Biosimilars

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Polish biologicals company Mabion Spolka Akcyjna (Mabion) has withdrawn its duplicate applications for its rituximab biosimilar, MabionCD20.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

Cost savings from the use of biosimilars in Canada

Biosimilars/Research | Posted 27/03/2020

Analysis of the potential cost savings from the use of three biosimilars (filgrastim, infliximab and insulin glargine) in Canada shows that over CA$1 billion could have been saved in just a two-year period [1].

Denosumab copy biological clinical trial application accepted in China

Biosimilars/News | Posted 27/03/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted a clinical trial application of denosumab copy biological HLX14.