“The principles of fairness in procedural conduct, especially in commercial disputes, is crucial,” Delhi’s High Court told Zydus Lifesciences as it agreed to temporarily block the sale of the firm’s recently launched biosimilar to Roche’s Perjeta.

Two major Indian players have formed an alliance to bring a biosimilar to Genentech’s Perjeta to their local market, having already debuted several treatments in the HER2-positive breast cancer space.

Leaders from India’s top drug makers discuss efforts to operationalize a world-class skilling institute, backed by tie-ups with organizations like the PDA, ISPE and also taking a leaf out of the automobile industry’s book to build supply chain resilience. They also exuded confidence on moving up the innovation value chain.

US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.