Accord Healthcare Inc

The District Court The Hague dismissed nullity suits from Accord Healthcare and Sandoz against Xtandi's basic patent EP 1 893 196 and its Dutch SPC, maintaining protection until June 2028.

Esperion Therapeutics has reached a settlement agreement with Micro Labs that prevents the generic manufacturer from marketing a version of NEXLETOL (bempedoic acid) before April 19, 2040.

Sakar Healthcare received its second Marketing Authorization from the European Union for an oncology injection product targeting colorectal cancer treatment.

The European Medicines Agency's CHMP has adopted a positive opinion for Accord Healthcare's denosumab biosimilars, Osvyrti® (60mg) for osteoporosis and Jubereq® (120mg) for oncology indications.

• The European Commission has granted marketing authorization for Imuldosa, a biosimilar to Stelara (ustekinumab), for immune-mediated inflammatory diseases. • Imuldosa's approval is based on comprehensive data, including a Phase III trial demonstrating therapeutic equivalence and comparable safety to Stelara in plaque psoriasis patients. • Accord Healthcare plans to launch Imuldosa in the EU, targeting the ustekinumab market valued at approximately €2.9 billion (US$3.18 billion). • Imuldosa, developed in collaboration with Dong-A ST and Meiji Seika Pharma, has also received FDA approval and will be commercialized globally by Intas Pharmaceuticals.

• A study in the _Asian Journal of Surgery_ found that a trastuzumab biosimilar combined with pertuzumab and chemotherapy is effective for HER2-positive breast cancer. • The real-world study reported a total pathological complete response rate of 68.2% and a breast pathological complete response rate of 81.8%. • The combination therapy demonstrated a 100% objective response rate and disease control rate, indicating high efficacy in the studied cohort. • The treatment offers a safe and potentially more affordable alternative to originator trastuzumab for neoadjuvant therapy.