Biosimilars/General

WHO prequalifies first rituximab biosimilar

Biosimilars/General | Posted 05/06/2020

The World Health Organization (WHO) has prequalified its first rituximab biosimilar as part of its efforts to make life-saving treatments more affordable and available to patients globally.

Biosimilar Awareness Week in Australia

Biosimilars/General | Posted 05/06/2020

The second Biosimilar Awareness Week took place on 25–29 May 2020 in Australia. It involved discussion on social media and aimed to increase awareness and confidence in biosimilars among consumers and healthcare professionals.

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.

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.

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.

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.