Herceptin
China approves its first biosimilar of Roche’s Herceptin in HER2+ cancers
August 18, 2020Manufacturing and Production, Sales and Marketing China, Henlius, Herceptin, Roche, biosimilar
China’s National Medical Products Administration (NMPA) has given the green light to Shanghai’s Henlius for its biosimilar version of Roche’s …
Roche’s subcutaneous Perjeta/Herceptin combo proves non-inferior to IV formulation in HER2-positive early breast cancer
December 12, 2019Research and Development Cancer, Herceptin, Perjeta, Roche, breast cancer, pharma
New Phase 3 data from Roche has shown that its subcutaneously-delivered formulation of Perjeta (pertuzumab) and Herceptin (trastuzumab), in combination …
FDA approves third Herceptin biosimilar with Samsung Bioepis’ Ontruzant
January 22, 2019Manufacturing and Production, Sales and Marketing FDA, Herceptin, Samsung Bioepis, biosimilar, pharma
Samsung Bioepis’ has announced that the FDA has chosen to approve Ontruzant (trastuzumab-dttb), its biosimilar version of Roche’s Herceptin (trastuzumab), …
Celltrion and Teva’s Herceptin biosimilar secures FDA approval in breast cancer
December 18, 2018Manufacturing and Production, Sales and Marketing Herceptin, Herzuma, Teva, celltrion, pharma
Israeli and South Korean-based drug makers Teva and Celltrion are set to move in on the market share occupied by …
Pfizer notches two EU approvals, including Herceptin biosimilar
August 1, 2018Research and Development, Sales and Marketing Cancer, EMA, EU, Genetech, Herceptin, Pfizer, Trazimera, Xeljanz, biosimilar, breast cancer, pharma
Pfizer is patting itself on the back after securing two new approvals in Europe within 24 hours: Xeljanz (tofacitinib citrate) …
Study finds Herceptin use can be halved
May 17, 2018Medical Communications, Research and Development Herceptin, Roche, biosimilars, biotech, drugs, pharma, pharmaceutical
A team of researchers from the University of Cambridge and Warwick Clinical Trials have revealed that Roche’s Herceptin is just …
EMA’s CHMP backs Roche’s Perjeta combo in HER2-positive breast cancer
April 30, 2018Sales and Marketing Cancer, Herceptin, Perjeta, Roche, breast cancer, pharma
Roche’s Perjeta has edged one step closer to approval as a combo therapy after the EMA’s Committee for Medicinal Products …
Top Ten most popular articles on Pharmafile.com this week
March 9, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AbbVie, Biogen, Celgene, EMA, Gilead, HIV, Herceptin, Japan, NHS, Ontruzant, Sanofi, opioid crisis, opioids, pharma, real world data, top ten, zinbryta
After a particularly jarring bout of cold weather and snow, we may just have seen off the worst of winter …
Ontruzant launches to become first Herceptin biosimilar available in the UK
March 8, 2018Sales and Marketing Cancer, Herceptin, MSD, Ontruzant, Roche, Samsung Bioepis, pharma
Ontruzant, the biosimilar version of Herceptin (trastuzumab ) originally developed by Korean firm Samsung Bioepis, has launched for patients in …
Celltrion’s Herceptin biosimilar seals EU approval
February 15, 2018Sales and Marketing EU, Europe, Herceptin, Herzuma, celltrion, pharma
Herzuma, Celltrion’s biosimilar version of Roche/Genentech’s blockbuster immunotherapy Herceptin, has been awarded approval from the European Commission, the company has …
Mylan and Biocon biosimilar approval expands to Brazil
January 2, 2018Manufacturing and Production, Sales and Marketing Biocon, Herceptin, Mylan, biosimilar, biotech, drugs, pharma, pharmaceutical
Since Mylan and Biocon managed to gain US FDA approval for its Herceptin (Trastuzumab) biosimilar, it has forged ahead in …
FDA grants breast cancer approval to Roche’s Perjeta/Herceptin combo therapy
December 21, 2017Sales and Marketing Cancer, FDA, Herceptin, Perjeta, Roche, breast cancer, pharma
Roche has announced that the FDA has granted approval to Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and a (Perjeta-based) …
Mylan’s Ogivri becomes first and only FDA-approved Herceptin biosimilar
December 4, 2017Sales and Marketing Biocon, Cancer, FDA, Herceptin, Mylan, Roche, biosimilar, pharma
The FDA has announced the approval of Mylan’s Ogivri (trastuzumab-dkst), the first biosimilar version of Roche’s Herceptin to be authorised …
Samsung Bioepis’ Ontruzant becomes first Herceptin biosimilar approved in Europe
November 20, 2017Sales and Marketing EMA, Herceptin, Roche, Samsung Bioepis
Samsung Bioepis has announced that Ontruzant, the company’s biosimilar version of Roche’s Herceptin, has been awarded marketing authorisation in Europe …
FDA awards Roche priority review in HER2-positive breast cancer
October 2, 2017Sales and Marketing Cancer, FDA, Herceptin, Perjeta, Roche, breast cancer, pharma, pharmaceutical
Roche has revealed that its monoclonal antibody Perjeta (pertuzumab) has been awarded priority review by the FDA as an adjuvant …
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