Home / Biosimilars / News

News

Mylan launches first trastuzumab biosimilar in Australia

Global generics firm Mylan NV (Mylan) and collaborating Indian pharmaceuticals giant Biocon Ltd (Biocon) have announced the launch of the first trastuzumab biosimilar in Australia. The drug can be used to treat breast and stomach cancers and will be marketed as Ogivri.

Samsung Bioepis starts phase III trial for eculizumab copy biological

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is carrying out a phase III clinical trial for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).

Korean firms to launch biosimilars in Japan despite trade tensions

Despite increasing trade tensions between Japan and Korea, two Korean firms have confirmed that they intend to move ahead with the launch of their darbepoetin alfa biosimilars in Japan in the second half of 2019.

FDA approves adalimumab biosimilar Hadlima

Korea-based biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 24 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (SB5).

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).

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.

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).

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.

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).

Sandoz to start phase III trial for denosumab biosimilar

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.

Generics News Research General

more

Biosimilars News Research General

more