Analysis of the potential cost savings from the use of three biosimilars (filgrastim, infliximab and insulin glargine) in Canada shows that over CA$1 billion could have been saved in just a two-year period [1].

The US Food and Drug Administration (FDA) is soon to transition many new drug applications (NDAs) to biologicals license applications (BLAs), with significant implications for biotechnology companies and drug compounders.

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of denosumab copy biological HLX14.

Patients with lower incomes are more likely to use generic drugs, finds a literature review from Auburn University, Alabama, USA [1].

Switzerland-based pharmaceutical giant Roche is continuing to pursue legal action in India over a trastuzumab similar biologic and has recently been fined in Romania for delaying the entry of biosimilars to the market.

Celltrion and Teva announced in March 2020 that they have launched their trastuzumab biosimilar Herzuma (trastuzumab-pkrb) in the US. Herzuma can be used to treat breast and gastric cancer and has recently been approved in Canada [1].

At the end of December 2019, Clover Biopharmaceuticals (Clover), a Chinese company focused on biological therapies, announced the start of a phase III trial of their etanercept copy biological (SCB-808), a proposed copy biological to originator biological Enbrel (etanercept).

Clinical oncologist, Dr Debra Patt, who serves on the US Oncology Research Breast Cancer Committee and chairs the breast cancer subsection of the pathways task force for The US Oncology Network, expresses her opinion on a new policy introduced by Medicare, which she believes is ‘having a negative impact on a patient’s outcome’.

The high cost of originator biologicals in Canada has created a demand for biosimilars as a way of reining in costs for Canadian public healthcare payers. However, although several biosimilars are now commercially available in the country for a variety of conditions [1]; it has been suggested that the uptake of biosimilars in Canada remains low [2].

Positive results were reported from a phase I trial of a bevacizumab copy biological, QL1101, which the authors say is ‘the first study to compare the pharmacokinetics of QL1101, a proposed bevacizumab [copy biological], with Avastin’ [1].