Biosimilars

Safety of switching between reference products and biosimilars

Biosimilars/Research | Posted 29/05/2020

The safety of switching a patient under chronic treatment with a reference biological to a biosimilar has been a topic of ongoing debate since the first biosimilar approval in Europe in 2006. The topic sparked further discussion with the arrival of the more complex monoclonal antibody biosimilars. Concerns have been raised that switching between highly similar but non-identical versions of a biological medicine might lead to increased immunogenicity and as such, impact treatment outcomes. The existing stakeholder uncertainty regarding the safety of switching may have been curbing the use of biosimilars in clinical practice and guidance to support healthcare professionals with clinical decision-making is needed.

Amgen explains the steps of manufacturing a biosimilar

Biosimilars/General | Posted 29/05/2020

US-based biotech giant Amgen explains on its websites the steps involved in manufacturing a biosimilar.

Hepatobiliary events similar for SB4 and Enbrel in IJD

Biosimilars/Research | Posted 29/05/2020

According to a study carried out by researchers from Denmark, hepatobiliary adverse events occur at a similar frequency in patients treated with the etanercept biosimilar Benepali (SB4) compared to the originator product, Enbrel, in inflammatory joint disease (IJD) [1].

EU approves Henlius copy biologicals facility in China

Biosimilars/General | Posted 29/05/2020

Following European Union (EU) inspections of Shanghai Henlius Biotech, Inc’s Xuhui facility in China, it is likely that the copy biologicals produced at the site will soon be available internationally.

Trials of ustekinumab biosimilars advance

Biosimilars/News | Posted 29/05/2020

Japan-based Meiji Seika Pharma, together with the South Korean company Dong-A, have begun a phase I trial for their ustekinumab biosimilar. Meanwhile, the Australian firm NeuClone has reported results from the phase I trial of its ustekinumab biosimilar, NeuLara.

Do patent strategies delay market entry of biosimilar monoclonal antibodies in Europe?

Biosimilars/Research | Posted 22/05/2020

Patents have been shown to be the main determinant to guarantee market exclusivity of originator biologicals [1], with patent disputes causing uncertainty on a patent’s validity and subsequently potentially influencing launch dates of competitor products, such as biosimilars [2]. In addition, the launch date of a biosimilar might be affected by strategies for prolongation of exclusivity rights on the originator product, such as filing additional patents for a new formulation, new indication or new dosage regime [3].

Canada approves rituximab biosimilars Riximyo and Ruxience

Biosimilars/News | Posted 22/05/2020

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilars Riximyo (GP2013) and Ruxience (PF-05280586) for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

Reimbursement of biosimilars in the US

Biosimilars/General | Posted 22/05/2020

Barriers to market uptake of biosimilars in the US include biosimilars pricing, legal and promotional wars being waged by originator companies, and the lack of confidence in biosimilars [1, 2].

Amgen on both sides of the biosimilar arena

Biosimilars/General | Posted 22/05/2020

Amgen has both originator biologicals and also biosimilars in its portfolio, which means the US-based drugmaker can be on both sides of the fence when it comes to biosimilars.

EMA recommends approval of Sanofi’s insulin aspart biosimilar

Biosimilars/News | Posted 15/05/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 30 April 2020 that it had recommended granting of marketing authorization for an insulin aspart biosimilar.

Scientific evidence in development of trastuzumab biosimilar ABP 980

Biosimilars/Research | Posted 15/05/2020

ABP 980 (Kanjinti) is a biosimilar to trastuzumab reference product (RP) (Herceptin), a monoclonal antibody directed against human epidermal growth factor receptor 2 (HER2). A biosimilar is highly similar to a licensed biological with no clinically meaningful differences in safety, purity and potency [1, 2]. Kanjinti is approved in the US, European Union, and as trastuzumab BS [trastuzumab biosimilar 2] in Japan for all Herceptin indications, which include treatment of HER2 positive (HER2+) metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer [3-5]. Development and approval were based on a totality of evidence (TOE) approach, involving stepwise generation of comparative analytical (structural and functional), preclinical, and clinical (pharmacokinetics [PK], pharmacodynamics [PD], efficacy, safety and immunogenicity) evidence [6].

Biosimilar education gaps in oncology

Biosimilars/Research | Posted 15/05/2020

A survey administered by the International Society of Oncology Pharmacy Practitioners (ISOPP) identifies key educational needs on biosimilars amongst its practitioners, including how to compare a biosimilar to an originator and how to manage switching [1].

US FDA clears Biocon manufacturing sites in Malaysia and India

Biosimilars/General | Posted 15/05/2020

There has been successful closure of US Food and Drug Administration (FDA) inspections at Biocon Biologics sites in Malaysia and India. Three manufacturing sites were issued FDA establishment inspection reports (EIRs) in April 2020. The site in Malaysia is set to produce insulin glargine biosimilar, and two sites in Bangalore, India are set to manufacture trastuzumab and pegfilgrastim oncology biosimilars.

Pegfilgrastim biosimilar Fulphila launched in Canada

Biosimilars/News | Posted 08/05/2020

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country.

How to make biological drugs more affordable

Biosimilars/Research | Posted 08/05/2020

Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [1].

Online education for diabetes specialists on biosimilar insulins

Biosimilars/General | Posted 08/05/2020

An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.

Celltrion files application with EMA for adalimumab biosimilar

Biosimilars/News | Posted 08/05/2020

Celltrion has submitted an application to the European Medicines Agency (EMA) for its adalimumab biosimilar, currently known as CT-P17.

Non-innovator biologicals in India: regulatory context and areas for improvement

Biosimilars/Research | Posted 04/05/2020

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

Biocon/Mylan launch pegfilgrastim biosimilar Fulphila in Australia

Biosimilars/News | Posted 04/05/2020

US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

New information on biosimilars from Australia and the US

Biosimilars/General | Posted 04/05/2020

The Generic Biosimilar Medicines Association and the Biologics Prescriber Collaborative have released new information on biosimilars, aimed at physicians and the public, respectively.

Clinical trials for adalimumab biosimilar SB5

Biosimilars/Research | Posted 04/05/2020

The clinical trials used to support the approval of Samsung Bioepis/Merck’s adalimumab biosimilar SB5 (Imraldi/Hadlima), were critically reviewed by authors from Argentina and the UK, with a special focus on rheumatoid arthritis (RA) [1].

Merck launches trastuzumab biosimilar in the US

Biosimilars/News | Posted 24/04/2020

US pharma giant Merck (known as MSD outside the US and Canada) and Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced in on 15 April 2020 that they had launched their trastuzumab biosimilar, Ontruzant, in the US.

Assessment of biosimilarity for monoclonal antibodies

Biosimilars/Research | Posted 24/04/2020

How therapeutic monoclonal antibody biosimilars are assessed for biosimilarity, was discussed by authors from the National Institute of Health Sciences and the Yokohama University of Pharmacy in Japan. Their review covers the basic concept of biosimilar development as well as pharmacokinetic data obtained via non-clinical and clinical studies of biosimilar therapeutic antibodies [1].

FDA releases new information on interchangeable biologicals

Biosimilars/General | Posted 24/04/2020

The US Food and Drug Administration (FDA) has released new information on its website, clarifying the difference between biosimilars and interchangeable biologicals and says it will make more treatment options available to more people.

EC approval for rituximab biosimilar Ruxience

Biosimilars/News | Posted 24/04/2020

On 2 April 2020, pharma giant Pfizer announced that its rituximab biosimilar, Ruxience (PF‑05280586), had received European Commission (EC) approval.

Amgevita approved in Colombia

Biosimilars/News | Posted 17/04/2020

Colombia’s National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos) has approved the first adalimumab producto bioterapéutico similar (similar biotherapeutic product).

Biosimilars highlights: 2019

Biosimilars/General | Posted 17/04/2020

There were many biosimilars approved in 2019, as well as new clinical trials, research into issues surrounding biosimilar use, and significant regulatory changes [1], as summarized below.

Mabion withdraws application for rituximab biosimilar in EU

Biosimilars/News | Posted 17/04/2020

Polish biologicals company Mabion Spolka Akcyjna (Mabion) has withdrawn its duplicate applications for its rituximab biosimilar, MabionCD20.

British Columbia releases latest data on biosimilar switches

Biosimilars/General | Posted 17/04/2020

The latest data on biosimilar switching in British Columbia, Canada shows that 28% of patients with inflammatory bowel disease (IBD) have switched to a biosimilar version of their medication.

Clinical trials for adalimumab biosimilar BI 695501

Biosimilars/Research | Posted 17/04/2020

The clinical trials, especially those in rheumatoid arthritis, used to support the approval of Boehringer Ingelheim’s BI 695501 (Cyltezo), were critically reviewed by authors from Argentina and the UK [1].

Clinical trials for adalimumab biosimilar ABP 501

Biosimilars/Research | Posted 10/04/2020

The clinical trials used to support the approval of Amgen’s ABP 501 (Amjevita/Amgevita/
Solymbic) were critically reviewed by authors from Argentina and the UK [1].

Non-originator biologicals approved in Bosnia and Herzegovina

Biosimilars/News | Posted 10/04/2020

Russian biotechnology company Biocad announced on 30 March 2020 that it had received approval for two of its anticancer non-originator biologicals in Bosnia and Herzegovina.

Biocure developing five candidate biosimilars

Biosimilars/General | Posted 10/04/2020

South Korea’s pharmaceutical industry has fast been expanding as a world player. According to the Korea Health Industry Development Institute, the Korean pharmaceutical industry in 2018 represented 1.8% of the world market, i.e. the 13th largest in the world.

Positive phase III results for Hisun’s adalimumab copy biological

Biosimilars/Research | Posted 10/04/2020

Positive results were reported from a phase III trial of an adalimumab copy biological, HS016, which compared the candidate adalimumab copy biological HS016 with originator adalimumab Humira for the treatment of active ankylosing spondylitis (AS) [1].

Biosimilars and the safe harbor provision

Biosimilars/General | Posted 10/04/2020

In the US, the safe harbor provision exempts drug development and approval from patent infringement provisions, and courts have interpreted the safe harbor to apply broadly to Food and Drug Administration (FDA) regulated and approved products, including biologicals. However, courts have continued to struggle with the application of the safe harbor to different types of FDA submissions as the regulatory process has become more complex – and largely have continued to expand its scope.

EMA recommends approval of etanercept biosimilar Nepexto

Biosimilars/News | Posted 03/04/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 March 2020 that it had recommended granting of marketing authorization for a biosimilar etanercept product.

Access to biosimilars in China, the EU and the US

Biosimilars/General | Posted 03/04/2020

Access to more affordable treatments is the main driver for the approval of biosimilars. But how does this accessibility vary between Europe, the US and China?

Clinical trials supporting the approval of adalimumab biosimilars

Biosimilars/Research | Posted 03/04/2020

Authors from Argentina and the UK critically review the evidence from trials of biosimilars in rheumatoid arthritis (RA) [1].

The Patients Association publishes new advice on switching to biosimilars

Biosimilars/General | Posted 03/04/2020

Patient advocacy group in the UK, The Patients Association, has published new information and an animated video about switching to biosimilars.

Use of anti-TNF biosimilars in the US

Biosimilars/Research | Posted 03/04/2020

Uptake of biosimilars in the US is slow to say the least. In fact, biosimilars currently make up only 2.3% of the US biologicals marketplace [1]. Researchers from the US therefore investigated whether anti-tumour necrosis factor (anti-TNF) biosimilars are realizing their promise to increase competition and improve accessibility in the US [2].