18 Jul 22 | MENA | Hikma and Celltrion enter into commercialisation agreement for YuflymaTM
Hikma Pharmaceuticals announced that it has entered into a commercialisation agreement with Celltrion in relation to Celltrion’s YuflymaTM (biosimilar citrate-free adalimumab). Under the agreement, Hikma will gain exclusive commercialisation rights to YuflymaTM in all of its Middle East and North Africa (MENA) markets. Hikma has launched a number of Celltrion biosimilars: Truxima® (rituximab), Remsima® (infliximab) and Herzuma® (trastuzumab), with the launch of Remsima® SC (subcutaneous infliximab) in progress.
18 Jul 22 | Erasca and Eli Lilly sign clinical trial collaboration and supply agreement for Erbitux® (cetuximab)
Erasca and Eli Lilly announced that they have entered into a clinical trial collaboration and supply agreement for Erbitux® (cetuximab). This agreement will support Erasca’s ongoing Ph I trials evaluating ERAS-601, its SHP2 inhibitor, with cetuximab for the treatment of triple wildtype metastatic colorectal cancer and HPV-negative advanced head and neck squamous cell carcinoma. Lilly will supply cetuximab to Erasca at no cost.
19 Jul 22 | Poland’s URPL approves IND for Celltrion’s CT-P47 (biosimilar tocilizumab)
Korea Biomedical Review reported that Celltrion has received approval from Poland’s Pharmaceutical and Medical Equipment Registration Office (URPL) for its IND for Ph III trials of CT-P47 (biosimilar to Actemra®, tocilizumab).
19 Jul 22 | Novartis provides update on Sandoz and earnings data
Novartis published its financial results, reporting a 1% decrease USD (5% increase cc) in Q2 2022 sales over Q2 2021, and 3% decrease USD (5% increase cc) for Sandoz sales. Novartis confirmed that its strategic review of Sandoz is on track, and that it would provide an update at the latest, by the end of 2022.
20 Jul 22 | Alvotech commences Ph I trials of AVT03 (denosumab) in male subjects
Alvotech announced that it has initiated a pharmacokinetic study for AVT03 (denosumab, biosimilar to Prolia®/Xgeva®). The study will assess the pharmacokinetics, safety and tolerability of AVT03 compared to Prolia® in healthy adult male subjects.
Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar candidate to Stelara®) for which Alvotech recently announced positive topline results; AVT04 (aflibercept/biosimilar candidate to Eylea®), golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.
21 Jul 22 | US | FDA accepts sBLA for 100mg/mL Hyrimoz®
Sandoz announced that the FDA has accepted its sBLA for a high-concentration citrate-free formulation (100mg/mL) of Hyrimoz® (biosimilar adalimumab). The 50mg/mL formulation of Hyrimoz® was approved by the FDA in 2018 for the treatment of rheumatoid arthritis, juvenile idiopathic arthitis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
Pearce IP offers Australian based life sciences focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance. Call us today on 02 9023 9988 or email info@pearceIP.law.