Biosimilars/General
WHO prequalifies Celltrion’s trastuzumab biosimilar Herzuma
The World Health Organization (WHO) has prequalified Celltrion Healthcare’s second biosimilar, a trastuzumab biosimilar sold as Herzuma.
Clinical trials for trastuzumab biosimilars
Roche’s originator trastuzumab biological (Herceptin) was approved by the US Food and Drug Administration (FDA) in September 1998 and by the European Medicines Agency (EMA) in August 2000 [1]. The patents on Herceptin expired in Europe in July 2014 and in the US in June 2019 [1]. This has led to biosimilars of trastuzumab being developed.
Biosimilar pipelines for Korean firms looking healthy
Korean companies are becoming more and important both in the country but also worldwide when it comes to developing biosimilars.
New Zealand IBD charity releases position statement on biosimilars
The charity Crohn’s and Colitis New Zealand has released a position statement on biosimilars, although there are not yet any biosimilars for inflammatory bowel disease (IBD) on the market in New Zealand.
Switching from biologicals to biosimilars in Australia
Switching* patients from originator biologicals to biosimilars has been a topic of keen interest in recent years across the globe, as more biosimilars have emerged onto the market. Authors from Shelston Intellectual Property discussed the unique approach that Australia has taken to switching.
Medscape hosts virtual symposium on biosimilars in IBD
Medscape held a virtual symposium on the use of biosimilars in inflammatory bowel disease (IBD) on 30 May 2020. The event covered issues including the regulatory approval process for biosimilars, research on biosimilars and switching.
ISOPP publishes a whole host of information on biosimilars
The International Society of Oncology Pharmacy Practitioners (ISOPP) has published a whole host of information on biosimilars in a supplementary issue of the Journal of Oncology Pharmacy Practice.
WHO prequalifies first rituximab biosimilar
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
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
US-based biotech giant Amgen explains on its websites the steps involved in manufacturing a biosimilar.
