Against a backdrop of continued outcry over insulin costs in the US and the looming FDA-imposed transition of insulins to biologic status in early 2020, legislators and manufacturers alike are still lobbying for alternative approaches to the essential diabetes treatment.

Torrent has been told to conduct a comprehensive review of its global manufacturing operations by the US Food and Drug Administration, as the agency sent a warning letter to the Indian firm over its local manufacturing facility in Indrad, Gujarat.

Sandoz has announced that partner Pear Therapeutics will now market alone the reSET and reSET-O digital therapeutics launched by the pair in the US almost a year ago. The move follows Richard Saynor taking charge of Sandoz as part of the Novartis unit’s current transformation.

France is seeking to tackle the originator tactic of using low prices for biologic brands in hospitals to snare patients and keep them on the same product once they transition to outpatient care, where prices are much higher.

France is seeking to tackle the originator tactic of using low prices for biologic brands in hospitals to snare patients and keep them on the same product once they transition to outpatient care, where prices are much higher.

In this podcast discussion, Generics Bulletin’s David Wallace talks to Informa Pharma Consulting’s Duncan Emerton about Celltrion’s CHMP nod for subcutaneous Remsima, the product’s imminent approval and launch, and what it means for the future of biosimilars.