Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
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.
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
Major contract research development and manufacturing organizations (CDMO) out of Asia are announcing plans to ramp up production and antibody-drug conjugate (ADC) capabilities worldwide.
Major contract research development and manufacturing organizations (CDMO) out of Asia are announcing plans to ramp up production and antibody-drug conjugate (ADC) capabilities worldwide.
Biosimilars grabbed a lot of headlines in 2023, thanks to the biggest U.S. biosimilar launch to date targeting Abbvie Inc.’s mega-blockbuster Humira (adalimumab). Eight biosimilars referencing the immunology drug entered the U.S. market under licensing agreements with Abbvie. Amgen Inc.’s Amjevita led the pack with a five-month headstart in January. The others – including the first adalimumab interchangeable, Boehringer Ingelheim GmbH’s Cyltezo – launched in July.
Samsung Bioepis Co. Ltd. will partner with South Korean biotech Intocell Inc. to develop antibody-drug conjugate (ADC) drugs, continuing the Samsung Group and the wider industry’s hunt for novel ADCs. Under the joint research agreement inked on Dec. 5, the Daejon-based ADC platform technology firm Intocell will supply the Songdo, Incheon-based Samsung Bioepis its linker technology, coined OHPAS, or ortho-hydroxy protected aryl sulfate, upon which Samsung Bioepis will develop ADC drugs for up to five cancer targets.
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
As South Korea increases its stakes on the “bioeconomy” as its next growth engine and as its “second semiconductor industry,” leading domestic biologic and biosimilar drug producers such as Samsung Biologics Co. Ltd. and Celltrion Inc. are setting record production targets to become forerunners in the global playing field.
National support for the biosimilar sector and the domestic industry’s efforts to increase production and sales may not be enough for South Korean biosimilar firms to box out competition in the ever-changing regulatory court of the U.S.
