PearceIP Blog

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Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.

When exclusive licensees have no rights to sue or recover damages during patent term extensions

By Naomi Pearce | Mar 26, 2021

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In February 2021, H. Lundbeck A/S (Lundbeck) was granted special leave by the High Court to appeal the 2020 Full Court decision[1] involving the long running litigation in relation ...
AU's PBAC makes changes to adalimumab listings

By Bioblast Editor | Mar 26, 2021

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A number of changes have been made to the PBS listings of adalimumab. From 1 April:

The Amgen, Merck/Samsung, Sandoz and Fresenius 50mg/ml products will be PBS listed and A flagged against the 50mg/ml Humira formulations for all approved indications; and
Hu...
The COVID-19 pandemic prioritises an Australian medical products’ manufacturing road map

By Kate Legge | Mar 25, 2021

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Background
In October 2020, the Australian Government announced a $1.5 billion investment in a Modern Manufacturing Strategy (MMS) to help Australian manufacturers become more...
LG Chem receives approval for its biosimilar adalimumab in Japan

By Bioblast Editor | Mar 25, 2021

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Korea Biomedical Review reported that LG Chem has received approval from Japan’s Health Ministry for its biosimilar adalimumab. The product will be commercialised by Mochida Pharmaceuticals.
mAbxience announces new 4,000L CSR bioreactor

By Bioblast Editor | Mar 25, 2021

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mAbxience announced it will install an ABEC 4,000L CSR bioreactor at its site in Leon, Spain. The system is expected to be installed within months, and will boost mAbxience’s biosimilar and CDMO manufacturing capacity.
EirGenix announced positive Ph III results for trastuzumab biosimilar

By Bioblast Editor | Mar 24, 2021

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EirGenix announced that its Ph III clinical trial of EG12014 (proposed trastuzumab biosimilar) has met its primary endpoint. EirGenix announced that EG12014 has shown equivalent efficacy to Herceptin®, and demonstrated a comparable safety profile.
Pearce IP BioBlast®: w/e 19 March 2021

By Naomi Pearce | Mar 22, 2021

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15 March 2021 | Alvotech announced it has completed a second round of its US$100 million private placement. In the first round, Alvotech raised US$65 million, including investments fro...
Federal Court expedites another pharma patent trial

By Naomi Pearce | Mar 19, 2021

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Date: 19 March 2021
Court: Federal Court of Australia
Judge: Beach J
Background
Celgene Corporation (Celgene) markets lenalidomide for a number of blood can...
Herzuma® gains 44% market share in Japan

By Bioblast Editor | Mar 17, 2021

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The Korea Herald reported that Celltrion’s Herzuma® (biosimilar trastuzumab) reached a 44% market share in Japan last year.
Pfizer to sell Chinese manufacturing site

By Bioblast Editor | Mar 17, 2021

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Reuters reported that Pfizer will stop producing biosimilar products in China and will sell an intended manufacturing site in Hangzhou to WuXi Biologics.