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Herceptin Biosimilar, Hercessi, Approved by FDA in Breast, Gastric Cancers

The FDA has approved Hercessi for the adjuvant treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

China , Jason-zhu , Binish-chudgar , European-union , European-commission , Intas-pharmaceuticals , Drug-administration , Henlius-biotech-inc , European-medicines-agency , National-medical-products-administration , Henlius-biotech , Accord-biopharma

FDA Approves Trastuzumab-strf for HER2-Overexpressing Breast and Gastric/GEJ Cancer

The FDA has approved trastuzumab-strf for HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or GEJ adenocarcinoma.

China , Ukraine , United-states , Philippines , Poland , America , Chrys-kokino , Henlius-trastuzumab , Binish-chudgar , Jason-zhu , European-medicines-agency , National-medical-products-administration

Move over, Humira, there's a new mega-blockbuster in town

There was a time not that long ago when Merck & Co. Inc.’s Keytruda (pembrolizumab), with its multiple cancer indications, was seen as the heir apparent to Humira’s title of the biggest blockbuster drug. Not anymore. That title now belongs to Novo Nordisk A/S’ semaglutide, approved as Ozempic in 2017 to treat diabetes and as Wegovy in 2021 to help with weight loss.

Novo-nordisk , Merck-co , Novo-nordiska-s , Semaglutide , Ozempic , Wegovy , Humira , Adalimumab , Keytruda , Merck-amp-co-inc- , Pembrolizumab , Abbvie-inc-

IFX-dyyb Boosts Rheumatoid Arthritis Outcomes in 6 Months

A new study provides insight into the effectiveness of IFX-dyyb in a real-world US population of RA patients, showing how the biosimilar compares to other treatments.

Pennsylvania , United-states , Japan , University-of-pennsylvania , Japanese , Joshuaf-baker , Health-assessment-questionnaire , Drug-administration , University-of-pennsylvania-joshuaf-baker , Perelman-school-of-medicine , Perelman-school

Biosimilars coming into their own in China, despite concerns

The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.

China , Abbvie-inc , Roche-ag , Avastin , Abbvie-inc- , Humira , Pfizer-inc- , Enbrel , Henlius-biotech-inc- , Hanlikang , Mabthera

9 Biosimilars for Intravitreal nAMD, DME Treatment

A number of biosimilar options to treat the common retina diseases are in development globally. Here’s a highlight of 9 with supporting late-stage data.

South-korea , P-biocon-biologics , Aflibercept-eylea-biosimilars , Chong-kun-dang , Ranibizumab-lucentis-biosimilars , Samsung-bioepis , Momenta-pharmaceuticals , Biocon-biologics , Ophthalmology , Biosimilars , Biosimilar , Retina

Data Supports Safety, Efficacy of Biosimilar-to-Biosimilar Switching

The majority of studies evaluating biosimilar-to-biosimilar switching were for rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and ankylosing spondylitis.

United-states , Wolfram-bodenmueller , Hillelp-cohen , Adalimumab-humira , Immunology , Infliximab , Adalimumab , Biosimilar ,

Celltrion Q4 net profit plunges 99.4% on weak sales

Korean biopharmaceutical firm Celltrion said Thursday its fourth-quarter net income plunged 99.4 percent from a year earlier due to sluggish sales.

Seoul , Soult-ukpyolsi , South-korea , Seo-jung-jin , Celltrion-pharm , Celltrion-group , Celltrion-group-chairman-seo-jung-jin , Celltrion-healthcare , Celltrion , Biopharmaceutical , Profit , Company

Teva, Alvotech land approval with edge in Humira biosimilar race

Abbvie Inc.’s blockbuster drug Humira is getting a 10th challenger that could give all the other adalimumab biosimilars a run for their money – depending on pricing and formulary coverage, of course. After delays caused by the COVID-19 pandemic and manufacturing issues, the U.S. FDA approved Simlandi, previously known as AVT-02, as a Humira biosimilar and interchangeable Feb. 23.

Abbvie-inc , Humira , Abbvie-inc- , Adalimumab , Simlandi , Interchangeable , Teva-pharmaceutical-industries-ltd- , Alvotech-holdings-sa , Bioworld , Regulatory , Us-

Humira biosimilar from Alvotech, Teva wins FDA approval on third attempt

The companies didn’t reveal their planned price for Simlandi, which will be the 10th Humira copycat to reach the U.S. market.

Iceland , Samsung-bioepis , Jeffrey-stewart , Boehringer-ingelheim-cyltezo , Amgen-amjevita , Drug-administration-on , Dive-brief , Drug-administration , Teva-pharmaceutical-simlandi , Boehringer-ingelheim , Biopharma-dive , Biosimilar