FDA and EMA file acceptance of Biogen’s tocilizumab biosimilar

Biosimilars/News | Posted 12/12/2022

Biogen announced on 9 December 2022 that the US Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (BLA) for BIIB800, a biosimilar candidate referencing Roche’s Actemra/RoActemra (tocilizumab); and on 30 September 2022 that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for BIIB800.

Canada approves etanercept biosimilar Rymti

Biosimilars/News | Posted 01/12/2022

The etanercept biosimilar Rymti, produced by Lupin, received approval from Canada’s drug regulator, Health Canada (HC), on 13 September 2022, for all indications of the reference product Enbrel. This is the third etanercept biosimilar to receive approval in Canada [1].

Australia and EU: Alvotech Humira and Stada Lucentis biosimilars approved

Biosimilars/News | Posted 25/11/2022

In November 2022, Alvotech announced that the Therapeutic Goods Administration (TGA) of Australia has granted marketing authorization for its a high-concentration low-volume adalimumab, AVT02, a biosimilar referencing Humira and marketed by their partner, Cipla Australia. In addition, Stada Arzneimittel and Xbrane Biopharma announced that the European Commission granted marketing authorization for their Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis. 

Advances for Alvotech’s partnerships in Japan, Canada and Switzerland

Biosimilars/News | Posted 18/11/2022

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.

Progress for Lucentis (ranibizumab) biosimilars in Europe and the US

Biosimilars/News | Posted 28/10/2022

On 16 September 2022, Partners Stada Arzneimittel and Xbrane Biopharma announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Ximluci, a biosimilar candidate referencing Lucentis (ranibizumab). In addition, on 19 September 2022 in the US, Coherus BioSciences announced that from 3 October 2022, another ranibizumab biosimilar, Cimerli (ranibizumab-eqrn) will be commercially available. 

Bevacizumab biosimilar approvals and launch in Japan and USA

Biosimilars/News | Posted 21/10/2022

On 27 and 28 September 2022, Celltrion announced that its oncology biosimilar bevacizumab, Vegzelma, has been approved in Japan and the US. In October 2022, Amneal Pharmaceuticals, also announced the launch of Alymsys (bevacizumab-maly) in the US.

Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin

Biosimilars/News | Posted 14/10/2022

On 19 September 2022, Formycon announced details of a project to produce a biosimilar of Keytruda (pembrolizumab). This followed news that, on 16 September 2022, Prestige Biopharma withdrew the Marketing Authorization Application (MAA) for their Herceptin Biosimilar, Tuznue, submitted to the European Medicines Agency (EMA).

FDA approves biosimilar pegfilgrastim Stimufend

Biosimilars/News | Posted 07/10/2022

On 6 September 2022, Fresenius Kabi announced that they had received approval from the US Food and Drug Administration (FDA) for their pegfilgrastim biosimilar, Stimufend (pegfilgrastim-fpgk).

EC approves bevacizumab biosimilar Vegzelma

Biosimilars/News | Posted 23/09/2022

On 18 August 2022, South Korea-based biologicals specialist Celltrion announced that its bevacizumab biosimilar, Vegzelma (CT-P16), had received European Commission (EC) approval.

FDA accepts application for high concentration adalimumab biosimilar

Biosimilars/News | Posted 16/09/2022

Sandoz, the generics division of Novartis, announced on 21 July 2022 that the US Food and Drug Administration (FDA) had accepted the supplemental biologics license application for the high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017) (adalimumab-adaz).