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.

The U.S. FDA cleared 20 drugs in October 2025, up from 17 in September, 18 in August and 17 in July, bringing the year’s total to 181 approvals through the first 10 months. Two new molecular entities (NMEs) gained U.S. approval in October: Boehringer Ingelheim GmbH’s Jascayd and Bayer AG’s Lynkuet.

Biopharma dealmaking activity remained strong in October, with total deal value reaching $31.86 billion, a 17% increase from $27.15 billion in September and ranking as the second-highest month in 2025 after June’s $35.43 billion.

Biopharma companies focused on infectious disease extended their stock recoveries through the third quarter (Q3), with the BioWorld Infectious Disease Index closing October up 28.98%. The gain marks a strong turnaround from earlier in the year, when the index had fallen 17.83% by the end of April before rebounding to a 4.34% gain by July’s close.