Sandoz Group AG

Amgen launches Aflibercept in the US, NICE recommends Outlook Therapeutics’ Bevacizumab for Wet AMD, Amgen secures Denosumab approvals in Australia, Dupixent® approved in EU for children with EoE, Alvotech/Advanz announce EMA acceptance for Golimumab biosimilar, Hims & Hers plans to offer generic Liraglutide in the US, Alteogen partners with Daiichi Sankyo on Trastuzumab deruxtecan, Celltrion launches Ustekinumab biosimilar in EU, Novo Nordisk reports strong financial performance, AstraZeneca’s Fasenra® approved for EGPA in EU, NICE recommends Pfizer’s Elrexfio® for NHS Cancer Drugs Fund, J&J announces positive Ph 3 results for Tremfya®, Celltrion reports positive Infliximab study results, Eli Lilly announces positive results for Ebglyss™, Eisai completes BLA for Leqembi®, TGA updates prescription medicines list, MSD reports Keytruda® sales growth, Novo Nordisk expands Semaglutide use, Sandoz reports strong biosimilars growth.

A New Jersey federal court awarded Sandoz over $70 million in its lawsuit against United Therapeutics for blocking the sale of a generic hypertension drug, finding that Sandoz lost more than $137 million in profits as a result of United Therapeutics breaching a 2015 settlement agreement.

Biosimilars, offering therapeutic benefits at lower costs, have grown significantly, with the global market reaching $26.7 billion in 2023. Favorable regulations and patent expirations fuel this growth, with the US and EU leading. Dominated by companies like Sandoz and Pfizer, the market is projected to exceed $64 billion by 2028.

Sandoz launches first FDA-approved generic paclitaxel formulation for metastatic breast cancer, following approval on Oct. 8, 2024. The lyophilized powder for injection, developed with Jiangsu Hengrui Pharmaceuticals, is indicated for patients with metastatic breast cancer.

Skyrizi sales surpass Humira for the first time in Q3 2024, with Skyrizi sales up 50.8% to $3.205 billion and Humira down 37.2% to $2.227 billion. This shift is attributed to the rise of Skyrizi and Rinvoq, impacting adalimumab biosimilar market share despite their growth.

FDA accepts Organon's aBLA for HLX14, a Prolia®/Xgeva® biosimilar, and Teva's application for its Prolia® biosimilar TVB-009P. Litigations continue between Amgen and biosimilar developers Celltrion, Samsung Bioepis, and Fresenius Kabi. Sandoz's Jubbonti®/Wyost® was approved as interchangeable with Prolia®/Xgeva®.

The FDA accepted Organon and Shanghai Henlius Biotech's BLA for HLX14, a denosumab biosimilar. HLX14 is intended for osteoporosis and bone mass increase in various patient groups. The BLA is supported by comparative quality and clinical studies. Organon has exclusive commercialization rights in the US, EU, and Canada. The FDA approved the first denosumab biosimilars, Wyost and Jubbonti, in March 2024.

The 'Zollinger-Ellison Syndrome (Gastrinoma) - Global Clinical Trials Review, 2024' report by ResearchAndMarkets.com offers a comprehensive overview of clinical trials, including trial numbers, enrollment trends, and sponsor types, aiding in strategic decision-making and competitive advantage.

The 'Zollinger-Ellison Syndrome (Gastrinoma) - Global Clinical Trials Review, 2024' report, available on ResearchAndMarkets.com, offers insights into clinical trials for Zollinger-Ellison Syndrome, including trial numbers, enrollment trends, and sponsor details across regions and countries.

Evotec SE reports Q3 2024 financial results, highlighting strategic progress despite challenging market conditions. Just - Evotec Biologics shows robust growth, and new partnerships with Pfizer, BMS, and Novo Nordisk are established. The Priority Reset initiative aims for over €40m annualised adjusted EBITDA improvement. A new biologics facility in Toulouse, France, is opened, and full-year 2024 guidance is confirmed.