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Recent BioBlast® Updates

Approval Alert: FDA Approves Sandoz’s Aflibercept Biosimilar

Aug 12, 2024

On 12 August 2024, Sandoz announced that the FDA has approved Enzeevu™ (aflibercept-abzv) biosimilar to Regeneron’s Eylea® for nAMD. Enzeevu™ is the fourth aflibercept biosimilar to be approved in the US, following Samsung Bioepis’ Opuviz™/SB15 (May 2024), Biocon’s...

Celltrion’s Pembrolizumab Biosimilar to Enter Global Ph 3 Trial

Aug 12, 2024

On 12 August 2024, Celltrion announced that the FDA has approved its phase 3 clinical trial plan for CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab). The global phase 3 trial will evaluate the effectiveness of CT-P51 and its and equivalence with Keytruda® in...

Xbrane Out-Licensing Nivolumab and Certolizumab Biosimilars

Aug 12, 2024

On 12 August 2024, Xbrane reported that it has commenced processes to out-license Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801), biosimilar to UCB’s Cimzia® (certolizumab pegol). The out-licensing process is to...

Sandoz Reports Q2/24 and Half Year Financial Results – 37% Biosimilar Growth

Aug 9, 2024

On 9 August 2024, Sandoz announced its Q2 2024 sales and financial results for half year ended 30 June 2024, reporting net sales of USD 2.6 billion for Q2/24, an increase of 9% when compared to the same quarter in 2023. Net sales for biosimilars in the same period...

Celltrion’s Zymfentra™ (SC Infliximab) Listed on 26 US Formularies Five Months Post Launch

Aug 9, 2024

On 9 August 2024, Celltrion announced that its Zymfentra™ (infliximab-dyyb) has been included in 26 US formularies, including for 3 major Prescription Benefit Managers (PBMs), just five months after launch. According to Celltrion, the formulary listings provide 75%...

NZ’s Pharmac Announces Future Procurement Opportunity for Bevacizumab

Aug 9, 2024

On 9 August 2024, New Zealand’s Pharmaceutical Medicines Agency (Pharmac) announced that it is seeking commercial bids from suppliers for the supply of bevacizumab for a range of cancers. Bevacizumab is currently funded in NZ hospitals for recurrent respiratory...

MSD to Acquire Bispecific Antibody Targeting B-Cell Associated Diseases from Curon Biopharmaceutical

Aug 9, 2024

On 9 August 2024, MSD and Curon Biopharmaceutical announced the MSD acquisition of Curon developed CD3xCD19 bispecific antibody CN201, currently in Ph I/II trials for the treatment of B-cell associated diseases. Under the agreement, MSD will make an upfront payment...

Ono and BMS Apply for Approval of Opdivo® and Yervoy® Combination for HCC in Japan

Aug 9, 2024

Ono Pharmaceutical and Bristol-Myers Squibb have announced a supplemental application in Japan for Ono’s Opdivo® and BMS’s Yervoy® in combination therapy, to expand its approved use to the treatment of unresectable hepatocellular carcinoma (HCC). Ono’s 2011 grant to...

Biocon Reports 30% YOY Revenue Growth for Q2/24, Biosimilars Up 11%

Aug 8, 2024

On 8 August 2024, Biocon Limited reported year on year consolidated revenue growth of 30% for Q2 2024, primarily as a result of a “one-time gain” from the strategic collaboration between Biocon and Eris Lifesciences announced in March 2024. Although revenue for...

Fresenius Withdraws Adalimumab Biosim from AU Market

Aug 7, 2024

Fresenius Kabi has walked away from the Australian adalimumab market and cancelled its approvals for 40mg Idacio® pre-filled syringe and 40mg Idacio® pen products which were approved as biosimilars to AbbVie’s Humira®. The withdrawals are listed on the TGA Medicines...

Novo Nordisk Profits Soar in 2024 Mid-Year Report

Aug 7, 2024

On 7 August 2024, Novo Nordisk released its financial report which showed a strong increase in profits in the first half of 2024. Novo Nordisk's total sales equalled DKK 133.4 billion in the first six months of 2024, an increase of 24% in DKK and 25% when measured...

Chugai In-Licenses Anti-TL1A Antibody RG6631 from Roche

Aug 7, 2024

Chugai announced that it has concluded a license agreement with Roche for Roche’s pipeline product RG6631, an anti-TL1A antibody, in late-stage product development for ulcerative colitis and Crohn’s disease. Under the agreement, Chugai, which is 62% owned by Roche,...