Responding to questions seeking clarifications over a statement on the scientific rationale supporting the interchangeability of biosimilars in the EU, the EMA has issued a supplementary Q&A document to address issues around multiple switches, complexity of molecular structure and national switching policies.

Teva will not engage in paragraph IV patent-infringement litigation with Evoke Pharma over the originator’s Gimoti (metoclopramide) nasal spray treatment for diabetic gastroparesis, following a court order.

The FDA has published a “Research Roadmap” setting out in detail its areas of interest for the agency’s biosimilar regulatory science pilot program under BsUFA III.

The HHS and CMS have proposed that health plans in the US be required to place generic and brand drugs on the correct tiers for their drug category.

The launch of Amgen’s Amjevita, the first US biosimilar rival to Humira, has been accompanied by multiple fresh forecasts of how competition could play out this year, with a host of further biosimilar launches on the horizon.

In the wake of Amgen announcing a dual pricing strategy for its debut US adalimumab biosimilar – with the firm’s newly-launched Amjevita version being offered at both 5% off and 55% off the WAC of the Humira original – investors and analysts were keen to press the firm for further details of its pricing strategy.

Teva will not engage in paragraph IV patent-infringement litigation with Evoke Pharma over the originator’s Gimoti (metoclopramide) nasal spray treatment for diabetic gastroparesis, following a court order.

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Generics Bulletin looks back at a selection of the most significant legal stories from 2022, including a major victory in the UK on the Eliquis blood thinner giant and continued action on generic label carve outs, which has the potential to reverberate through the US industry.

The launch of Amgen’s Amjevita, the first US biosimilar rival to Humira, has been accompanied by multiple fresh forecasts of how competition could play out this year, with a host of further biosimilar launches on the horizon.

IQVIA’s latest Global Use of Medicines report demonstrates the impact generics and biosimilars are set to have on global pharmaceutical spending, with losses of exclusivity expected to dampen spending growth over the next five years.

Rising inflation has exacerbated pressures in the off-patent drug sector, prompting Medicines for Europe and the US Association for Accessible Medicines to call for regulatory intervention to ensure the long-term sustainability of the space.