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Sanofi-Aventis filed one of the earliest UPC revocation cases against Amgen’s Repatha® (evolocumab) patent EP3666797 in Munich on 1 June 2023, the day of the UPC’s commencement. Evolocumab is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin t...

The FDA announced that it has approved AstraZeneca’s Lynparza® (olaparib) with abiraterone and prednisone (or prednisolone) for patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved ...

Celltrion has released its clinical phase I data for its tocilizumab product CT-P47, biosimilar to Roche’s Actemra® which it announced at the 2023 European Congress of Rheumatology (2023 EULAR).  Celltrion has successfully demonstrated pharmacodynamic equivalence and safety...

BMS announced that the FDA accepted its New Drug Application for repotrectinib, a tyrosine kinase inhibitor for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).  The FDA granted the application Priority Review and a decision ...

Lupin announced a strategic collaboration with Enzene Biosciences (Aklem Laboratories’ biological arm) to launch Cetuxa®, the first Indian biosimilar cetuximab for Eli Lilly and Merck KGaA’s Erbitux®.  Cetuximab is approved by Drug Controller General of India for trea...

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...