The Sept. 4, 2015, at-risk launch of Sandoz Inc.’s Zarxio as the first biosimilar to hit the U.S. market came several months after the FDA had approved the filgrastim biosimilar due to a court battle over the requirements of the 2010 Biologics Price Competition and Innovation Act, which laid out the rules of the road for the new class of follow-on drugs. Ten years later, biosimilar developers are still struggling with some of those rules that were drafted by Congress in an effort to balance competition with innovation in the biologics space. Insulin biosimilars may be the hardest hit.

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.