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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...

On 22 July 2025, Replimune announced that the FDA has advised it is unable to approve, in its present form, the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma. The ...

With a number of biosimilars to MSD’s Keytruda® (pembrolizumab) currently in clinical trials, we provide the following update on those trials and their status, based on previous reports and the information available to date in the clinicaltrials.gov registry:

Samsu...

On 21 July 2025, Samsung Bioepis published its US Biosimilar Market Report, which has been released every quarter since April 2023.  The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the U...

On 18 July 2025, the Delhi High Court issued a preliminary injunction restraining Zydus Lifesciences from launching its nivolumab biosimilar (ZRC-3276) in India.  The injunction was granted in proceedings brought by BMS alleging Zydus’ Indian launch of its nivolumab biosimi...

In an article dated 18 July 2025, HiT News reported on a hearing in a patent infringement lawsuit filed by Regeneron and Bayer against Sam Chun Dang (SCD) and Optus Pharmaceutical in the Seoul Central District Court.  The lawsuit was filed by Regeneron/Bayer in January 2024...