Read our latest updates & insights

The European Commission (EC) has granted Marketing Authorisation for Samsung Bioepis’ Epysqli® (eculizumab), biosimilar to Alexion’s Soliris®.  Epysqli® is approved for the treatment of adult and children patients with paroxysmal nocturnal hemoglobinuria (PNH), and is Samsu...

Chia Tai Tianqing announced that it received a drug registration certificate from China’s National Medical Products Administration for DELITUO® biosimilar to Roche’s Mabthera® (rituximab). It is indicated for treatment of non-Hodgkin’s lymphoma (follicular lymphoma, C...

Roche has announced that it has successfully concluded meetings with pan-Canadian Pharmaceutical Alliance (pCPA) regarding Vabysmo® (faricimab).  The company said that it secured a letter of intent with the pCPA for Vabysmo®, a treatment indicated for neovascular age-relate...

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Adakveo® (crizanlizumab) should no longer be used to prevent painful crises in patients aged 16 years and older with sickle cell disease.  This follows a review by the CHMP, which concluded...

Alnylam commenced  proceedings in the US District Court of Delaware on 26 May 2023 against both Moderna and Pfizer alleging patent infringement over Alnylam’s RNA Lipid Particle Technology encompassed in United States Patent Nos. 11,590,229, 11,633,479, 11,633,480 and 11,61...

The Medicines and Healthcare products Regulatory Agency (MHRA) announced the establishment of new regulatory recognition routes for medicines, utilising approvals from Australia, Canada, the EU, Japan, Switzerland, Singapore, and the US to expedite new product approvals.  T...

Korea Biomed has reported that Celltrion filed a marketing authorisatn application with the EMA for CT-P43, its biosimilar to Janssen’s Stelara® (ustekinemab).  Based on its phase III clinical trial in plaque psoriasis patients, which demonstrated similar efficacy, pharmaco...

The Pharma Letter has reported that the STADA-controlled Norbitec biologics facility in Uetersen, Germany, has been approved by the FDA to manufacture and store Pfizer’s Retacrit® (epoetin alfa-epbx), biosimilar to Amgen’s Epogen®/Procrit®.  The approval followed a six-day ...