Date: 19 November 2021Court: Full Court of the Federal Court of AustraliaJudges: Middleton, Perram and Nicholas JJ
Background
In 2018 the Australian Patent Office refuse...
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By Naomi Pearce | Nov 19, 2021
Date: 19 November 2021Court: Full Court of the Federal Court of AustraliaJudges: Middleton, Perram and Nicholas JJ
Background
In 2018 the Australian Patent Office refuse...
By Naomi Pearce | Nov 18, 2021
Date: 18 November 2021Court: Federal Court of AustraliaJudge: Burley J
Background
In December 2016 Pfizer Ireland Pharmaceuticals (Pfizer) filed a preliminary discovery...
By Bioblast Editor | Nov 17, 2021
Samsung Bioepis launched a new white paper entitled ‘Improving the Understanding and Acceptance of Biosimilars in the United States’. In particular, the paper discusses the need to reduce information gaps, incentivise different stakeholders and practical considerations for ...
By Bioblast Editor | Nov 17, 2021
Pharmac announced that it will transfer Principal Supply status from Humira® (adalimumab) to Amgevita® (biosimilar adalimumab) from 01 March 2022.
By Naomi Pearce | Nov 16, 2021
The speed of getting a case to trial is a key metric of any litigation system. Pharmaceutical patent litigation often plays out on the cusp of patent expiry when a new market entrant s...
By Bioblast Editor | Nov 16, 2021
Viatris and Biocon Biologics announced the US launch of Semglee® (interchangeable biosimilar insulin glargine) and Insulin Glargine.
By Naomi Pearce | Nov 16, 2021
09 Nov 21 | Coherus BioSciences reported its Q3 2021 financial results. Coherus announced that FDA review of CHS-201 (proposed adalimumab biosimilar) is advancing towards the target...
By Bioblast Editor | Nov 15, 2021
Celltrion announced that the EC has approved Regkirona® (regdanvimab, CT-P59) for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
By Bioblast Editor | Nov 12, 2021
AU’s PBAC published the outcomes from its July 2021 meeting. PBAC recommended listing:
Pfizer’s Abrilada® (50mg/mL adalimumab biosimilar) in 20mg/0.4mL syringe, 40mg/0.8mL syringe and 40mg/0.8mL pen for all indications as Humira®.
Janssen’s Darzalex SC® (da...
By Bioblast Editor | Nov 12, 2021
RegenXBio announced additional interim data from its Ph II trials of RGX-314 (proposed one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases). RGX-314 is a recombinant adeno-associated virus ...
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