Biosimilars

ISOPP publishes a whole host of information on biosimilars

Biosimilars/General | Posted 12/06/2020

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.

First subjects dosed in Australian phase I study of denosumab biosimilar

Biosimilars/Research | Posted 12/06/2020

Taiwan-based JHL Biotech announced on 18 May 2020 that the first group of subjects has been randomized and dosed in the week of 11 May 2020 in the company’s Australian phase I clinical trial of its candidate denosumab biosimilar (JHL1266) in healthy subjects.

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.

EMA recommends approval of trastuzumab biosimilar Zercepac

Biosimilars/News | Posted 05/06/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 29 May 2020 that it had recommended granting of marketing authorization for a biosimilar trastuzumab product.

Teva launches rituximab biosimilar Truxima in US

Biosimilars/News | Posted 05/06/2020

Israeli generics giant Teva Pharmaceutical Industries (Teva) and partner, South Korean biotechnology company Celltrion, announced on 4 May 2020 that they had launched their rituximab biosimilar Truxima (TL011) in the US.

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.

Samsung Bioepis releases data on trastuzumab and ranibizumab biosimilars

Biosimilars/Research | Posted 05/06/2020

Samsung Bioepis has released follow-up data for its approved trastuzumab biosimilar Ontruzant, as well as interim results for its proposed Lucentis (ranibizumab) biosimilar.

Patients’ perceptions of switching to biosimilars

Biosimilars/Research | Posted 05/06/2020

A patient’s characteristics make them more likely to have negative perceptions about switching to biosimilars, according to a study by researchers from New Zealand [1].

Safety of switching between reference products and biosimilars

Biosimilars/Research | Posted 29/05/2020

The safety of switching a patient under chronic treatment with a reference biological to a biosimilar has been a topic of ongoing debate since the first biosimilar approval in Europe in 2006. The topic sparked further discussion with the arrival of the more complex monoclonal antibody biosimilars. Concerns have been raised that switching between highly similar but non-identical versions of a biological medicine might lead to increased immunogenicity and as such, impact treatment outcomes. The existing stakeholder uncertainty regarding the safety of switching may have been curbing the use of biosimilars in clinical practice and guidance to support healthcare professionals with clinical decision-making is needed.

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.