Biosimilars
Cost savings from the use of biosimilars in Canada
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].
Denosumab copy biological clinical trial application accepted in China
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted a clinical trial application of denosumab copy biological HLX14.
Celltrion/Teva launch trastuzumab biosimilar Herzuma in US
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].
Clover starts phase III trial for etanercept copy biological in China
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).
US oncologist says Medicare should not practice medicine
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’.
Positive phase I results for Qilu’s bevacizumab copy biological
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].
Celltrion launches infliximab biosimilar Remsima SC in Europe
In a successful time for Celltrion Healthcare (Celltrion), the company has launched their infliximab biosimilar Remsima in Germany and the UK.
PK and PD similarity between pegfilgrastim biosimilar and Neulasta
Hexal AG has published phase I results for its approved pegfilgrastim biosimilar [1-3].
FDA and FTC collaborate to deter anti-competitive behaviour for biologicals
The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced on 3 February 2020 that they would enhance their collaboration when it comes to anti-competitive behaviour in the biologicals’ marketplace.
Arguments against Alberta’s plans to switch patients to biosimilars
In May 2019, the Canadian province of British Columbia introduced a policy of switching rheumatology patients to biosimilars [1]. Now, the province of Alberta is also considering plans to stop coverage of originator biologicals and switch patients to biosimilars for certain indications. The new policy, if introduced, will apply to the approximately 30,000 patients in Alberta living with inflammatory bowel disease (IBD) [2].
