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On 25 July 2025, the High Court of Delhi issued an interlocutory judgment in ongoing patent infringement litigation brought by Roche to prevent Zydus from launching Sigrima®, biosimilar to Roche’s Perjeta® (pertuzumab), in India.

One of Roche’s patents in suit, IN464...

On 25 July 2025, Ono Pharmaceutical Co announced the additional approval by the Taiwan Food and Drug Administration (TFDA) of Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as intravenous infusion for first-line treatment of adult patients with unresectable or...

On 25 July 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its July meeting, with positive opinions for the following denosumab, aflibercept and ustekinumab biosimilars:

Shanghai Henlius’ Bildyos...

Roche’s 2025 second-quarter earnings call included disclosure that it now expects biosimilar competition to Perjeta® (pertuzumab) and Xolair® (omalizumab) in 2026, sooner than previously anticipated.

In its previous quarterly earnings call in April 2025, Roche had sa...

On 24 July 2025, Reuters reported that Dr Reddy’s CEO, Erez Israeli, stated the company plans to launch its generic version of Novo Nordisk’s Wegovy® (semaglutide), in 87 countries in 2026, beginning with Canada, India, Brazil, Turkey and other emerging markets, subject to ...

On 24 July 2025, the Patent Trial and Appeal Board (PTAB) instituted an inter partes review (IPR), filed by Amgen in February 2025, challenging the validity of a BMS US patent (US11332529) relating to methods of treating colorectal cancer using nivolumab (Opdivo®) and ipili...

On 23 July 2025, Biocon Biologics announced that it has launched Nepexto®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), in Australia.  Nepexto® was approved by Australia’s Therapeutic Goods Administration in September 2022, and will be supplied by Biocon’s local partn...

On 23 July 2025, Fresenius Kabi announced that the European Commission (EC) has granted approval for Conexxence® and Bomyntra®, biosimilars to Prolia® and Xgeva® (denosumab), for all reference indications.

Conexxence® and Bomyntra® were recommended for approval at th...

On 23 July 2025, Janssen announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation (SC) as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developi...