Biosimilars

Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis

Biosimilars/General | Posted 04/06/2021

Biosimilars are becoming more important around the world and Korean companies, such as Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture), are fast becoming major players both in Korea but also worldwide.

Review and meta-analysis of biosimilars for the treatment of rheumatoid arthritis

Biosimilars/Research | Posted 04/06/2021

Authors from Japan provide a new perspective on biosimilars for management of rheumatoid arthritis (RA) to provide evidence of efficacy and safety of biosimilars compared with reference biological disease-modifying anti-rheumatic drugs (bDMARDs) (reference bDMARDs) in patients with RA as a part of the process of developing the 2020 update of the Japan College of Rheumatology (JCR) guidelines for the management of RA [1].

On the edge of transition: European biosimilar clinical trial requirements

Biosimilars/Research | Posted 31/05/2021

Recent debates have focused on the clinical trial requirements for biosimilar approval [1-4]. Further, the regulatory approval of biosimilars in the European Union (EU) has been changed, where in some instances and under certain conditions clinical trials to establish comparable efficacy have been excluded [4]. Still, the regulatory recommendation for more complex molecules such as monoclonal antibodies is without exception to conduct clinical comparability trials [4].

Canada approves five adalimumab biosimilars in last six months

Biosimilars/News | Posted 31/05/2021

Since October 2020, Canada’s drug regulator, Health Canada, has approved no less than five adalimumab biosimilars for the treatment of multiple chronic inflammatory diseases.

Biosimilar pipelines for South Korean firms: Chong Kun Dang, DM Bio and HK inno.N

Biosimilars/General | Posted 31/05/2021

South Korea is becoming a more and more important spot on the map when it comes to biosimilars. Although Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture) are leading the way in Korea and worldwide, other Korean companies, such as Chong Kun Dang Pharmaceutical (Chong Kun Dang), DM Bio (joint venture between Dong-A ST and Meiji Holdings) and HK inno.N (previously CJ Healthcare), are also expanding their biosimilar pipelines.

Are regulatory and scientific reporting biosimilar QAs consistent and complimentary?

Biosimilars/Research | Posted 21/05/2021

Questions have been raised regarding the consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities. For the first time, a study published in Biologicals [1] has found that while the reporting of quality attributes (QAs) by these two sources lacks consistency, overall, they do complement one another. 

Approved biosimilars for South Korean firms: Celltrion and Samsung Bioepis

Biosimilars/General | Posted 21/05/2021

Korean companies, such as Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture), are becoming more and more important both in the country and worldwide when it comes to developing biosimilars.

Australia approves adalimumab biosimilar Abrilada

Biosimilars/News | Posted 21/05/2021

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA), has approved the adalimumab biosimilar Abrilada (PF-06410293).

Role of European patient associations when informing patients about biosimilars

Biosimilars/Research | Posted 21/05/2021

Biosimilars contribute to more sustainable healthcare systems by generating competition in the off-patent biologicals market. The extent to which the benefits of competition in the marketplace are exploited depends, of course, on their use in clinical practice. One of the factors determining adoption in clinical practice is the acceptance by healthcare providers (HCP) and patients. Often, a lack of acceptance comes down to shortcomings in knowledge and understanding about biosimilars. Educating patients about biosimilars is therefore considered as one of the key elements for a successful market for off-patent biologicals and biosimilars.

EC approves bevacizumab biosimilar Abevmy

Biosimilars/News | Posted 14/05/2021

On 26 April 2021, India-based biologicals specialist Biocon Biologics (Biocon) announced that its bevacizumab biosimilar, Abevmy (MYL 1402O), which it co-developed with US-based drugmaker Viatris (formerly Mylan), had received European Commission (EC) approval.

Canadian provinces expand their use of biosimilars

Biosimilars/General | Posted 14/05/2021

New Brunswick has become the third Canadian province to implement a biosimilar switching policy. The province of Alberta has also expanded its switching programme to include biosimilars of the anti-inflammatory treatment adalimumab (Humira). 

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. 

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].

Safety of switching between rituximab biosimilars in cancer

Biosimilars/General | Posted 07/05/2021

In more than 10 years of clinical experience, no substantial clinical and safety differences have been detected among biosimilars and their already approved biologicals [1]. However, concerns are raised with respect to the practice of switching in patients already treated with a specific biological product (either reference or biosimilar) [2].

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.

Samsung Bioepis launches Hadlima in Australia and Canada

Biosimilars/News | Posted 07/05/2021

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 29 March 2021 that it had now launched its adalimumab biosimilar, Hadlima (SB5), in Australia and Canada.

Insurer formularies increase complexity for healthcare providers

Biosimilars/General | Posted 07/05/2021

An assessment of insurer formularies for pegfilgrastim in the US suggests that payer-imposed preferences increase complexity when pharmacists and physicians are choosing which version of a drug to stock and administer.  

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].

LG Chem gains approval for adalimumab biosimilar in Japan

Biosimilars/News | Posted 30/04/2021

Japan-based LG Chem (formerly LG Life Sciences) announced on 23 March 2021 in a public filing that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for 20 mg, 40 mg and 80 mg syringe, and 40 mg pen formulations of its adalimumab biosimilar, Adalimumab BS MA (LBAL).

Rheumatoid arthritis treatments in Australia

Biosimilars/General | Posted 30/04/2021

Analysis of the treatment landscape for rheumatoid arthritis in Australia shows that AbbVie’s Humira (adalimumab) and Pfizer’s Enbrel (etanercept) together make up half of total sales.

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.

EC approval for bevacizumab biosimilar Alymsys/Oyavas

Biosimilars/News | Posted 23/04/2021

The European Commission (EC) granted marketing authorization for the bevacizumab biosimilar Alymsys/Oyavas (MB02), on 31 March 2021. The biosimilar is developed by mAbxience, a biopharmaceutical firm with offices in Spain, Argentina and Switzerland.

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.

Biosimilars of enoxaparin sodium

Biosimilars/General | Posted 23/04/2021

Enoxaparin sodium is an anticoagulant medication (blood thinner). It is used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. It is also used in those with acute coronary syndrome (ACS) and heart attacks.

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].

British Columbia adds adalimumab to biosimilar switching programme

Biosimilars/General | Posted 16/04/2021

British Columbia (BC), the first province in Canada to switch patients to biosimilar drugs, has added adalimumab to its switching programme. Almost 6,000 patients will be transitioned from originator adalimumab (Humira) to one of five biosimilar versions.

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.

Advances for Formycon and Alteogen’s eye disease biosimilar candidates

Biosimilars/News | Posted 16/04/2021

In March 2021, Formycon confirmed the resubmission strategy for their Lucentis® (ranibizumab) biosimilar candidate (FYB2010) in the US. In addition, Alteogen announced the completion of its phase I clinical trial of Eylea® (aflibercept) biosimilar (ALT-L9). Both of these biological drugs are used to treat conditions leading to the loss of vision.

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.

FDA accepts application for adalimumab biosimilar CHS-1420

Biosimilars/News | Posted 09/04/2021

US-based Coherus BioSciences (Coherus) announced on 17 February 2021 that the US Food and Drug Administration (FDA) had accepted the application for their proposed adalimumab biosimilar CHS-1420.

Biosimilars of ustekinumab

Biosimilars/General | Posted 09/04/2021

Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.

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.

Australian and Indian approval for teriparatide products

Biosimilars/News | Posted 02/04/2021

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has approved a teriparatide biosimilar and the Drug Controller General of India (DCGI) has approved a teriparatide ‘similar biologic’.

Biosimilars of aflibercept

Biosimilars/General | Posted 02/04/2021

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema.

Biosimilars in Europe: prescriber survey

Biosimilars/Research | Posted 26/03/2021

A survey of European prescribers reveals a significant increase in familiarity with biosimilars since 2013 [1]. In addition, prescribers increasingly believe they should always have control of treatment decisions, including those to switch to a biosimilar.

Argentina approves bevacizumab similar biological medicine Zutrab

Biosimilars/News | Posted 26/03/2021

The Argentina-based Richmond Laboratory (Laboratorios Richmond) announced on 19 March 2021 that it had gained approval from Argentina’s National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) for its similar biological medicine (medicamento biológico similar) Zutrab (bevacizumab).

EC approval for insulin aspart biosimilar Kixelle

Biosimilars/News | Posted 26/03/2021

The European Commission (EC) has granted marketing authorization for the insulin aspart biosimilar Kixelle (MYL 1601D), developed by US-based drugmaker Mylan (now Viatris) and India-based biologicals specialist Biocon.

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].

IVM releases toolbox on how to switch patients to insulin biosimilars

Biosimilars/General | Posted 19/03/2021

The Dutch Instituut voor Verantwoord Medicijngebruik (Institute for Responsible Medicines Use, IVM) has released a toolbox for healthcare providers on how to switch patients to insulin biosimilars.

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.

EC approves adalimumab biosimilar Yuflyma

Biosimilars/News | Posted 19/03/2021

On 15 February 2021, South Korea-based biotechnology company Celltrion Healthcare (Celltrion) announced that its adalimumab biosimilar, Yuflyma (CT P17), had received European Commission (EC) approval.

Approaches to naming and labelling of biosimilars

Biosimilars/Research | Posted 12/03/2021

Naming and labelling of biosimilars has been a controversial issue and there is a long-standing debate regarding the naming of biologicals.

EMA recommends approval of four bevacizumab biosimilars

Biosimilars/News | Posted 12/03/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 29 January 2021 that it had recommended granting marketing authorization for the bevacizumab biosimilars Alymsys and Oyavas. Then on 26 February 2021, the agency announced that it had recommended approval of the bevacizumab biosimilars Abevmy and Lextemy.

China accepts IND application for daratumumab copy biological HLX15

Biosimilars/News | Posted 12/03/2021

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 13 January 2021 that the investigational new drug (IND) application for its daratumumab copy biological, HLX15, had been accepted by China’s drug regulator, the National Medical Products Administration (NMPA), allowing it to carry out clinical trials in the country.

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.

Different approaches to the interchangeability of biosimilars

Biosimilars/Research | Posted 05/03/2021

The interchangeability of biosimilars can sometimes be an emotive subject. Despite reservations by prescribers, payers and patients, many countries have implemented policies allowing for the substitution of biologicals with biosimilars. However, there is still a lack of harmonization around the world when it comes to how different countries or regions approach the interchangeability of biosimilars [1].

Latest launches for adalimumab biosimilars in Canada and Japan

Biosimilars/News | Posted 05/03/2021

There has been a lot of news recently when it comes to adalimumab biosimilars. Sandoz, Fresenius Kabi, Fujifilm Kyowa Kirin Biologics/Mylan and Viatris have all announced launches of adalimumab biosimilars.

Biosimilar patent litigation trends in the US

Biosimilars/General | Posted 05/03/2021

According to authors from Law360 the trend in biosimilar patent litigation cases has been downward, with many cases being resolved and only five cases still pending as of 31 December 2020 [1].

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.

Collaboration between regulatory authorities for biosimilars

Biosimilars/Research | Posted 26/02/2021

A survey carried out by the World Health Organization (WHO) in 2019‒2020 highlighted the need for collaboration between regulatory authorities in order to expediate the approval of biosimilars [1].

Biosimilar approvals and launches in the US

Biosimilars/General | Posted 26/02/2021

An examination of biosimilar approvals by the US Food and Drug Administration (FDA) compared to launches was carried out by authors from Law360 [1].

FDA accepts application for bevacizumab biosimilar BAT1706

Biosimilars/News | Posted 26/02/2021

China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced on 28 January 2021 that the US Food and Drug Administration (FDA) had accepted the Biologics License Application (BLA) for its proposed bevacizumab biosimilar, BAT1706.

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.

Canada approves infliximab biosimilar Remsima SC

Biosimilars/News | Posted 19/02/2021

Canada’s drug regulator, Health Canada, has approved the infliximab biosimilar Remsima SC for the treatment of autoimmune diseases.

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.

Innovent starts phase II trial for ipilimumab copy biological

Biosimilars/News | Posted 19/02/2021

China-based Innovent Biologics (Innovent) announced on 11 December 2020 that the first patient had been successfully enrolled and dosed in the randomized, double-blind, phase II multicentre clinical trial (NCT04590599) evaluating its ipilimumab copy biological (IBI310) in combination with TYVYT (sintilimab) for the treatment of patients with second-line or above advanced cervical cancer.

Biosimilar approvals and patent litigation in the US

Biosimilars/General | Posted 19/02/2021

Authors from Law360 have examined biosimilar approvals by the US Food and Drug Administration (FDA) under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and ensuing patent litigation actions. They also discuss why the lack of new approvals and litigation in 2020 does not suggest reduced interest in biosimilars but signals a new wave of biosimilars on the horizon [1].

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].

EMA recommends approval of adalimumab biosimilar Yuflyma

Biosimilars/News | Posted 12/02/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting of marketing authorization for an adalimumab biosimilar.

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].

Canada approves insulin aspart biosimilar Trurapi

Biosimilars/News | Posted 12/02/2021

Canada’s drug regulator, Health Canada, has approved the insulin aspart biosimilar Trurapi.

Regulatory issues related to quality of biosimilars

Biosimilars/Research | Posted 05/02/2021

The quality of biosimilars was one of the challenges identified from the results of a survey carried out by the World Health Organization (WHO) [1]. The survey, which was carried out in 2019‒2020, revealed that despite the efforts of WHO in helping Member States implement the evaluation principles in the WHO biosimilar guidelines [2] into their regulatory practices, challenges still remain.

China extends indications for adalimumab and bevacizumab copy biologicals

Biosimilars/News | Posted 05/02/2021

Chinese biopharmaceutical firm Innovent Biologics (Innovent) announced that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved new indications for its adalimumab and bevacizumab copy biologicals.

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.

Canada approves three teriparatide biosimilars in 2020

Biosimilars/News | Posted 05/02/2021

Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Apo-teriparatide, Teva-teriparatide and Osnuvo.

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].

EMA recommends approval of insulin aspart biosimilar Kixelle

Biosimilars/News | Posted 29/01/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting of marketing authorization for an insulin aspart biosimilar.

FDA approves rituximab biosimilar Riabni

Biosimilars/News | Posted 29/01/2021

US-based biotech giant Amgen announced on 17 December 2020 that it had received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar Riabni (ABP 798).

Biosimilars and lack of resources

Biosimilars/Research | Posted 22/01/2021

The results of a survey carried out by the World Health Organization (WHO) in 2019‒2020 [1] revealed that, despite the efforts of the organization in helping Member States implement the evaluation principles in the WHO biosimilar guidelines [2] into their regulatory practices, challenges still remain. Lack of resources was one of the challenges identified from the results of the survey.

EMA recommends approval of adalimumab and insulin aspart biosimilars

Biosimilars/News | Posted 22/01/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting marketing authorization for the adalimumab biosimilar Yuflyma and for the insulin aspart biosimilar Kixelle.

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.

Canada approves heparin biosimilars Redesca and Redesca HP

Biosimilars/News | Posted 22/01/2021

Canadian pharmaceuticals firm Valeo Pharma (Valeo) announced on 9 December 2020 that Canada’s drug regulator, Health Canada, had approved its low molecular weight heparin (LMWH) biosimilars Redesca and Redesca HP.

Samsung biosimilars: denosumab clinical trials begin, while rituximab development is halted

Biosimilars/General | Posted 22/01/2021

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has initiated phase III trials for its denosumab biosimilar, while development on a rituximab biosimilar through subsidiary company Archigen Biotech has been stopped.

Biosimilars and availability of reference products

Biosimilars/Research | Posted 15/01/2021

A survey was carried out by the World Health Organization (WHO) in 2019‒2020 covering most current topics pertinent to biosimilars [1].

Biosimilars applications under review by EMA – January 2021

Biosimilars/General | Posted 15/01/2021

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

EC approval for pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 15/01/2021

The European Commission (EC) has granted marketing authorization for the pegfilgrastim biosimilar Nyvepria (PF-06881894), developed by US-based drugmaker Pfizer and its subsidiary Hospira.