Biosimilars

Lannett starts phase I trial for insulin glargine biosimilar in South Africa

Biosimilars/News | Posted 02/08/2019

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?’

Biosimilars/General | Posted 02/08/2019

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

Biosimilars/News | Posted 26/07/2019

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).

Positive results for rituximab non-originator and copy biologicals

Biosimilars/Research | Posted 26/07/2019

Positive results for the rituximab non-originator biological BCD-020 (AcellBia) and for the rituximab copy biological HLX01 (Hanlikon) have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1, 2].

Positive phase III results for trastuzumab biosimilar HD201

Biosimilars/Research | Posted 26/07/2019

Singapore-based Prestige BioPharma (Prestige) announced on 24 June 2019 positive phase III data for its trastuzumab biosimilar, HD201. The results, according to Prestige, ‘confirm the similarities between HD201 and trastuzumab’.

South Korea increases investment in biologicals

Biosimilars/General | Posted 26/07/2019

Investment in the biotech sector is ramping up in South Korea, with increased state-led support and private sector pledges.

Sandoz to start phase III trial for denosumab biosimilar

Biosimilars/News | Posted 26/07/2019

Sandoz, the generics division of Novartis, is planning to start a phase III trial for its candidate denosumab biosimilar GP2411 in patients with post-menopausal osteoporosis in collaboration with Germany-based biosimilars maker Hexal.

FDA approves bevacizumab biosimilar Zirabev

Biosimilars/News | Posted 19/07/2019

US-based pharma giant Pfizer announced on 28 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its bevacizumab biosimilar Zirabev (PF-06439535).

Real-world data confirms safety of infliximab biosimilar CT-P13

Biosimilars/Research | Posted 19/07/2019

Positive real-world data has been presented for Celltrion’s infliximab biosimilar CT P13 at the European Congress of Rheumatology 2019 (EULAR 2019).

Clinical and real-world data for switching to biosimilars

Asian specialists' recommendations for off-patent biologicals in IBD

Biosimilars/Research | Posted 19/07/2019

Gastroenterologists from across Asia have published a list of recommendations for the use of biologicals and off-patent biologicals in inflammatory bowel disease (IBD) in Asia [1].