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.
Postera Inc. has announced a multitarget collaboration with Amgen Inc. that seeks to leverage Postera’s artificial intelligence (AI) platform, Proton, an innovation in generative chemistry and synthesis-aware design, and Amgen’s drug discovery expertise, to advance up to five small-molecule programs.
What’s it going to take for Australia’s biotech industry to be more self-sufficient? Although Australia is far away from the rest of the world, no one is an island when it comes to biotechnology, Ausbiotech CEO Lorraine Chiroiu said during the Ausbiotech 2023 conference held in Brisbane Nov. 1-3. Investors gathered to riff about what they were looking for in Australian biotech investments and what needs to change for the sector to be sustainable. All agreed that the science in Australia is top-notch but that the ecosystem needs more investment to be competitive.
What’s it going to take for Australia’s biotech industry to be more self-sufficient? Although Australia is far away from the rest of the world, no one is an island when it comes to biotechnology, Ausbiotech CEO Lorraine Chiroiu said during the Ausbiotech 2023 conference held in Brisbane Nov. 1-3. Investors gathered to riff about what they were looking for in Australian biotech investments and what needs to change for the sector to be sustainable. All agreed that the science in Australia is top-notch but that the ecosystem needs more investment to be competitive.
Instead of the two-step process that’s been the typical path for interchangeables in the U.S., Amgen Inc.’s Wezlana got a green light Oct. 31 from the FDA as both the first approved biosimilar and interchangeable to Johnson & Johnson’s inflammatory disease drug, Stelara (ustekinumab).
More layoffs are coming at Amgen Inc., which said it plans to cut about 350 positions from newly acquired Horizon Therapeutics plc. The announcement marks the company’s third round of cutbacks for 2023, following 300 employees in January and another 450 in March, and comes a few weeks after closing on the $27.8 billion buyout.
Harpoon Therapeutics Inc. provided updated interim monotherapy data from 71 patients in its phase I/II trial testing HPN-328 in small-cell lung cancer (SCLC) and other neuroendocrine tumor types in a poster at the European Society of Medical Oncology Congress (ESMO). Wall Street immediately began comparing the compound, which takes aim at delta-like ligand 3 (DLL3) with a similar prospect from Amgen Inc. that recently yielded promising results.
Biopharma companies and industry advocates received the message the U.S. FTC intended to send when it broke new antitrust ground earlier this year in challenging Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc. Now they’re uniting to send a message of their own – in the guise of an awareness campaign showing that the FTC’s new approach to M&A reviews and antitrust enforcement will undermine the ecosystem responsible for innovative and important therapies the world over.
The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
Bad news for Amgen Inc. could mean upside for Mirati Therapeutics Inc., though the meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) has yet to tell the tale regarding Lumakras (sotorasib), the former’s KRAS-G12C inhibitor.
