Amgen Inc. has swooped on two European cancer specialists, buying Dark Blue Therapeutics Ltd. for up to $840 million plus royalties, and sealing a $618 million license agreement with Disco Pharmaceuticals GmbH for rights to a novel cancer cell surface target.
It’s been a decade since Sandoz Inc. launched Zarxio, referencing Amgen Inc.’s Neupogen (filgrastim), as the first biosimilar in the U.S. Zarxio was expected to be the beginning of a biosimilar boom that would deliver big savings by finally providing direct competition for costly biologics. Neither the pipeline nor the uptake of biosimilars has lived up to expectations, as only 6% of the 313 biologics approved by the FDA’s CDER have been targeted by biosimilars and fewer than 5% are actually competing with the follow-ons.
Ten years after the first biosimilar launched on the U.S. market, the FDA is taking steps to make biosimilar development and pharmacy substitution more like that of generics, reducing the cost of the drugs in the process. “We want to see more biosimilars. We want to see more competition,” FDA Commissioner Marty Makary said at an Oct. 29 media briefing in which he announced new guidance to streamline biosimilar development, cut through the red tape and shorten the timeline.
RAS is the most mutated oncogene in cancer (about 30% rate), where mutations in KRAS are the most prevalent. The approval of covalent KRAS G12C inhibitors has shown allosteric inhibition of KRAS to be a feasible therapeutic strategy, and there is interest in developing new KRAS-directed therapies to target additional KRAS mutants. Amgen has presented data regarding its pan-KRAS inhibitor AMG-410.
Soligenix Inc.’s phase IIa study of SGX-945 (dusquetide) for treating oral ulcers in those with Behçet's disease showed biological efficacy in the proof-of-concept study. The positive results propelled the company’s stock (NASDAQ:SNGX) a hefty 134% higher on July 31, with shares closing at $2.93 each.
In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant and clinically meaningful cuts in low-density lipoprotein cholesterol levels. The PCSK9 inhibitor is looking to fit into a crowded market that already has well-established therapies from other big pharmas and a potential competitor in development to treat another indication.
As biopharma companies continue to roll out their first-quarter earnings, Trump administration tariffs remain at the top of investors’ minds. While executives offer their various strategies to appease concerns, the uncertainty prevails, making it difficult to clearly satisfy all of the questions.
