Biosimilars

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.