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.

Regulatory challenges with biosimilars

Biosimilars/Research | Posted 08/01/2021

The World Health Organization (WHO) Expert Committee on Biological Standardization adopted guidelines for biosimilars at its 60th meeting in October 2009 [1]. Since then, according to authors from regulatory bodies across the globe, WHO ‘has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices’.

China approves adalimumab copy biological HLX03

Biosimilars/News | Posted 08/01/2021

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 7 December 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its adalimumab copy biological HLX03.

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.

EMA and FDA accept application for adalimumab biosimilar AVT02

Biosimilars/News | Posted 08/01/2021

Iceland-based biopharmaceutical company Alvotech announced on 19 November 2020 that its US subsidiary, Alvotech USA, had filed an application for its adalimumab biosimilar (AVT02). The company also announced that the European Medicines Agency (EMA) had accepted for review its application for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.

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).

Biosimilars in Australia – a-flagging and sustainability

Biosimilars/General | Posted 08/01/2021

Australia first introduced guidelines for biosimilars back in August 2008 when it adopted a number of guidelines from the EU on similar biological medicinal products [1].

EMA recommends approval of bevacizumab biosimilar Onbevzi

Biosimilars/News | Posted 11/12/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 November 2020 that it had recommended granting marketing authorization for the bevacizumab biosimilar Onbevzi.

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].

Biosimilar advances for Samsung Bioepis

Biosimilars/General | Posted 11/12/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has announced several advances related to its infliximab, denosumab and ranibizumab biosimilars. These announcements come after the company revealed soaring sales figure in Europe.

EMA accepts application for bevacizumab biosimilar BAT1706

Biosimilars/News | Posted 04/12/2020

China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced on 25 November 2020 that it had submitted an application for its proposed bevacizumab biosimilar, BAT1706, to the European Medicines Agency (EMA).

Australia approves etanercept and insulin aspart biosimilars

Biosimilars/News | Posted 04/12/2020

Australia’s drug regulator, the Therapeutic Goods Administration (TGA), announced in October 2020 the approval of etanercept and insulin aspart biosimilars.

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.

Genentech sues Centus over Avastin biosimilar

Biosimilars/General | Posted 04/12/2020

Genentech Inc. filed a complaint against Centus in the United States (US) state of Texas on 15 November 2020. It is alleged that Centus’s Equidacent, a biosimilar to Genentech’s Avastin (bevacizumab), infringes 10 US patents.

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.

FDA accepts application for ranibizumab biosimilar

Biosimilars/News | Posted 27/11/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) and partner US biotechnology company Biogen announced on 18 November 2020 that the US Food and Drug Administration (FDA) had accepted the application for their proposed ranibizumab biosimilar (SB11).

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.

Biosimilar toolkit for cancer patients

Biosimilars/General | Posted 27/11/2020

The European Cancer Patient Coalition (ECPC) has launched a biosimilars e-module, or toolkit [1]. This aims to teach patients about the value 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.

Canada approves enoxaparin biosimilars Inclunox and Noromby

Biosimilars/News | Posted 20/11/2020

Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Inclunox and Noromby.

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].

Alberta Biosimilars Initiative: switching policy updates in Canada

Biosimilars/General | Posted 20/11/2020

The Alberta government in Canada has announced updates to the Alberta Biosimilars Initiative.

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.

Biosimilar advances for Celltrion Healthcare

Biosimilars/General | Posted 13/11/2020

South Korea-based biotechnology company Celltrion Healthcare announced advances related to their infliximab, omalizumab and adalimumab biosimilars.

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].

GBMA publishes information resources on biosimilars for consumers and carers

Biosimilars/General | Posted 13/11/2020

The Generic and Biosimilar Medicines Association (GBMA), the representative body of generic and biosimilar medicine suppliers in Australia, has recently published information resources for consumers and carers on biosimilars.

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].

Innovent and Eli Lilly receive approval for rituximab copy biological in China

Biosimilars/News | Posted 06/11/2020

Innovent Biologics and Eli Lilly have received joint marketing approval from the National Medical Products Administration (NMPA) in China for their rituximab copy biological, Halpryza.

Shared decision-making and the transition to biosimilars

Biosimilars/Research | Posted 06/11/2020

Increasing healthcare cost are forcing health authorities to look for low-cost innovations to help bend the cost curve. Biosimilars, a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biological, are such an innovation [1]. Because biosimilars are often offered at lower prices, their use has been promoted all across the world. The initiating of biosimilars in bio-naïve patients is already commonplace in many countries. However, the transitioning from originator biological to its biosimilar for non-medical reasons is still debated. Different strategies about how and when to transition are formulated and applied.

International Psoriasis Council releases consensus statement on biosimilars

Biosimilars/General | Posted 30/10/2020

The International Psoriasis Council (IPC) Biosimilar Working Group (BSWG) published their consensus statements for the use of biosimilars in the treatment of patients with psoriasis [1].

Canada approves trastuzumab biosimilar Kanjinti

Biosimilars/News | Posted 30/10/2020

Canada’s medicines regulator, Health Canada, has approved the trastuzumab biosimilar Kanjinti by Amgen. This marks the second trastuzumab biosimilar to be approved by Health Canada.

Role of efficacy trials in biosimilar assessments questioned

Biosimilars/Research | Posted 30/10/2020

In recent years, the role of the comparative efficacy trial in biosimilar assessments has been brought into question. This is explored in a recent article published by Bielsky and colleagues [1].

Perceptions of biosimilars and switching in Arab rheumatologists

Biosimilars/Research | Posted 30/10/2020

The introduction of biosimilars into the rheumatology field could lead to dramatic cost savings as has been observed in certain European countries. Their implementation and acquisition, however, is not the same across the world. Many rheumatologists have developed a negative perception toward biosimilars and the process of non-medical switching. As important stakeholders, their views and concerns need to be addressed to ensure an effective introduction of these therapeutic agents. Mohammed Omair and colleagues evaluated how Arab rheumatologists perceive biosimilars in view of understanding the manufacturing and approval process during the Arab League Against Rheumatism Conference (ArLAR) [1].

EMA accepts application for ranibizumab biosimilar from Samsung Bioepis

Biosimilars/News | Posted 23/10/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agency (EMA) has accepted to review its marketing authorization application for SB11, a biosimilar of Lucentis® (ranibizumab). If successful, this will be the first Lucentis® biosimilar available in Europe.

Biosimilar assessments: do we need efficacy trials?

Biosimilars/Research | Posted 23/10/2020

Regulatory guidelines for biosimilar approval have existed in Europe since 2004. These are based on the totality of evidence from comparative studies with reference products and have always required comparative efficacy studies. However, a recent article by Bielsky et al., published in Drug Discovery Today [1], explores the increasingly questioned role of the clinical efficacy trial in biosimilar approval.

Biopharmaceuticals and biosimilars: manufacturing challenges

Biosimilars/Research | Posted 23/10/2020

Biopharmaceuticals include a complex active pharmaceutical ingredient (API). This is manufactured using living systems such as microbial and mammalian cells which makes manufacture a complicated process. A recent paper by Sia et al. published in GaBI Journal [1] has explored current biopharmaceutical processes and the challenges posed by manufacturer.

Biopharmaceuticals and biosimilars: manufacturing processes

Biosimilars/Research | Posted 16/10/2020

The active pharmaceutical ingredient (API) in biopharmaceuticals is manufactured using living systems such as microbial and mammalian cells. Due to this, their manufacture is complex. A recent review by Sia et al. published in GaBI Journal [1] has carried out an in-depth exploration of current biopharmaceutical manufacturing processes.

EC approval for bevacizumab biosimilar Equidacent

Biosimilars/News | Posted 16/10/2020

Centus Biotherapeutics Ltd announced on 29 September 2020 that the European Commission (EC) granted marketing authorization for Equidacent, its Avastin (bevacizumab) biosimilar.

China accepts application for bevacizumab copy biological

Biosimilars/News | Posted 16/10/2020

The National Medical Products Administration (NMPA) in China has accepted an investigational new drug (IND) application for a bevacizumab copy biological developed by 3SBio and Samsung Bioepis.

Pharmacists are key to quality use of medicines for biosimilars

Biosimilars/Research | Posted 16/10/2020

A commissioned review in The Pharmaceutical Journal [1] on interchangeability of biosimilars highlights the pivotal role pharmacists play in the adoption and appropriate use of biosimilars.

Australian diabetes organizations issue biosimilars position statement

Biosimilars/General | Posted 16/10/2020

In June 2020, the Australian Diabetes Society, Australian Diabetes Educators Association and Diabetes Australia, published a position statement on the use of biosimilar ‘insulins’ for diabetes.

Clinical review of biosimilars approved in oncology

Biosimilars/Research | Posted 09/10/2020

As cancer therapeutics constitutes a large proportion of the biologicals market, and patents have begun to expire, biosimilars have an important role in optimizing patient access and reducing costs in the oncology therapeutic area. Authors Ngo and Chen from the City of Hope National Medical Center, Los Angeles, USA, give an overview of the US Food and Drug Administration (FDA)-approved biosimilars in oncology and their impact on the healthcare system in the Annals of Pharmacotherapy [1]. A summary of the main findings from that article follows.

Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP

Biosimilars/Research | Posted 09/10/2020

Biopharmaceuticals are large molecules that are far more complex than traditional, chemical pharmaceuticals. With patent expiry for many originators, biosimilar versions are expected to flood the market in the years to come. However, the active pharmaceutical ingredients (APIs) of all such products are manufactured using living systems which means that their manufacture and characterization is also complex.

China approves adalimumab copy biological Sulinno

Biosimilars/News | Posted 09/10/2020

China-based Innovent Biologics (Innovent) has received marketing authorization from the National Medical Products Administration (NMPA) for their adalimumab copy biological Sulinno.

Why biosimilar applications fail during regulatory evaluation?

Biosimilars/Research | Posted 02/10/2020

The patent expirations of many blockbuster biologicals have paved the way for development of biosimilars and this has the potential to enhance access to otherwise high-cost biological therapies. Given the complexity of biologicals, the regulatory guidelines for biosimilar approval are meticulous and different from generics. Hence biosimilar developers often face issues during the application evaluation by regulatory authorities. With large number of biosimilars in development stage, it is pertinent for a manufacturer to have a deep understanding of the regulatory approval process. Rathore and colleagues from the Indian Institute of Technology offer insights into the objections raised by the regulatory authorities during evaluation of biosimilar applications for marketing authorization with special emphasis on applications reviewed by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Spectroscopy remains dominant when investigating biosimilar structures

Biosimilars/Research | Posted 02/10/2020

Biopharmacological studies, including biosimilar studies, require investigation of the higher order structure of proteins. A recent review published in GaBI Journal (GABIJ) [1] has found that, although many analytical methods to determine the higher order structures exist, spectroscopic methods remain the most used.

Cadila launches two new similar biologics in India

Biosimilars/News | Posted 02/10/2020

Cadila Pharmaceuticals (Cadila) has launched two similar biologics onto the Indian market: NuPTH, a teriparatide similar biologic and Cadalimab, a similar biologic of the auto-immune treatment adalimumab. Cadila has launched four new products on the domestic market since July 2020.

Biocon and Celltrion make progress in the battle against COVID-19

Biosimilars/News | Posted 02/10/2020

Biocon has reported promising results from a clinical trial of its biosimilar itolizumab in patients hospitalised with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. Meanwhile, Celltrion Healthcare (Celltrion) is investigating the use of its infliximab biosimilar CT-P13 to treat patients with COVID-19 infection.

Sustainable market scorecard represents gold-standard for biosimilar sustainability

Biosimilars/General | Posted 02/10/2020

IQVIA Institute and Medicines for Europe have recently launched Country Scorecards for Biosimilar Sustainability in 12 European countries [1]. The scorecards assess the level of competition, price evolution and volume development for seven key biological molecules – adalimumab, etanercept, infliximab, insulin glargine, insulin lispro, rituximab and trastuzumab – in each country. They also present a sustainability assessment and detail positive policy elements, challenges and solutions for each country.

Phase III trial updates of Samsung Bioepis’ bevacizumab and aflibercept biosimilars

Biosimilars/Research | Posted 25/09/2020

Samsung Bioepis has reported positive results from a phase III trial of its bevacizumab biosimilar, Aybinto. The company is also initiating a phase III trial for its aflibercept biosimilar, SB15.

Indications expanded for Merck’s etanercept biosimilar Brenzys

Biosimilars/News | Posted 25/09/2020

The indications of Merck Canada’s etanercept biosimilar Brenzys have been expanded to include plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis.

FDA to investigate PD biomarkers to show biosimilarity

Biosimilars/Research | Posted 25/09/2020

The US Food and Drug Administration (US FDA) is conducting research on critical aspects of the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. A study published in Clinical Pharmacology and Therapeutics, has outlined how the agency hopes to inform their thinking on critical aspects of how these biomarkers can be used to reduce the need for comparative clinical studies [1]. In turn, this can reduce the time and cost of bringing a biosimilar product to market, giving faster access to affordable, safe, and effective treatments.

FDA updates Purple Book database

Biosimilars/General | Posted 25/09/2020

The US Food and Drug Administration (FDA) has updated its searchable Purple Book database to include allergenic, cellular and gene therapy, haematologic and vaccine products.

Insulin glargine biosimilar Semglee launched in US

Biosimilars/News | Posted 18/09/2020

The partnership of US-based drugmaker Mylan and Indian biologicals specialist Biocon announced on 31 August 2020 the launch of their insulin glargine product, Semglee, in the US.

Biosimilars allow fast access to biological drug therapy in Bavaria, Germany

Biosimilars/Research | Posted 18/09/2020

A new study has shown that patients suffering from rheumatism in Bavaria, Germany, are now likely to be prescribed a biological medicine much faster than five years ago. Results of the study were shared at the AG Pro Biosimilars digital symposium on 14 September 2020.

What oncologists do not understand about biosimilars

Biosimilars/Research | Posted 18/09/2020

The availability of biosimilars may improve access to health care by increasing the number of therapeutic options available at potentially lower costs. However, based on the results of multiple surveys of many healthcare providers (HCPs) conducted in recent years, clinicians appear wary of prescribing biosimilars.

Country scorecards show biosimilar sustainability

Biosimilars/General | Posted 18/09/2020

Biosimilars are an important component of sustainable health systems as they provide alternatives to originator biological products once those products no longer have market exclusivity. Europe has the world’s largest biosimilar market, accounting for approximately 60% of the global market. European countries therefore serve as valuable examples of successful approaches to biosimilar policy [1]. Nevertheless, across Europe, the level of competition among biosimilars differs widely by country and by molecule, as does the extent of their use and their impact on pricing. Much of this variability can be linked to differences in health system policy elements that contribute to sustainable market conditions for biosimilars.

Budget savings from biosimilar infliximab in the UK, France, Japan and Korea

Biosimilars/Research | Posted 11/09/2020

Biological medicines are attracting attention from policymakers and health insurers across countries due to their increased financial burden. The potential for biosimilars’ cost savings can be influenced by various factors, including supply-side (pricing policies) and demand-side (usage-enhancing) policies.

Samsung Bioepis launches Ontruzant in Brazil

Biosimilars/News | Posted 11/09/2020

South Korean biotechnology company Samsung Bioepis has announced the launch of their trastuzumab biosimilar Ontruzant in Brazil. The product was approved by the Brazilian health agency in May 2019.

Duopharma to establish Malaysia’s first commercial biosimilar facility

Biosimilars/General | Posted 11/09/2020

Malaysia-based manufacturer Duopharma Biotech aims to establish Malaysia’s first commercial biosimilar production facility. The company is also working to achieve halal certification for its erythropoietin biosimilar, Erysaa.

Cadila Pharmaceuticals launches two similar biologics in India

Biosimilars/News | Posted 11/09/2020

Indian generics maker Cadila Pharmaceuticals Ltd (Cadila) has launched two new similar biologics in the country: Bevaro (bevacizumab) and Ritucad (rituximab).

Celltrion’s biosimilars effective against gastric cancer and B-cell lymphoma

Biosimilars/Research | Posted 11/09/2020

Recent clinical trial results confirm that Celltrion’s biosimilars Herzuma (trastuzumab) and Truxima (rituximab) are effective in the treatment of gastric cancer and B-cell lymphoma, respectively.

EC approval for trastuzumab biosimilar Zercepac

Biosimilars/News | Posted 04/09/2020

The European Commission (EC) has granted marketing authorization for the trastuzumab biosimilar Zercepac (HLX02) on 27 July 2020. The product is produced by the Shanghai Henlius Biopharmaceutical Co Ltd (Henlius), making it the first China-made biosimilar to receive approval in Europe.

WHO prequalifies Celltrion’s trastuzumab biosimilar Herzuma

Biosimilars/General | Posted 04/09/2020

The World Health Organization (WHO) has prequalified Celltrion Healthcare’s second biosimilar, a trastuzumab biosimilar sold as Herzuma.

Monoclonal antibody biosimilars and cancer in the EU

Biosimilars/Research | Posted 04/09/2020

Spanish researchers investigated the current status of biosimilar monoclonal antibodies (mAbs) in the European Union (EU) by reviewing the regulatory pathway, the rationale for extrapolation and switching and the current status and future perspectives of the biosimilars approved in the EU [1].

The biosimilars market in Latin America: a summary

Biosimilars/Research | Posted 28/08/2020

A review of the biosimilars market in Latin America [1] finds that Argentina, Brazil and Mexico have the largest number of approved similar biotherapeutic products (SBPs), while information in other countries is more limited. The review recommends investment in biotechnology hubs and further development of regulation on biological drugs.

EMA recommends approval of bevacizumab biosimilar Equidacent

Biosimilars/News | Posted 28/08/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting of marketing authorization for the bevacizumab biosimilar Equidacent, which is produced by Centus Biotherapeutics, a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics

Clinical trials for trastuzumab biosimilars

Biosimilars/General | Posted 28/08/2020

Roche’s originator trastuzumab biological (Herceptin) was approved by the US Food and Drug Administration (FDA) in September 1998 and by the European Medicines Agency (EMA) in August 2000 [1]. The patents on Herceptin expired in Europe in July 2014 and in the US in June 2019 [1]. This has led to biosimilars of trastuzumab being developed.

Sustainable biosimilar policies in Europe

Biosimilars/Research | Posted 31/07/2020

A review of approaches to biosimilar policy in Europe [1] highlights key principles for a sustainable biosimilar market, including supporting innovation and allowing for multiple suppliers.

EC approval for Sanofi’s insulin aspart biosimilar

Biosimilars/News | Posted 31/07/2020

The European Commission (EC) has issued marketing authorization for Sanofi’s insulin aspart biosimilar, which references Novo Nordisk’s product NovoLog and is used to treat type 1 and 2 diabetes.

Biosimilar infliximab reduces medication costs by two thirds in Finland

Biosimilars/Research | Posted 31/07/2020

A study of 54 people with inflammatory bowel disease (IBD) in Finland showed that switching to biosimilar infliximab has no significant impact on health-related quality of life or disease activity, while reducing costs by two thirds [1].

Trastuzumab biosimilar Kanjinti is stable over extended storage periods

Biosimilars/Research | Posted 24/07/2020

An investigation of the quality and in-use stability of diluted trastuzumab biosimilar Kanjinti (also known as ABP 980) versus the reference trastuzumab demonstrated no clinically meaningful differences in stability and activity over extended storage periods, according to Crampton et al. [1].

EMA approves bevacizumab and teriparatide biosimilars

Biosimilars/News | Posted 24/07/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 June 2020 that it had recommended granting marketing authorization for the bevacizumab biosimilar Aybintio and for the teriparatide biosimilars Livogiva and Qutavina.

FDA approves pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 24/07/2020

Pharma giant Pfizer announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Nyvepria (HSP-130).

Biosimilar pipelines for Korean firms looking healthy

Biosimilars/General | Posted 24/07/2020

Korean companies are becoming more and important both in the country but also worldwide when it comes to developing biosimilars.

FDA approves Mylan’s adalimumab biosimilar Hulio

Biosimilars/News | Posted 17/07/2020

The US Food and Drug Administration (FDA) has approved Mylan/Fujifilm’s adalimumab biosimilar Hulio (adalimumab-fkjp) on 7 July 2020. The product is the sixth adalimumab biosimilar to be approved by FDA and is manufactured by Japan-based Fujifilm Kyowa Kirin Biologics.

Quotas improve biosimilar use in Germany

Biosimilars/Research | Posted 17/07/2020

An assessment of the role of cost control measures on biological drugs in Germany finds that quotas for biosimilars are in some cases associated with increased use and are overall more effective than priority prescribing [1].