US Congress moves to dismantle biosimilar barriers, raising hopes for Korean biotech

The US legislature has passed a series of bills aimed at dismantling patent barriers erected by global pharmaceutical companies and making biosimilar (biopharmaceutical copies of brand-name drugs) market entry significantly easier.

The legislation targets unchecked patent abuse by originator drug manufacturers while streamlining clinical trial and interchangeability approval procedures — developments widely expected to benefit South Korean pharmaceutical and biotech companies, which lead the global biosimilar market.

According to the Korea Bioindustry Association's Bio-Economy Research Center, the US Senate on Tuesday unanimously passed the Affordable Prescriptions for Patients Act, designed to prevent originator drug manufacturers from building so-called "patent thickets."

The bill caps at 20 the number of patents an originator pharmaceutical company may assert in patent infringement litigation against a biosimilar developer. Of those 20 patents, no more than 10 may be continuation patents filed after the original drug received approval.

The measure targets a long-standing practice in which originator companies have deliberately delayed biosimilar market entry by filing dozens or even hundreds of continuation patents in piecemeal fashion after initial approval.

On the same day, the House Energy and Commerce Committee unanimously advanced two bills that would substantially ease biosimilar approval and distribution regulations, accelerating the legislative process. The Biosimilar Accessibility Act, which cleared the standing committee, would eliminate requirements to conduct pharmacokinetic, immunogenicity and comparative clinical efficacy evaluations that had been mandatory when applying for biosimilar approval. The change is expected to significantly reduce the burden of large-scale Phase 3 trials previously required to demonstrate equivalence with the originator drug.

A second bill, the Biosimilar Deregulation Act, would eliminate the legal distinction between standard biosimilars and "interchangeable" biosimilars — those eligible for pharmacy-level substitution — and require the FDA to automatically grant interchangeability status upon approval. This would allow pharmacists to substitute a biosimilar for the originator drug at their discretion, without the biosimilar having to undergo a separate clinical trial.

Both bills have drawn bipartisan support in the Senate and the House, and analysts consider final enactment within the year highly likely. The moves signal a sweeping regulatory overhaul by the US government and Congress aimed at lowering domestic drug prices and improving patient access to medicines.

The policy shift is seen as a major opportunity for South Korean biotech companies, whose technological capabilities have earned recognition in global markets.

Most immediately, the changes are expected to dramatically cut development timelines and costs. Easing the comparative Phase 3 trial requirement — historically the most time-consuming and expensive stage of biosimilar development, often running into hundreds of billions of won — would accelerate pipeline development and sharply improve price competitiveness.

The legislation would also remove the uncertainty caused by deliberate patent litigation by originator companies that has delayed product launches. Automatic interchangeability recognition is expected to help leading South Korean biosimilar makers Samsung Bioepis and Celltrion establish themselves more quickly in the US market and expand their share with pharmacy benefit managers and other distribution-channel players.