United States

Biotech’s pricing playbook is being upended as US Most-Favored Nation rules collide with Europe’s evolving International Reference Pricing models. The result: launch strategies, deal structures and innovation pipelines are all under pressure.

A Teva official suggested the increasing reliance on analytical characterizations rather than clinical studies to show biosimilarity should warrant user fee structure changes.

In a busy year for US biosimilars, more than a dozen approvals were seen as multiple brands faced competition for the first time – including Stelara. However, concerns persist over the “biosimilar void”, with hope that the latest FDA announcement on regulatory streamlining can help to fill the gap.

Alvotech and Teva have become the latest Eylea biosimilar developers to announce a settlement allowing a US launch in late 2026. However, first they must clear the hurdle of FDA approval following a recent CRL.

Generics Bulletin reviews global regulatory developments across the world.

MediNatura expands recall to include all lots of both ReBoost and ClearLife nasal sprays after microbial contamination and yeast or mold were found. Firm in 2021 challenged homeopathic drug oversight change from policy in place since 1988.

The FDA rejection of Alvotech’s AVT06 Eylea biosimilar was revealed as part of a wider funding update outlining a $108m bond placement and continued heavy R&D investment.

“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.

Civica has been cleared to supply essential generic medicines across the US veterans health system under a federal supply schedule agreement.

After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.

“We have rarely, if ever, enforced this requirement” FDA says announcing enforcement discretion regarding requirement for disclaimer about supplement structure/function and other label claims to be printed on every panel of a product’s package.

After multiple warning letter campaigns, the US FTC has claimed a win as Teva’s request to remove hundreds of Orange Book patent listings will pave a generic competition path for more than 30 products.