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Home / News / Pearce IP Blog

PEARCE IP BLOG

Read our latest updates & insights

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

BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

by | Feb 20, 2023

Significant biosimilar activities this week include: 18 Feb 23 | Takeda publishes results of Ph III trials of vedolizumab in preventing intestinal acute graft-versus-host disease...

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BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

BioBlast f/e 10 Feb 2023: Alvotech’s ustekinumab & omalizumab, new US indication for Eylea®, Sandoz’s US denosumab biosimilar, Amgen US Amjevita® (adalimumab) launch, Sandoz’s citrate-free adalimumab, Celltrion’s Vegzelma™ (bevacizumab), MSD Keytruda® trial, Celltrion aflibercept IPR, Sanofi’s Dupixent® (dupilumab) approval

by | Feb 13, 2023

Significant biosimilar activities this week include: 09 Feb 23 | EU | EMA accepts MAA for Alvotech’s AVT04 (ustekinumab biosimilar) Alvotech and STADA announced that EMA has...

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BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

BioBlast® w/e 27 Jan 23: Alvotech Simlandi® (biosimilar adalimumab) approval, Alvotech completes private placement round, PTAB institutes Mylan aflibercept challenges, Dr Reddy’s rituximab, BeiGene’s denosumab, MHRA grants Ximluci® (biosimilar ranibizumab) marketing authorisation, NMPA approves BAT1806 (biosimilar tocilizumab), Genentech and Tanvex settlement, Luye Pharma denosumab

by | Jan 30, 2023

Significant biosimilar activities this week include: 24 Jan 23 | Saudi Food & Drug Authority approves Alvotech’s Simlandi® (biosimilar adalimumab) Alvotech and Bioventure...

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BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

BioBlast® w/e 06 January 2023: Biocon insulin, Alvotech ustekinumab, Celltrion Vegzelma™ (bevacizumab), Lannett’s biosimilar insulin products, Alteogen and Celltrion agreement, Samsung Bioepis adalimumab interchangeability, Amgen’s adalimumab, Ontario biosimilar switching program, Hikma and Celltrion bevacizumab agreement, Samsung Bioepis Hadlima® approval, Keytruda® trials, Celltrion’s subcutaneous infliximab, Alvotech adalimumab, Dr Reddy’s tocilizumab, ustekinumab biosimilar

by | Jan 9, 2023

Significant biosimilar activities this week include: 07 Jan 23 | Biocon receives complete response letter over insulin-r product. Biocon announced that it has received a complete...

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BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

BioBlast w/e 16 Dec 22: Doer Biologics and Merck collaboration, expanded Dupixent® indications, Fresenius US citrate-free Idacio® (adalimumab) approval, Merck and Moderna cancer vaccine trial results, Amgen acquires Horizon, Alvotech lists on Nasdaq Iceland Main Market, Regeneron seeks expedited motion in aflibercept dispute

by | Dec 19, 2022

Significant biosimilar activities this week include: 15 Dec 22 | Zhejiang Doer Biologics and Merck clinical trials Zhejiang Doer Biologics announced a clinical trial...

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BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

BioBlast w/e 11 Nov 22: Dupixent® recommended by CHMP, TME Pharma’s NOX-A12, World first denosumab biosimilar approved, Alvotech’s adalimumab IC data, Mylan’s IPR win against Regeneron aflibercept patents, MHRA biosimilars guidance, Amgen biosimilars data, Coherus’ ranibizumab

by | Nov 14, 2022

Significant biosimilar activities this week include: 11 Nov 22 | EU | CHMP recommends Dupixent® (dupilimab) for prurigo nodularis The CHMP recommended the approval of Dupixent®...

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BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

BioBlast w/e 04 Nov 22: dupilumab study, Accord cleans up at Global Generics and Biosimilars Awards, Amgen’s Supreme Court petition for certioriari regarding enablement granted, AU tocilizumab COVID shortage measures lifted, Bio-Thera’s secukinumab, Outlook’s ophthalmic bevacizumab, Rani Therapeutics’ oral ustekinumab

by | Nov 7, 2022

Significant biosimilar activities this week include: 04 Nov 22 | New dupilumab study suggests serum dupilumab levels are not associated with treatment response or adverse effects...

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BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

BioBlast® w/e 28 Oct 22: Expanded indications in CA for Roche’s tocilizumab, AU PBAC outcomes, Alvotech financial results, Biogen seeks PI against Sandoz in natalizumab dispute, JSR/Similis Bio agreement, Regeneron/Mylan expedited aflibercept hearing, Genentech trade secrets sentencing

by | Oct 31, 2022

Significant biosimilar activities this week include: 28 Oct 22 | Health Canada approves additional COVID-19 indication for Actemra® IV (tocilizumab) Roche Canada announced that...

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BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter

BioBlast® w/e 21 Oct 22: Spectrum’s eflapegrastim, Eylea® paediatric exclusivity, Saskatchewan biosimilars switching program, AbbVie acquires DJS Antibodies, Lupin FDA observations, Alvotech and JAMP expand partnership, Alvotech/Fuji Pharma, Biocon’s ustekinumab, denosumab

by | Oct 24, 2022

Significant biosimilar activities this week include: 21 Oct 22 | US | Spectrum Pharmaceuticals launched Rolvedon™ Spectrum Pharmaceuticals announced the US launch of Rolvedon™...

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Recent BioBlast® Updates

Teva/Samsung Bioepis Launch Epysqli® (Eculizumab-aagh) in US

Apr 7, 2025

On 7 April 2025, Teva and Samsung Bioepis announced the US launch of Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®. According to the joint announcement, Epysqli® will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of Soliris®…

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