Biosimilars
EMA accepts first application for Chinese-made biosimilar HLX02
China-based Shanghai Henlius Biotech (Henlius) announced on 21 June 2019 that the regulatory submission for its proposed trastuzumab biosimilar (HLX02) had been accepted by the European Medicines Agency (EMA).
South Korea’s Celltrion to sell directly to Australia
In a successful month for Celltrion, the company announces plans to directly sell its anticancer biosimilars in Australia and begins a clinical trial for allergy treatment CT-P39.
Rituximab copy biological accepted for review in China
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for approval of rituximab copy biological IBI301.
Real-world data on switching of etanercept biosimilars
Real-world and clinical data from different studies involving switching to etanerept biosimilars were presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].
FDA approves rituximab biosimilar Ruxience
US-based pharma giant Pfizer announced on 23 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar (PF 05280586).
Long-term safety results for adalimumab biosimilar
ABP 501 is an adalimumab biosimilar which was compared to reference adalimumab in a 24-week phase lll study demonstrating equivalent efficacy and similar safety and immunogenicity [1]. The results of this clinical trial, along with the totality of evidence from analytical and biofunctional evaluation, lead to the approval of this adalimumab biosimilar for rheumatoid arthritis in the European Union and the US. ABP 501 is marketed as Amgevita in Europe and other markets. However, it will not be available in the US until 2023 due to an agreement between Amgen, the developer of the biosimilar, and AbbVie who manufactures the originator product, Humira (adalimumab) [2].
Positive phase III data for adalimumab copy biologicals
Positive phase III data for adalimumab copy biologicals has been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].
Lannett starts phase I trial for insulin glargine biosimilar in South Africa
US generics maker Lannett Company (Lannett) announced on 5 June 2019 that it had started a phase I clinical trial of its candidate insulin glargine biosimilar.
NHS England updates its ‘What is a Biosimilar Medicine?’
The National Health Service (NHS) England announced that it had updated its ‘What is a Biosimilar Medicine?’ document in June 2019.
EMA accepts application for bevacizumab biosimilar from Samsung Bioepis
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 19 July 2019 that the application for approval for its proposed bevacizumab biosimilar SB8 has been accepted for review by the European Medicines Agency (EMA).
