“New explosions in biotechnology are allowing us to interrogate cancers at a very sophisticated level compared to before,” Dennis Slamon told audience members at the Global Bio Conference in Seoul, South Korea Sept. 3.
“New explosions in biotechnology are allowing us to interrogate cancers at a very sophisticated level compared to before,” Dennis Slamon told audience members at the Global Bio Conference in Seoul, South Korea Sept. 3.
It’s taken nearly a decade for the U.S. FDA to go from zero to 60 in approving biosimilars. Currently, 63 biosimilars have been approved in the U.S., thanks to 18 new approvals in 2024 that stretched the number of biologics referenced by biosimilars from 14 to 17. That’s an all-time record, CDER Director Patrizia Cavazzoni said, as she released the drug center’s annual approval report for 2024.
Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s Herceptin (trastuzumab). The CRL cites unnamed issues that need to be addressed by the downstream manufacturer of TX-05, which is a third-party service provider of Tanvex U.S. for its drug product.
Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s Herceptin (trastuzumab). The CRL cites unnamed issues that need to be addressed by the downstream manufacturer of TX-05, which is a third-party service provider of Tanvex U.S. for its drug product.
With the biggest biosimilar launch in the U.S. just days away, Humira’s (adalimumab) record-breaking ride is quickly slowing down, but the Abbvie Inc. mega-blockbuster immunology drug is nowhere near the end of its road. Meanwhile, the U.S. journey is just beginning for the eight adalimumab biosimilars that could come to market as early as July 1 through licensing agreements with Abbvie. Besides revving their engines against Humira, the new launches will be looking to overtake Amgen Inc.’s biosimilar, Amjevita, which got a five-month headstart in the U.S., thanks to the first-mover status Amgen earned for being the first to sign a licensing agreement with Abbvie.
By using a statin to preferentially increase the expression of HER2 on tumor cells, researchers at Memorial Sloan Kettering were able to sensitize gastric cancers to a HER2-targeted radioligand in animal models of gastric cancer. Lovastatin aided the radioligand via two distinct mechanisms. First, it increased the availability of HER2 on the cell surface, allowing greater binding. It also had radioprotective effects on normal cells, reducing the toxicity of higher doses of radiation.
Targeted radiopharmaceutical specialist Precirix NV has closed an €80 million (US$87.8 million) series B financing, enabling it to complete phase II development of CAM-H2, a potential treatment for HER2-positive metastatic breast cancer and gastric cancer. The round follows initial data showing there were no dose limiting toxicities in the first cohort of patients in the phase I/II trial, and a positive review from the safety committee.
South Africa’s Competition Commission sent a warning this week to the biopharma industry when it announced that it is prosecuting Roche Holding AG for what it called excessive pricing of the company’s breast cancer drug, Herceptin, which is also marketed as Herclon in South Africa.
With the next big wave of biologic patent expirations soon to wash over the U.S. market, companies developing biosimilars are optimistic about the future. “We’re at a place where we’re seeing really strong uptake of biosimilars, which has resulted in cost savings,” Chad Pettit, executive director of marketing for Amgen Inc.’s biosimilars unit, told BioWorld.
