Green light for patent reform in Australia

by Naomi Pearce | Aug 25, 2017

This afternoon, the Australian Government released its response to the report of the Productivity Commission Inquiry into IP released 20 December 2016. In its 25 page response to...

Amgen v Hospira: BPCIA dance lessons in the Federal Circuit

by Naomi Pearce | Aug 22, 2017

Just over a week ago, the US Federal Circuit provided BPCIA “dance lessons” for reference product sponsors and biosimilar applicants, as it handed down its decision in Amgen v...

TGA seeks input on biosimilar naming in Australia

by Naomi Pearce | Aug 1, 2017

The TGA consultation paper can be found here. The TGA paper outlines the biosimilar naming conventions implemented in EU (INN), Japan (BSn), and the planned US 4 letter biologics...

Recent BioBlast® Updates

Alvotech commences Ph I trials of AVT03 (denosumab) in male subjects

Jul 20, 2022

Alvotech announced that it has initiated a pharmacokinetic study for AVT03 (denosumab, biosimilar to Prolia®/Xgeva®). The study will assess the pharmacokinetics, safety and tolerability of AVT03 compared to Prolia® in healthy adult male subjects. Alvotech’s portfolio...

Novartis provides update on Sandoz and earnings data

Jul 19, 2022

Novartis published its financial results, reporting a 1% decrease USD (5% increase cc) in Q2 2022 sales over Q2 2021, and 3% decrease USD (5% increase cc) for Sandoz sales. Novartis confirmed that its strategic review of Sandoz is on track, and that it would provide...

Poland’s URPL approves IND for Celltrion’s CT-P47 (biosimilar tocilizumab)

Jul 19, 2022

Korea Biomedical Review reported that Celltrion has received approval from Poland’s Pharmaceutical and Medical Equipment Registration Office (URPL) for its IND for Ph III trials of CT-P47 (biosimilar to Actemra®, tocilizumab).

J&J report a 53% decrease in Remicade® exports

Jul 19, 2022

Johnson & Johnson reported a 53% YoY decrease in exports of Remicade® (infliximab) from the US suggesting a very significant decline in global Remicade sales since the first approved biosimilar in 2013.

Erasca and Eli Lilly sign clinical trial collaboration and supply agreement for Erbitux® (cetuximab)

Jul 18, 2022

Erasca and Eli Lilly announced that they have entered into a clinical trial collaboration and supply agreement for Erbitux® (cetuximab). This agreement will support Erasca’s ongoing Ph I trials evaluating ERAS-601, its SHP2 inhibitor, with cetuximab for the treatment...

Hikma and Celltrion enter into commercialisation agreement for YuflymaTM

Jul 18, 2022

Hikma Pharmaceuticals announced that it has entered into a commercialisation agreement with Celltrion in relation to Celltrion’s YuflymaTM (biosimilar citrate-free adalimumab). Under the agreement, Hikma will gain exclusive commercialisation rights to YuflymaTM in...

EMA accepts MAA for Polpharma’s biosimilar natalizumab

Jul 15, 2022

Polpharma Biologics announced that the EMA has accepted its MAA for its biosimilar natalizumab for highly active relapsing-remitting multiple sclerosis with the same dosing, presentation and indication as Tysabri®. Polpharma granted Sandoz commercialisation rights to...

Roche publishes eight-year data on Perjeta® based regimen for breast cancer

Jul 14, 2022

Roche reported that eight-year data from its Ph III trials of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy in HER2-positive early breast cancer demonstrates continued benefit of the combination in comparison to trastuzumab and...

Alvotech expands Board of Directors

Jul 14, 2022

Alvotech announced the expansion of its board of directors as part of its transition from private to publicly traded company in June 2022. Alvotech has welcomed four new board members, Lisa Graver, Arni Hardarson, Linda McGoldrick and Ann Merchant, joining existing...

FDA accepts Byondis B.V.’s BLA for [vic-] trastuzumab duocarmazine

Jul 12, 2022

Byondis B.V. announced that the FDA has accepted its BLA for [vic-] trastuzumab duocarmazine (SYD985), a HER2-directed antibody-drug conjugate, for the treatment of patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC), with a...

Overland ADCT commences trials of Zynlonta® in combination with rituximab in DLBCL

Jul 11, 2022

Overland ADCT BioPharma announced the dosing of the first patient in China in its second phase III clinical trials regarding Zynlonta® (loncastuximab tesirine-lpyl, a CD19-directed antibody drug conjugate), this time with rituximab in second-line or later, transplant...

Alvotech commences clinical trials for AVT06 (proposed aflibercept/Eylea® biosimilar)

Jul 7, 2022

Alvotech announced the initiation of its ALVOEYE clinical trials for AVT06, biosimilar to Eylea® (aflibercept) which is indicated for the treatment of adult patients with neovascular (wet) age-related macular degeneration (AMD). AVT06 is the third Alvotech biosimilar...

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Read our latest updates & insights

Green light for patent reform in Australia

Amgen v Hospira: BPCIA dance lessons in the Federal Circuit

TGA seeks input on biosimilar naming in Australia

Recent BioBlast® Updates

Alvotech commences Ph I trials of AVT03 (denosumab) in male subjects

Novartis provides update on Sandoz and earnings data

Poland’s URPL approves IND for Celltrion’s CT-P47 (biosimilar tocilizumab)

J&J report a 53% decrease in Remicade® exports

Erasca and Eli Lilly sign clinical trial collaboration and supply agreement for Erbitux® (cetuximab)

Hikma and Celltrion enter into commercialisation agreement for YuflymaTM

EMA accepts MAA for Polpharma’s biosimilar natalizumab

Roche publishes eight-year data on Perjeta® based regimen for breast cancer

Alvotech expands Board of Directors

FDA accepts Byondis B.V.’s BLA for [vic-] trastuzumab duocarmazine

Overland ADCT commences trials of Zynlonta® in combination with rituximab in DLBCL

Alvotech commences clinical trials for AVT06 (proposed aflibercept/Eylea® biosimilar)

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