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EU approves Henlius copy biologicals facility in China

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.

Amgen explains the steps of manufacturing a biosimilar

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

Reimbursement of biosimilars in the US

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

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

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.

Online education for diabetes specialists on biosimilar insulins

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

New information on biosimilars from Australia and the US

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

FDA releases new information on interchangeable biologicals

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.

Biosimilars highlights: 2019

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.

British Columbia releases latest data on biosimilar switches

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.