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

To waive or not to waive: that is the question

By Naomi Pearce | May 12, 2021

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IP waivers alone are nowhere near enough to increase COVID-19 vaccine access for developing countries, but US support for such waivers will create enormous pressure on existing manu...
UK's MHRA finalises biosimilar guidance

By Bioblast Editor | May 12, 2021

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The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) finalised its ‘Guidance on the licensing of biosimilar products’, outlining the licensing requirements for biosimilars in the post-Brexit UK. The MHRA had previously foreshadowed in its dr...
Alvotech takes front foot approach and commences suit against AbbVie

By Bioblast Editor | May 11, 2021

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Alvotech filed a federal lawsuit against AbbVie in the US District Court of the Eastern District of Virginia, seeking to clear patent barriers relating to proposed biosimilar adalimumab, AVT02. Alvotech alleges that AbbVie has sought to protect its product monopoly by R...
Pearce IP BioBlast®: w/e 07 May 2021

By Naomi Pearce | May 10, 2021

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01 May 21 | Samsung Bioepis announced a new study demonstrating the structural, physicochemical and biological similarity between its SB11 (proposed ranibizumab biosimilar) and Lucentis...
Coherus reports Q1 2021 financial results

By Bioblast Editor | May 06, 2021

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Coherus BioSciences reported its Q1 2021 financial results. Coherus disclosed that it has commenced the rolling submission of the BLA for toripalimab and that it expects to file the BLA for CHS-201 (proposed ranibizumab biosimilar) mid-2021.
Alberta expands biosimilar switching program

By Bioblast Editor | May 06, 2021

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The Government of Alberta announced it has expanded its biosimilars switching program to include adalimumab for all originator indications except pediatric juvenial idiopathic arthritis. All adult patients on Humira® will be switched to Amgevita®, Hadlima®, Hulio®, Hyrimoz®...
Quaker out of grace in the Full Court as the reasonable trial grace period is limited

By Naomi Pearce | May 05, 2021

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Date: 5 May 2021Court: Full Court of the Federal Court of AustraliaJudges: Beach, Moshinsky and Thawley JJ
Background
Australian Patents AU2012304245 and AU2013100458 (P...
NSW & Victoria compete to establish AU's first mRNA manufacturing facility

By Naomi Pearce | May 05, 2021

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In light of the COVID-19 vaccine supply shortages in Australia, it was refreshing to hear NSW Premier Gladys Berejiklian announce yesterday that the NSW Government will establish go...
Hetero submits application for biosimilar tocilizumab

By Bioblast Editor | May 05, 2021

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ThePrint reported that Hetero Labs has submitted an application to start clinical trials and manufacture of biosimilar tocilizumab in India. Tocilizumab has been recommended for off-label use in the treatment of COVID-19 by the Indian Government, but has been subject to ext...
Amgen launches Amgevita® (biosimilar adalimumab) in Canada

By Bioblast Editor | May 04, 2021

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Amgen launched Amgevita® (biosimilar adalimumab) in Canada. Amgevita® is available in 50mg/mL PFS and pen presentations and is citrate-free. Amgevita® will be reimbursed on the public drug plans in BC, Alberta, Ontario, Quebec, New Brunswick and Newfoundland.