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Biogen, Genentech and Roche instigated proceedings against Dr Reddy’s Laboratories and Fresenius Kabi, alleging infringement of 15 patents relating to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) products in the US District Court of New Jersey.  The alleged infringemen...

EirGenix announced that Herwenda®, Eirgenix and Sandoz’s biosimilar to Genentech’s Herceptin® (trastuzumab), received approval from the European Commission for the same indications as Herceptin®: HER2-positive breast cancer and metastatic gastric cancers.  On 30 April 2019,...

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) against Regeneron’s Eylea® (aflibercept) patent no. 11,253,572 in IPR proceeding IPR2023-00884.  The ‘572 patent relates to methods of use of aflibercept in treating angiog...

AstraZeneca (AZ) announced the FDA approved its Truqap® (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker a...

Korea Biomed reported that AbbVie’s Skyrizi® (risankizumab) has been approved by the Korean Ministry of Food and Drug Safety (MFDS) for a new indication: to treat adult patients with moderate to severe active Crohn’s disease who have not responded adequately to or can...

MSD announced that the FDA approved its Keytruda® (pembrolizumab) combined with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-ne...

The French Parliament is debating 2024 budget reform (Social Security Financing Bill for 2024) which would enable pharmacists to substitute originator biologic products with biosimilars two years after the launch of the biosimilar.  Under proposed amendments 1156, 2415 and ...

Bristol Myers Squibb (BMS) announced the FDA approved its Augtyro® (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).  

On 30 October 2023, FDA approved BMS’s supplemental biologic...

The Korea Herald reported that Samsung Bioepis has received approval from the Ministry of Food and Drug Safety for a phase I clinical trial of SB27, a biosimilar to Merck’s anti-PD-1 therapy Keytruda® (pembrolizumab).  Samsung appears to be ahead of several other companies ...