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Business Korea reported that Celltrion filed an application with Australia’s Therapeutic Goods Administration (TGA) for approval of CT-P43, its biosimilar to Janssen’s Stelara® (ustekinumab).   Celltrion applied for approval of all Stelara® indications, including plaque pso...

Novartis has commenced proceedings in the Federal Court of New Jersey against the US Government two days after the Centers for Medicare and Medicaid Services (CMS) unveiled the first 10 drugs that will undergo new pricing negotiations with the US Government.  These pricing ...

Alvotech announced in its 2023 Q2 Earnings Presentation that it has resubmitted its interchangeable BLA for AVT02, biosimilar to AbbVie’s high concentration Humira® (adalimumab). The company did not disclose the BsUFA date but anticipated launch in 2024.

The FDA issu...

Outlook Therapeutics announced the FDA issued it with a Complete Response Letter (CRL) for its BLA for ONS-5010, biosimilar to Genentech’s Avastin® (bevacizumab). The FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, but could not approve t...

Celltrion Healthcare Canada announced that Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), is now available in an 80 mg auto-injector and pre-filled syringe. It is the only adalimumab biosimilar available at an 80 mg dose in an auto-injector.

On 1 July 2023, Y...

Alvotech published its first half 2023 financial results, reporting a revenue growth to $22.7M for the six months ending 30 June 2023, compared to $3.9M for the same six months of 2022.  Revenue for that period consisted of product revenue from sales of AVT02 (Alvotech’s ad...

The Patent Trial and Appeal Board (PTAB) issued decisions in Celltrion’s two inter partes reviews (IPRs) (IPR2022-00578 and IPR2022-00579), finding Chugai and Roche’s tocilizumab patents (US patent nos. 8,580,264 and 10,874,677) were invalid.  The PTAB found that claims 1-1...

The Korea Herald reported that Dong-A ST submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for its Stelara® biosimilar DMB-3115.  DMB-3115 was jointly developed by Dong-A and Meiji Seika Pharma, and will be commercialised in Europe by th...