India

A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.

Sun launches tildrakizumab, its star psoriasis therapy in India seven years after US FDA approval at what’s seen as a carefully calibrated price point. Can it ruffle entrenched products like secukinumab?

India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.

CRDMOs, CDMOs and GCCs are driving partnering and invigorating the wider ecosystem as India moves up the innovation value chain. CRDMOs are moving well beyond traditional outsourcing roles, a new report shows.

Buoyed by the milestone AbbVie deal, Glenmark expects to “pay down” its debt and is also changing certain legacy practices as it seeks to ascend the value chain to become more of a branded company.

Lupin’s launch of liraglutide, a Victoza generic, in the US and tirzepatide development progresses its peptide plans. Meanwhile, pegfilgrastim – nearing US launch - is one of at least five biosimilars to be launched by 2030 amid regulatory easing

Favorable regulatory winds in the US are leading Lupin down the biosimilar path, as it also hopes that the potential US generic-first policy will boost its wider off-patent drug portfolio. However, it is also facing several facility compliance setbacks.

Novo Nordisk’s deal with Emcure for semaglutide will launch Poviztra as a second obesity brand in India, improving access to weight loss treatments following a Lilly-Cipla deal for tirzepatide and seems a clever counter to Indian majors planning to launch generic semaglutide next year

Viatris says initial corrective work at its oral solid dose site in India is “substantially complete” and that it has met with the FDA to discuss next steps following last year’s warning letter and import alert.

Sun’s specialty gambit reaps gains with US sales surpassing generics for the first time in Q2 FY26, but will it finally enter the fray for biosimilars as the US moves to simplify regulatory requirements in the segment?

India is transforming its medtech sector from a consumer-importer market into an innovator-exporter industry. But stakeholders are aware of a public-private investment imbalance, In Vivo notes in part three of its APACMed 2025 conference report.

Cipla’s global CEO and MD Umang Vohra is moving on handing over the baton to global COO, Achin Gupta. Vohra talks about his innings, where he sees Cipla in 2030 and the impact of the latest FDA action that aims to make biosimilar development faster and less costly.