Biosimilars/Research

Cost-savings from higher biosimilar uptake and more appropriate use of ESAs

Biosimilars/Research | Posted 14/05/2021

Chronic kidney disease (CKD) is a growing public health issue worldwide. In Italy, the prevalence of CKD is 7.5% in men and 6.5% in women [1]. In Italy, the annual direct costs of management for patients on dialysis were estimated to be around €30,000 for peritoneal dialysis and €44,000 for haemodialysis [2]. Erythropoiesis-stimulating agents (ESAs) have a significant economic burden in CKD as they are widely used to treat CKD-related anaemia; biosimilars can guarantee a 20%–30% saving on ESA purchase costs in CKD patients [3].

Biosimilars for skin conditions safe and effective

Biosimilars/Research | Posted 14/05/2021

Two recently published articles [1, 2] assessing the use of biosimilars for the long-term skin conditions psoriasis and hidradenitis suppurativa indicate that biosimilar treatments are equally as effective as the originator, demonstrating similar drug retention and clinical response rates, respectively.

Study supports advanced IV preparation and storage of ABP 215

Biosimilars/Research | Posted 07/05/2021

The first approved bevacizumab biosimilar, ABP 215 (Mvasi), can be prepared in bag, over a month prior to being used to treat patients via intravenous (IV) infusion, shows a study published in GaBI Journal [1]. The study reveals that ABP 215 retains physicochemical stability after dilution and storage, which can ease the process of drug administration in clinical settings.

A positive outlook for the US biosimilars market

Biosimilars/Research | Posted 30/04/2021

The US is keeping pace with the European pioneers of biosimilars approvals, reveals an article published in GaBI Journal [1].

Expanding access to trastuzumab biological treatments

Biosimilars/Research | Posted 30/04/2021

The anti-human epidermal growth factor receptor 2 (HER2) monoclonal antibody trastuzumab is indicated for treatment of HER2-positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Often used in conjunction with chemotherapy, trastuzumab was originally approved as an intravenous (IV) formulation. Subcutaneous (SC) formulations were more recently approved for HER2-positive breast cancer in 2013 (Europe) [1] and 2019 (US) [2].

CADTH summarizes evidence on switching to etanercept biosimilars

Biosimilars/Research | Posted 23/04/2021

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA), known today as CADTH, is an independent, not-for-profit organization responsible for providing Canada’s healthcare decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our healthcare system.

Relieving the economic burden on EU healthcare budgets: spotlight on IV trastuzumab and rituximab biosimilars

Biosimilars/Research | Posted 23/04/2021

In an ageing society with increasing medical need, biological treatments have played a key role in reforming the management of cancer, autoimmune and certain preventable diseases. Yet, biological treatments impose a significant financial burden on the healthcare system and healthcare payers.

Characteristics associated with biosimilar use in Medicare recipients

Biosimilars/Research | Posted 16/04/2021

What patient, physician and practice characteristics are associated with biosimilar usage for the biologicals filgrastim and infliximab was a question asked by researchers from the US [1].

Biosimilars in the treatment of psoriasis

Biosimilars/Research | Posted 16/04/2021

A recent paper by Spanish dermatologists reviews the principles of biosimilarity and equivalence trials that have led to the approval of the available adalimumab biosimilars [1]. Given the current sophistication of the analytical processes, the need to include therapeutic equivalence trials for some drug classes might be eventually waived, but they are currently standard. Equivalence trials are designed to establish that the efficacy and safety of the biosimilar are similar to those of the reference biological, with a predetermined margin of equivalence that in psoriasis ranges from ±14% to ±18%. Lower margins would imply potentially unaffordable sizes of treatment groups. The primary endpoint of the study and the timing of the determination may or may not be the same as those used in the pivotal trials of the reference biological, but the number of patients included is intentionally lower; the statistical design of equivalence trials is currently the subject of active research. In many equivalence studies, biosimilars obtain response rates higher than those reported in the pivotal studies for the originator, probably because of the absence of a placebo arm, which would tend to raise researchers’ and patients’ efficacy expectations.

Adalimumab biosimilar FKB327 causes less pain than originator

Biosimilars/Research | Posted 09/04/2021

Fujifilm Kyowa Kirin Biologics’ adalimumab biosimilar FKB327 has been found to cause less injection-site pain compared to the reference product, according to data from more than 1,001 subjects and patients [1].

Biosimilars regulation, clinical trials, approval and adverse events in Malaysia

Biosimilars/Research | Posted 09/04/2021

Compared to chemical drugs, biologicals are more expensive because of their complicated manufacturing processes. Patients often use biologicals for long-term therapy, which may exert huge budgetary pressure on healthcare systems. One alternative solution to address this issue is to use biosimilars that are similar to the originator biologicals, with no clinical differences in terms of quality, efficacy, safety and immunogenicity. In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) approved the country’s first biosimilar, somatropin, in 2010. Since then, the number of approved biosimilars and clinical trials on biosimilars continue to rise. With increased use of biosimilars, an increased number of adverse events (AEs) is expected because like any other biological, they may elicit immunogenic reactions.

Etanercept biosimilar injection pen, YLB113, convenient and easy to use

Biosimilars/Research | Posted 02/04/2021

A study of an injection pen formulation of the etanercept biosimilar YLB113, which is manufactured by the Japanese firm YL Biologics, finds it to be convenient and easy to use and convenient among patients with rheumatoid arthritis [1].

Samsung Bioepis and Eden Biologics announce new biosimilars trials

Biosimilars/Research | Posted 02/04/2021

In early 2021, Samsung Bioepic and Eden Biologics announced advances in the clinical trials of their respective ustekinumab and denosumab biosimilars.

Public health impact of using biosimilars and relevance of automated follow-up

Biosimilars/Research | Posted 26/03/2021

Biological reference drugs and biosimilars have highly complex structures. Biosimilars need to demonstrate their biosimilarity during their development but unpredictable variations can remain, such as micro-heterogeneity. The healthcare community may raise questions regarding the clinical outcomes induced by this micro-heterogeneity. Indeed, unwanted immune reactions may be induced for numerous reasons, including product variations. However, it is challenging to assess these unwanted immune reactions because of the multiplicity of causes and potential delays before any reaction. Moreover, safety assessments, as part of preclinical studies and clinical trials, may be of limited value with respect to immunogenicity assessments because they are performed on a standardized population during a limited period. Real-life data could therefore supplement the assessments of clinical trials by including data on the real-life use of biosimilars, such as switches. Furthermore, real-life data also include any economic incentives to prescribe or use biosimilars.

Pelmeg developed with aid of regulatory reform

Biosimilars/Research | Posted 19/03/2021

The development of Pelmeg, a biosimilar of pegfilgrastim, revealed flexibility in the regulatory guidelines as they were superseded by state-of-the-art science, a study uncovers [1].

Knowledge and perceptions about naming biosimilars in the US

Biosimilars/Research | Posted 19/03/2021

Following the introduction of biosimilars, naming conventions for biologicals have been introduced, in part to support pharmacovigilance.

Infliximab biosimilars for IBD patients: experience from Italy

Biosimilars/Research | Posted 12/03/2021

In the last 20 years, biological drugs have become the mainstream therapy for patients affected by moderately-to-severely active inflammatory bowel disease (IBD), even though they are associated with a significant increase in health-related costs. After the expiry of patents on originator drugs, the advent of antitumour necrosis factor alfa (TNF-α) biosimilars resulted in considerable cost-savings and increased patients’ access to these drugs. After having completed registration trials in rheumatic diseases [1, 2], the infliximab biosimilar CT P13 obtained approval based on a comprehensive comparability exercise, for all other indications, including IBD. Accordingly, physicians started to increasingly prescribe biosimilars for patients with IBD – including those that were both anti-TNF-α naïve and experienced. There is growing evidence that early introduction of biological therapy in IBD is associated with more favourable outcomes in the medium to long term. Keeping that in mind, it follows that the advent of biosimilars has the potential to allow more patients to have access to biological therapy at an earlier stage of disease, which could contribute to prevent disease progression and damage accumulation, with a consequential improvement in patients’ quality of life.

Efficacy and safety of interferon beta-1a (ReciGen) in COVID-19

Biosimilars/Research | Posted 05/03/2021

Since COVID-19, caused by SARS-CoV-2, emerged as a worldwide concern and was declared a pandemic, finding a safe and effective treatment for this disease has been a top priority. Different treatment candidates, including interferon [1], remdesevir [2], tocilizumab [3], and dexamethasone [4] have been investigated in multiple clinical trials.

Improving biosimilar use in clinical practice

Biosimilars/Research | Posted 26/02/2021

Uncertainty about biosimilars and lack of motivation among healthcare providers and patients to use them may have been curbing biosimilar use. Guidance on how to implement biosimilars in clinical practice and how to incentivize stakeholders to use biosimilars may help to realize the benefits offered by biosimilars for healthcare systems and patients.

Improving stakeholder understanding about biosimilars

Biosimilars/Research | Posted 19/02/2021

The arrival of biosimilars provides benefits for healthcare systems and patients by lowering treatment costs and improving patient access to biologicals. Despite these benefits and demonstrated comparability with the reference biological, the use of biosimilars varies across regions and remains limited in some cases. This may be partially due to a lack of knowledge and understanding among healthcare professionals and patients about biosimilars, limiting their willingness to use them.

Interchangeability, naming and pharmacovigilance of biosimilars

Biosimilars/Research | Posted 12/02/2021

Results of a survey was carried out by the World Health Organization (WHO) revealed that challenges still remain when it comes to the regulatory evaluation of biosimilars [1].

Improving the understanding of biosimilars through education

Biosimilars/Research | Posted 12/02/2021

The process of introducing biosimilars into clinical practice is complex and involves many stakeholders. There are different strategies that healthcare systems have adopted to incorporate biosimilars into patient care. Regulators, payers, pharmacists, and physicians need adequate knowledge in order to be effective components of this process. Previous research in the region has shown a high prevalence of lack of understanding and major safety concerns on the use of biosimilars [1].

Understanding and minimizing injection-site pain for biologicals

Biosimilars/Research | Posted 05/02/2021

Biologicals have revolutionized treatment across a range of immune and inflammatory-related diseases and have had considerable impact on the health economy. Switching to a biosimilar has proven to be an effective, safe and pharmacoeconomically advantageous strategy for health systems.

Clinical evidence for interchangeability of biosimilars in the US

Biosimilars/Research | Posted 29/01/2021

In the United States, the Food and Drug Administration (FDA) approval of a biosimilar is based on the ‘totality of the evidence’ from comparative analytical and functional assessments and comparative clinical (pharmacology, immunogenicity, safety and efficacy) assessments that support a conclusion of biosimilarity [1]. An approved biosimilar can also be designated as ‘interchangeable’ if it can be concluded that the biosimilar is expected to produce the ‘same clinical result as the reference product in any given patient’ and there is no increased risk in terms of safety or diminished efficacy associated with switching or alternating between the biosimilar and reference product (RP) [2]. With such designation, an interchangeable biosimilar could be substituted for its RP at the pharmacy level where state law allows [2].

How organizations worldwide are producing HTA reports for biosimilars

Biosimilars/Research | Posted 22/01/2021

The vital contribution of Health Technology Assessment (HTA) is well recognized and consolidated in scientific and technological practice; however, there is still no generally accepted position on its utilization in relation to biosimilars.

Influence of local policy measures and practices on biosimilar/originator market dynamics in Germany

Biosimilars/Research | Posted 15/01/2021

In Europe, the individual Member States are responsible for designing policies that regulate the market entry and use of pharmaceuticals. This decentralized approach has been found to contribute to variations in biosimilar uptake across countries, and even within countries, as was investigated for tumour necrosis factor-alfa (TNF-α) inhibitor biosimilars in Sweden [1, 2]. In Germany, biosimilar market shares are also known to vary at the regional level. This was studied by Blankart et al. for erythropoiesis-stimulating substances, filgrastim and somatropin, and variations in biosimilar market shares were partly attributed to the presence of explicit regional cost-control measures, such as quota regulations [3]. Differences in the uptake of biosimilars have also been described in Germany for the class of TNF-α inhibitors, although reasons behind this variable uptake have not been examined in detail [4].

Positive phase III results for sintilimab plus copy biological Byvasda

Biosimilars/Research | Posted 15/01/2021

Chinese biopharmaceutical firm Innovent Biologics (Innovent) announced on 23 November 2020 positive results for its copy bevacizumab biological Byvasda (IBI-305) in combination with sintilimab.

More national guidance needed on biosimilars in Europe

Biosimilars/Research | Posted 08/01/2021

A poster presented at the Virtual ISPOR (International Society for Pharmacoeconomics and Outcomes Research) 2020 conference outlines the importance of regulatory guidance on biosimilar medicines in Europe.

Phase I study comparing SB8 with reference bevacizumab

Biosimilars/Research | Posted 08/01/2021

SB8, developed by Samsung Bioepis, was approved as a biosimilar of the reference product Avastin (bevacizumab) by the European Commission in August 2020 with the brand name of Aybintio [1]. The objective of this phase I study was to compare the pharmacokinetics, safety, tolerability and immunogenicity between SB8 and the European Union (EU) and United States (US) reference products (bevacizumab-EU and bevacizumab-US).

Scientific, legal and regulatory challenges facing biosimilars development

Biosimilars/Research | Posted 11/12/2020

Abbreviated approval pathways for biosimilars – biological products that are highly similar to an originator biological with regard to quality, safety and efficacy [1, 2] – were created to foster competition and lower prices for biological treatments. However, these desired effects have not materialized as quickly as expected in either the US or the European Union.

Safety monitoring for immune-modulating biologicals

Biosimilars/Research | Posted 11/12/2020

A study of adverse events among patients with autoimmune disease identifies numerous cases of serious infection. The study also demonstrates the ability of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) to function as a surveillance platform [1].

Real-world data on biosimilars in inflammatory arthritis treatment

Biosimilars/Research | Posted 04/12/2020

The use of biologicals in patients with rheumatic diseases has achieved the therapeutic target, i.e. remission or low disease activity. The share of biologicals has been growing with the approval of biosimilars, which have been recognized for their equivalent efficacy, safety, pharmacokinetics and immunogenicity to the originator, as well as their reduced economic burden.

Study reveals wide variation in US state drug product substitution laws

Biosimilars/Research | Posted 04/12/2020

A new study, published in JAMA Internal Medicine [1], has revealed substantial variation in the drug product substitution rules for pharmacists across states in the US.

Asia Pacific countries: future demand for biosimilars

Biosimilars/Research | Posted 27/11/2020

The prevalence of chronic diseases like diabetes, cancer and rheumatoid arthritis have been increasing globally, resulting in an ever-growing need for biologicals that are affordable and accessible in the Asia Pacific countries (APAC). Biosimilars are ‘similar’ versions of approved and authorized biological medicines that are already on the market. They typically sell at discounts ranging from 20% to 35% when compared to the reference product [1]. It is expected that introduction of biosimilars into the global markets will erode the total sales of biologicals by as much as 54% through 2022 [2]. Various regulatory bodies such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the World Health Organization (WHO) actively regulate development and commercialization of biosimilars.

Biopharmaceuticals and biosimilars: regulatory challenges for global harmonization of GMP standards

Biosimilars/Research | Posted 27/11/2020

A recent GaBI Journal [1] article by Sia et al. has explored biopharmaceutical good manufacturing practice (GMP) standards around the globe. The authors uncovered the challenges faced in attempting to achieve global harmonization of biopharmaceutical GMP standards.

Discontinuation following biosimilar switching in IBD patients

Biosimilars/Research | Posted 20/11/2020

Medical management of inflammatory bowel diseases (IBD) has significantly improved since the introduction of biological therapies over the past 20 years. The adoption of biologicals in IBD care has led to an exponential increase in treatment-related costs, resulting in a huge economic impact. As the patents of older biologicals expire, the interest in marketing comparable versions of the reference products increases, enabling opportunities for the development of similar biological products. Biosimilars have the potential to expand access to biological therapies due to price competition and cost savings [1].

Global harmonization of GMP standards for biologicals

Biosimilars/Research | Posted 20/11/2020

Biopharmaceuticals are complex as their active pharmaceutical ingredient (API) is manufactured using living systems. In turn, this leads to complex manufacturing processes. A recent GaBI Journal [1] article by Sia et al. has investigated the good manufacturing practice (GMP) standards of various global regulatory authorities (RAs) and international organisations (IOs). It has revealed that we are well on the way to global harmonization of GMP standards that will help bring these products to more people across the globe.

A blueprint for biosimilar assessment without efficacy trials

Biosimilars/Research | Posted 13/11/2020

Comparative efficacy trials have played an important role in biosimilarity assessments. However, with recent technological advances, their role is now being questioned. Research published in Drug Discovery Today [1] outlines the reasons why biosimilar assessments can now be carried out without these trials [2, 3]. It also lays out the requirements for prospective applications without efficacy trials.

Copy biological approvals in China, compared to the US and EU

Biosimilars/Research | Posted 13/11/2020

A review of copy biological approvals in China finds that 75% of approved monoclonal antibodies, fusion proteins and granulocyte colony-stimulating factor (G-CSF) copy biologicals have been successfully commercialized in the country [1].

Rationale for biosimilar assessment without efficacy trials

Biosimilars/Research | Posted 06/11/2020

An article published in Drug Discovery Today explores the necessity of the clinical efficacy trial in biosimilarity assessments [1].