2018, the total use increases until a peak in January 2019. A significant drop in trastuzumab treatments around April 2020 could be attributed to the COVID-19 pandemic.

When the subcutaneous trastuzumab originator was introduced in 2014, it led to a decrease in the use of the intravenous originator and an increase in subcutaneous originators up to a point in 2017 with a 50% to 50% distribution. There was a steep decline in intravenous trastuzumab originator after 2018 when the biosimilars were introduced but it is barely used a few months later. By 2020, biosimilars are used for an estimated 80% of the treatments and subcutaneous trastuzumab originator for 20%.

Hospitals displayed different uptake patterns of both subcutaneous trastuzumab following the introduction in 2014 and biosimilars in 2018. One hospital kept administering subcutaneous trastuzumab for all treatments while others switched using biosimilars for 90% of the treatments. Some hospitals decided not to switch to subcutaneous trastuzumab but replaced intravenous trastuzumab for biosimilars shortly after the introduction. Hospitals also differed in speed in which they switched to subcutaneous trastuzumab and biosimilars.

The study found the introduction of subcutaneous administration form did not change the price level of trastuzumab, whereas the introduction of biosimilars was accompanied by lowering price effects associated with biosimilars. The study also found an increased volume effect after biosimilar introduction, switching decisions made on the hospital level and influenced by patient volume, and health insurer specific effects in the use of subcutaneous trastuzumab.

The financial impact of the evergreening strategy is difficult to determine, potentially limiting study results, and should be interpreted with caution. Additionally, claims data was unable to differentiate between actual costs of administering intravenously or subcutaneously.

Future research is necessary on the impact of pharmaceutical strategies nearing patent expiration on the uptake of biosimilars and the public health care costs. A higher uptake for trastuzumab was recognized in the Dutch market that led to more competitive market structure and significant price drops.

“We recommend a more explicit societal debate to consider if the potential benefits of subcutaneous trastuzumab are worth the additional costs, and at which price it should be reimbursed as the part of the benefit package,” study authors concluded.

1. Kirshner G, Makai P, Brouns C, Timmers L, Kemp R. The impact of an 'evergreening' strategy nearing patent expiration on the uptake of biosimilars and public healthcare costs: a case study on the introduction of a second administration form of trastuzumab in The Netherlands. 

. 2024;25(7):1147-1163. doi:10.1007/s10198-023-01648-w

2. Jeremias S. Breaking down biosimilar barriers: the patent system. The Center for Biosimilars

. November 11, 2024. Accessed December 12, 2024. 

https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system

The impact of pharmaceutical companies' evergreening strategies on the adoption of trastuzumab biosimilars in the Netherlands led to significant price reductions and increased market share.

Trastuzumab’s Evergreening Impact on Biosimilars, Health Care Costs

Here are the top 5 biosimilar articles for the week of December 9, 2024. 

: Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab 

 (ustekinumab-kfce), the sixth biosimilar to reference Stelara (ustekinumab) for the treatment of inflammatory bowel disease, plaque psoriasis, and psoriatic arthritis.

 found that the adalimumab biosimilar SB5 was effective in treating rheumatic or gastrointestinal immune-mediated inflammatory diseases, showing no loss of disease control in switched patients and similar persistence rates between naive and switched groups.

Veterans with inflammatory bowel disease (IBD)

 prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.

, with increased payer preference and market share, leading to significant price reductions and evidence of a competitive market from 2017 to 2022, according to a 

The Top 5 Biosimilar Articles for the Week of December 9

Here are the top 5 biosimilar articles for the week of December 2, 2024. 

 of affordable biosimilars, with varying impacts across different jurisdictions.

 that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.

 (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.

 have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.

The Top 5 Biosimilar Articles for the Week of December 2

Patients with oncohematological diseases switching to rituximab biosimilars experienced similar safety and efficacy, highlighting biosimilars' potential for cost-effective treatment across various medical conditions. | Image Credit: sovova- stock.adobe.com

Patients with oncohematological diseases who switched from reference rituximab (Mabthera) to rituximab biosimilars demonstrated similar safety and efficacy, according to study published in 

Rituximab is a monoclonal antibody drug that attaches to and marks specific white blood cells, called B cells, for destruction.

 Patients with autoimmune conditions and types of blood cancers typically receive rituximab as a form of treatment. In 2017, both rituximab-abbs (Truxima) and rituximab (Rixathon) were approved as biosimilars of originator rituximab by the European Medicines Agency (EMA).

The development of biosimilars has led to greater access to treatments, especially in the cancer landscape, where biosimilars have effectively reduced costs of care while generating cost-savings for health delivery systems.

 By using monoclonal antibodies, advanced treatment methods have emerged, creating more options for patients.

Rituximab biosimilars have been adopted to treat hematologic malignancies, particularly non-Hodgkin lymphoma.

Wider adoption of biosimilars can be partially attributed to a stepwise approach, a process that compares the originator with the biosimilar product that the EMA, FDA, and World Health Organization follow as guideline requirements. Despite these techniques, many clinicians remain hesitant when switching patients from the reference product to the biosimilar based on concerns regarding immunogenicity or adverse reactions, despite sharing the same efficacy.

The prospective multicenter observational study set out to collect clinical information about adverse drug reactions related to the rituximab originator or biosimilars along with switching practices in patients with oncohematological diseases.

Only patients who did not have previous administrations of rituximab were considered in the adverse drug reaction analysis. The study focused on 505 (79.8%) incident cases across 13 Italian hematology centers.

Of the 505 patients (42% women) included in the study, they were either affected by non-Hodgkin lymphoma (n = 453), chronic lymphocytic leukemia (CLL) (n = 33), or 1 of the diseases included in the Italian Law 648/96 (n = 19). Patients were an average of 66.8 years old and had a median follow-up time of 317 days.

Rituximab infusions across patient populations ranged between rituximab-abbs (53%), rituximab biosimilar (24%), originator subcutaneous treatment (19%), and originator intravenous treatment (3%). Each patient had an average of 7.3 infusions.

There were 392 (78%) of the 505 naïve patients who did not receive any “switch” between both rituximab-abbs (n = 257) and rituximab (n = 130) while 113 (22%) patients experienced a “switch”. More than half of patients were treated with rituximab biosimilar combined with chemotherapy (57%). There were 25 patients who were treated with biosimilar rituximab monotherapy, including 88% who were affected by non-Hodgkin lymphoma.

“Switcher” patients (69%) switched to the subcutaneous originator (n = 78 patients) while the overall majority switched to the second infusion after receiving the initial intravenous originator (n = 40 patients), rituximab-abbs (n = 15 patients), or the other rituximab biosimilar (n = 2 patients) at the first infusion. 

Adverse drug reactions were associated with the age of the patient at diagnosis (

 < .01). They were more common among patients with indolent non-Hodgkin lymphoma (18.8%) compared with patients who had highly malignant non-Hodgkin lymphoma (15.6%), those with CLL (15.2%), and patients with conditions treated under Law 648-1996 (15.8%). There were 21 adverse drug reactions that occurred in 113 patients (18.8%) with unspecified non-Hodgkin lymphoma. The most common adverse drug reactions were general disorders and administration site conditions.

At least 16.8% of participants experienced 1 type of adverse drug reaction with higher prevalence among patients who did not switch (20.7%), especially those who received biosimilars rituximab (24.6%) and rituximab-abbs (17.9%). Adverse drug reactions were also reported more frequently among the first infusion (52%) compared with the second infusion (20%).

The COVID-19 pandemic created study limitations by delaying access to clinics with limited time dedicated by health care professionals to collect data as well as research. The pandemic had an impact on treatment decisions, introducing unprecedented challenges, disruptions in supply chains, and the need for telehealth.

The study reflects no increased adverse drug reactions when switching between biosimilars or from the originator drug to the biosimilars. Results indicate use of rituximab biosimilars is deemed safe and effective in real-world clinical practice for patients with oncohematological diseases.

These findings “can offer significant and valuable evidence that complements the findings of randomized controlled trials regarding effectiveness and safety of biosimilars in various medical conditions and treatment scenarios,” concluded the study authors.

1. Urru SAM, Mayer F, Spila Alegiani S, et al. The importance of real-world data in evaluating the safety of biosimilars: a descriptive study of clinical practice in an oncohematological Italian population. 

. 2024;16(19):3419. Published 2024 Oct 8. doi:10.3390/cancers16193419

2. Rituximab. Cancer Research UK. October 21, 2022. Accessed December 5, 2024. 

https://www.cancerresearchuk.org/about-cancer/treatment/drugs/rituximab

3. Biosimilar approvals. The Center for Biosimilars

. November 18, 2024. Accessed December 5, 2024. www.centerforbiosimilars.com. 

https://www.centerforbiosimilars.com/biosimilar-approvals

4. Malakar S, Gontor EN, Dugbaye MY, et al. Cancer treatment with biosimilar drugs: a review. 

Patients with oncohematological diseases switching to rituximab biosimilars experienced similar safety and efficacy, highlighting biosimilars' potential for cost-effective treatment across various medical conditions.

Switching to Rituximab Biosimilars Is Safe, Effective for Patients With Oncohematological Diseases

The top 5 biosimilar articles for the week of November 25, 2024. 

, an anti-HER2 antibody, to HLX02 biosimilar and XELOX (oxaliplatin and capecitabine) chemotherapy extended progression-free survival (PFS) in patients with untreated HER2-positive advanced gastric cancer. 

 introduced by Japan's 2022 health policy did not result in a reduction in overall drug costs, biosimilar use in oncology significantly increased.

 Biosimilars could improve access to biologic treatments and health care sustainability in 

, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.

 grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.

 were recognized in the US, we have only 16 products as multiple biosimilars, while more than 100 molecules await entry. This disappointment is highly touted by the associations as a great success, quoting that adopting biosimilars saves money—this was expected, but how little this saving is rarely mentioned. 

Here are the top 5 biosimilar articles for the week of November 25, 2024. 

The Top 5 Biosimilar Articles for the Week of November 25

Regulatory policies influence the availability of affordable biosimilars, with varying impacts across different jurisdictions. | Image Credit: ArtemisDiana - stock.adobe.com

Policies promoting product-specific guidance, extrapolation, shorter exclusivity periods, and substitution are linked to greater biosimilar approval and uptake, potentially increasing access to affordable biologics globally, according to an evaluation of international biosimilar policies published in the 

Biologic drugs have potential to treat serious illnesses but are often very expensive. In 2021, pembrolizumab (Keytruda) cost nearly $175,000 annually in the US.

 To address this, many countries have implemented strategies to approve similar, less expensive biologics called biosimilars.

This study compared biosimilar regulations in the European Medicines Agency (EMA), FDA, Health Canada, the Medicines and Healthcare products Regulatory Agency (MHRA), and the Therapeutic Goods Association (TGA) based on their governing laws and regulatory practices. Factors like testing requirements, indication expansion, market exclusivity, and automatic substitution, which can influence the adoption of biosimilars, were further examined.

The biosimilar must have the same amino acid sequence, comparable structure, and folding as the originator. Higher-level structure confirmation can be challenging for complex molecules as well.

Comparative nonclinical studies, often in vitro pharmacodynamic and toxicology studies, assess the biosimilar's safety. In vivo animal studies may be required by regulators, but Health Canada and MHRA often consider in vitro studies sufficient.

Comparative clinical studies, including pharmacokinetic, pharmacodynamic, and potentially efficacy trials, are conducted. Regulatory requirements for these trials vary. Some regulators may waive efficacy trials if comparability is demonstrated through pharmacodynamic studies.

Manufacturers periodically meet with regulators to review study data. This process can influence the types of studies conducted. The EMA's detailed guidance has encouraged biosimilar development and approvals. In contrast, less specific guidance from the FDA and Health Canada may contribute to fewer approvals.

Once originator biologics near exclusivity expiration, they often have multiple approved indications. As biosimilars enter the market, regulators may not require studies for each indication. Instead, biosimilars can be approved for additional indications based on their similarity to the originator biologic through extrapolation. This decision relies on similarities in disease states and pharmacologic properties.

All 5 major jurisdictions have guidance on the necessary evidence for indication extrapolation, which typically includes mechanism of action, pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity. Despite similar standards, regulators have made differing decisions on the same medications.

These discrepancies may arise from varying data requirements, approaches to extrapolation, intellectual property considerations, or manufacturer decisions regarding approval timelines.

Regulatory agencies grant originator biologics data and market exclusivities to delay biosimilar competition. Data exclusivity prevents biosimilars from relying on the originator's clinical data, while market exclusivity blocks their market entry for a specified period. These periods can overlap, and market exclusivity may extend beyond data exclusivity.

Certain market exclusivities protect specific indications, allowing biosimilar approval for other indications through a "skinny label" approach. Varied exclusivity periods and manufacturer strategies can impact biosimilar access and approval across different jurisdictions, contributing to disparities in biosimilar utilization.

A patient's receipt of an originator biologic or a biosimilar can depend on the way the prescription was written. Pharmacists may be allowed to substitute biosimilars for originators, based on local laws.

Substitution laws have boosted generic drug use, especially in the US. However, differences between generics and biosimilars create distinct regulatory roles. The 5 jurisdictions examined don't directly influence substitution decisions.

All jurisdictions require regulatory approval of biosimilar products for substitution to be allowed. While no other regulators studied have a similar influence on substitution decisions, some regulators have made statements reflecting their views on switching between reference products and biosimilars.

Medicines regulator approaches for biosimilar approvals, especially those concerning biosimilar testing requirements, indication extrapolation, exclusivities, and substitution, contribute to the overall outcome of biosimilars across various global markets.

“Reforms to these policies can create a regulatory environment more supportive of biosimilar approvals, promoting access to more affordable biologics for the benefit of patients globally,” concluded the authors.

Knox RP, Desai V, Sarpatwari A. Biosimilar approval pathways: comparing the roles of five medicines regulators. 

. 2024;11(2):1-27.  doi:10.1093/jlb/lsae020

Herman B. The Keytruda boom. Axios. October 29, 2021. Accessed November 25, 2024. 

https://www.axios.com/2021/10/29/keytruda-sales-merck-drug-prices

Regulatory policies influence the availability of affordable biosimilars, with varying impacts across different jurisdictions.

Biosimilar Approval and Uptake Impacted by Global Regulatory Frameworks

The Top 5 Biosimilar Articles for the Week of November 18

: In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the 

 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.

: Biosimilars hold the potential to dramatically 

lower health care costs and improve access

 to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.

 for Global Biosimilars Week focuses on legal barriers to biosimilar access in the US, including the patent system, and discusses ongoing legislative efforts to address these challenges.

 for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.

 for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.

Here are the top 5 biosimilar articles for the week of November 18, 2024. 

Here are the top 5 biosimilar articles for the week of October 28, 2024. 

: At the GRx+Biosims conference, a fireside chat highlighted the need to 

streamline biosimilar development and strengthen industry collaboration

, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.

: Regulatory experts and representatives from some of the top biosimilar manufacturers emphasized the importance of global harmonization and streamlining biosimilar development 

, panelists explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.

: During a fireside chat at GRx+Biosims, FDA Commissioner Robert Califf, MD, shared his perspective on key challenges and sustainability concerns in the generic drug industry, touching on pressing issues within the 

US health care system and broader global supply chain vulnerabilities

 key insights into biosimilar device requirements, emphasizing risk analysis, human factors studies, and alternative validation approaches to streamline regulatory approval for interchangeable biosimilars, while maintaining patient safety and efficacy, at the 