Biosimilars/News
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.
Progress for Lucentis (ranibizumab) biosimilars in Europe and the US
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.
Advances for adalimumab biosimilars in Saudi Arabia, Europe and Canada
In January 2023, Alvotech-Bioventure, Sandoz and Samsung Bioepis announced advances for their adalimumab biosimilars in Saudi Arabia, Europe and Canada, respectively.
New insulin glargine and potential adalimumab interchangeable biosimilars
The US Food and Drug Administration (FDA) awarded Eli Lilly’s Rezvoglar, an insulin glargine biosimilar, the interchangeable designation in late 2022. This means that in the US, Rezvoglar can now be substituted at the pharmacy level for the originator, Sanofi’s Lantus, without a doctor’s prescription, provided state pharmacy law permits the switch. In addition, a study revealed that Pfizer’s adalimumab biosimilar may also soon achieve this status.
Biosimilar advances for Alvotech-Teva and setback for Biocon Biologics
Alvotech and Teva Pharmaceuticals announced in January 2023, that the US Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). Meanwhile, Biocon Biologics received a complete response letter (CRL) from FDAregarding its application for an insulin aspart biosimilar (filed by its partner Viatris).
Advances for Bio-Thera’s secukinumab and mepolizumab copy biologicals
China’s Bio-Thera Solutions announced in November 2022 that dosing has begun in a phase III clinical study for BAT2306, a proposed copy biological of arthritis anti-inflammatory treatment, Cosentyx (secukinumab). In addition, the company also recently announced a phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed copy biological of asthma treatment, Nucala (mepolizumab), to US-sourced and EU-sourced reference product in normal healthy volunteers.
FDA and EMA file acceptance of Biogen’s tocilizumab biosimilar
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
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
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.
Bevacizumab biosimilar approvals and launch in Japan and USA
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.
