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Celltrion Healthcare presented its positive phase III results for its infliximab biobetter Remsima SC® as a sub-cutaneous maintenance therapy for patients with IBD.  Remsima SC® (CT-P13 SC) is Celltrion’s subcutaneous re-formulation of Johnson & Johnson’s infliximab (Re...

The ‘Increasing Access to Biosimilar Act of 2023’ (HR 1352) was introduced into the US House of Representatives.  The bill, if passed by Congress, would ‘require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar...

Biogen Canada Inc. announced that its Lucentis® (ranibizumab) biosimilar Byooviz™ is available in Canada following approval by Health Canada for treatment of serious eye disorders including neovascular (wet) age-related macular degeneration. On 2 June 2022, Byooviz™ was lau...

On Thursday, US District Court Judge Noreika denied a motion filed by Janssen Biotech, Inc (a Johnson & Johnson subsdiary) for a preliminary injunction regarding Amgen’s ustekinemab biosimilar, because the motion did not comply with the court’s page limit requirements. ...

Samsung revealed in a South Korean regulatory filing that it has entered into a KRW$241 billion (~USD$183M) contract with Pfizer. The ‘Biologics CMO Contract’ is effective between 28 February 2023 and 31 December 2029 and relates to the manufacture of unnamed biologics by S...

The FDA provided an update on its collaboration with the Federal Trade Commission (FTC) which it announced in February 2020.  The FDA and FTC have been working together on issues including exchanging information about how to combat anti-competitive activities and those that...

A Turgut İlaçları study published in the Turkish Journal of Pharmaceutical Sciences indicated that Turgut’s TUR01, biosimilar to Amgen’s Humira® (adalimumab), was stable when stored under long-term storage conditions at for at least 18 months and for 24 months.  In 2020, Tu...

The November 2022 PBAC meeting has recommended the following biologics for PBS listing:

Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms for the same indications as the currently listed pre-filled syringe, to treat chronic severe atopic dermatit...

Alvotech announced its full financial results for 2022, highlighting its annual revenue increased by 114% to USD$85M, primarily driven by the commercialisation of AVT02 (adalimumab), biosimilar to AbbVie’s Humira® in 17 countries.  As of December 31, 2022, the company had c...