Biosimilars
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.
Samsung Bioepis releases data on trastuzumab and ranibizumab biosimilars
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
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
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
US-based biotech giant Amgen explains on its websites the steps involved in manufacturing a biosimilar.
Hepatobiliary events similar for SB4 and Enbrel in IJD
According to a study carried out by researchers from Denmark, hepatobiliary adverse events occur at a similar frequency in patients treated with the etanercept biosimilar Benepali (SB4) compared to the originator product, Enbrel, in inflammatory joint disease (IJD) [1].
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.
Trials of ustekinumab biosimilars advance
Japan-based Meiji Seika Pharma, together with the South Korean company Dong-A, have begun a phase I trial for their ustekinumab biosimilar. Meanwhile, the Australian firm NeuClone has reported results from the phase I trial of its ustekinumab biosimilar, NeuLara.
Do patent strategies delay market entry of biosimilar monoclonal antibodies in Europe?
Patents have been shown to be the main determinant to guarantee market exclusivity of originator biologicals [1], with patent disputes causing uncertainty on a patent’s validity and subsequently potentially influencing launch dates of competitor products, such as biosimilars [2]. In addition, the launch date of a biosimilar might be affected by strategies for prolongation of exclusivity rights on the originator product, such as filing additional patents for a new formulation, new indication or new dosage regime [3].
Canada approves rituximab biosimilars Riximyo and Ruxience
Canada’s drug regulator, Health Canada, has approved the rituximab biosimilars Riximyo (GP2013) and Ruxience (PF-05280586) for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.
