Biosimilars/News
EMA recommends approval of eculizumab biosimilar Bekemv
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 February 2023 that it had recommended granting of marketing authorization for the eculizumab biosimilar Bekemv.
China approves tocilizumab copy biological BAT1806
In January 2023, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) approved BAT1806, a biosimilar of Actemra (tocilizumab), in China. This is the world’s first tocilizumab copy biological/biosimilar to be approved.
FDA accepts application for denosumab biosimilar GP2411
Sandoz, the generics division of Novartis, announced on 6 February 2023 that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for a proposed denosumab biosimilar (GP2411).
EMA accepts application for ustekinumab biosimilar AVT04
Alvotech announced on 9 February 2023 that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, their proposed biosimilar to Stelara (ustekinumab).
Ranibizumab biosimilar Ximluci and Amelivu to launch in the UK and South Korea
STADA and Xbrane Biopharma have announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Ximluci, a biosimilar referencing ophthalmology drug, Lucentis (ranibizumab). In addition, Samsung Bioepis and Samil Pharmaceuticals will launch their biosimilar of Lucentis, Amelivu, in South Korea.
New indication for Cosentyx (secukinumab) biological: hidradenitis suppurativa
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use adopted a positive opinion on 26 April 2023 recommending Novartis' Cosentyx (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults.
Advances for Henlius’ trastuzumab and bevacizumab biosimilars in the US
The US Food and Drug Administration (FDA) accepted Henlius' application for HLX02 (biosimilar trastuzumab for injection). Meanwhile, Henlius' multicentre phase III clinical trial (NCT04740671) of HLX04-O (biosimilar bevacizumab) for wet age-related macular degeneration (wAMD) commenced in the US with the first patient dosed.
First African developed biosimilar adalimumab starts phase I trial in Germany
A phase I clinical trial of Minapharm Pharmaceuticals’ first African developed adalimumab biosimilar, Adessia, was initiated on 24 February 2023 in Germany with results to be expected at the end of 2023.
Bevacizumab biosimilar Vegzelma approved and Aybintio launched in Canada
The bevacizumab biosimilar Vegzelma produced by Celltrion received full label approval from Canada’s drug regulator, Health Canada (HC), on 3 January 2023. Back in November 2022, bevacizumab biosimilar Aybintio by Samsung Bioepis had been launched in Canada by Organon, offering a more affordable treatment for Canadian patients suffering from certain types of aggressive cancer.
Advances for Alvotech’s partnerships in Japan, Canada and Switzerland
In October 2022, Alvotech announced new advances with partners Fuji Pharma in Japan and JAMP in Canada. In addition, in September 2022, with its partner STADA, Alvotech announced the launch of Hukyndra, its high-concentration, low-volume, citrate-free formulation, biosimilar to Humira (adalimumab), in Switzerland.
