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Smart & Biggar | Canada | 18 Jan 2023

2022 highlights in Canadian life sciences IP and regulatory law

đź•‘ 14 minutes This article highlights the main developments that took place in the Canadian life sciences industry in 2022. It covers patent decisions on the merits from the Federal Court and the Federal Court of Appeal, along with updates relating to the Patented Medicines (Notice of Compliance) Regulations, the Patented Medicine Prices Review Board, biosimilars and the Competition Bureau,......
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Eversheds Sutherland (International) LLP | European Union | 14 Dec 2022

European Medicines Agency and Heads of Medicines Agencies issue statement on interchangeability of EU-approved biosimilars

đź•‘ 1 minute The European Medicines Agency and the Heads of Medicines Agencies recently issued a statement to clarify that an EU-authorised biosimilar medicine should be regarded as interchangeable with its reference product or with a biosimilar of that same reference product. The press release explains that the intention is to clarify an EU-wide position on interchangeability of biosimilars......
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Pearce IP | Australia, European Union, USA | 12 Dec 2022

BioBlast w/e 09 Dec 22: Roche’s glofitamab, Paras Biopharma’s new biosimilars division, Biogen’s biosimilar tocilizumab, Alvotech/Stada’s EU Hukyndra® roll out, Biocon closes Viatris biosimilar business

A new Roche study published in the New England Journal of Medicine reported that first in class bispecific (anti-CD20/anti-CD3) antibody glofitamab…
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Pearce IP | Australia, United Kingdom, USA | 5 Dec 2022

BioBlast w/e 02 Dec 22: Janssen sues Amgen over ustekinumab, Capstone’s insulin, Erasca trials, Alvotech leadership changes, MHRA Dupixent® guidance, Merck sues JHU on Keytruda patents, Hikma and Celltrion ustekinumab deal

Alvotech announced that Nasdaq Iceland has approved its request for the admission of its shares on the Nasdaq Iceland Main Market under the ticket…
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Smart & Biggar | Canada | 23 Nov 2022

Saskatchewan launches biosimilars initiative

đź•‘ 1 minute Saskatchewan recently announced it is introducing a biosimilars initiative. For any new patients starting a biologic drug, the Saskatchewan Drug Plan will only offer coverage for the listed biosimilar version. Patients already receiving an original biologic drug are expected to transition to a biosimilar version by 30 April 2023. Saskatchewan joins five other provinces and the......
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Pearce IP | Australia | 21 Nov 2022

BioBlast w/e 18 Nov 22: Eli Lilly’s interchangeable insulin glargine, Organon trastuzumab and bevacizumab launches, Biocon Viatris’ biosimilar asset acquisition, Janssen guselkumab study, NICE Keytruda® recommendation, Stelis’ teriparatide

The FDA approved Eli Lilly’s Rezvoglar® (biosimilar insulin glargine) as an interchangeable biosimilar to Lantus®. Rezvoglar was approved as a…
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Pearce IP | Australia, USA | 17 Oct 2022

BioBlast® w/e 14 Oct 22: BioFactura’s ustekinumab, Prestige’s trastuzumab, Merck/Moderna personalised cancer vaccine combo, Regeneron’s aflibercept, Jacobio Pharma/Merck’s cetuximab, Janssen’s guselkumab/golimumab, Alvotech’s aflibercept

BioFactura has announced successful completion of its Ph I trials relating to biosimilar ustekinumab candidate BFI-751. The trial in Australia and…
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