NEWS

Celltrion’s Omlyclo (CT-P39) Secures the Health Canada’s Approval (Biosimilar, Xolair)

Shots: The Health Canada has granted approval to Celltrion’s Omlyclo, a biosimilar version of Xolair (omalizumab) The approval was based on clinical outcomes incl. P-III trial assessing the safety, efficacy & PK/PD of Omlyclo vs Xolair in patients with chronic idiopathic urticaria (CIU) for over 40wks., depicting therapeutic equivalence b/w the drugs Omlyclo (75mg/0.5mL &…

December 9, 2024

Merus Reports the US FDA’s Accelerated Approval of Bizengri (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC

Shots: The US FDA has granted accelerated approval to Bizengri for the treatment of advanced, unresectable or metastatic NRG1+ pancreatic adenocarcinoma or NSCLC. It will be commercialized by Partner Therapeutics in the US under previously signed agreement Approval was based on eNRGy study assessing the safety, tolerability, PK/PD, immunogenicity & anti-tumor activity of zenocutuzumab to…

December 4, 2024

Intas Pharmaceuticals to Acquire Coherus BioSciences’ Udenyca Business (Biosimilar, Neulasta)

Shots: Intas Pharmaceuticals, through its US specialty division Accord BioPharma, has entered into an agreement to acquire Coherus’ Udenyca business (pegfilgrastim-cbqv), a biosimilar of Amgen’s Neulasta, to enhance Accord’s biosimilar product portfolio. Deal is expected to conclude in Q1’25 Udenyca is indicated to reduce infection risk from febrile neutropenia in patients with non-myeloid malignancies,…

December 3, 2024

Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara)

Shots: The US FDA has granted approval to the company’s Yesintek, a biosimilar version of J&J’s Stelara (ustekinumab) Biocon Biologics will commercialize Yesintek across the US by Feb 22, 2025, following FDA approval, under a settlement and licensing agreement with Janssen Yesintek is a monoclonal antibody indicated for the treatment of Crohn’s disease, Ulcerative Colitis,…

December 1, 2024

BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM

Shots: The US FDA has approved Attruby (oral stabilizer of Transthyretin) to reduce cardiovascular death & associated hospitalization in ATTR-CM patients. The MAA is also under review in the EU, with decision anticipated in 2025 Approval was based on P-III (ATTRibute-CM) study of Attruby vs PBO in ATTR-CM patients (n=632). It achieved its 1EP, showing…

November 22, 2024

Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Shots: The EC has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs., at least 35kg) with hemophilia A & B, without FVIII & FIX inhibitors, respectively. It is valid across the EU plus Iceland, Liechtenstein & Norway Approval was based on pivotal P-III (BASIS) study of Hympavzi…

November 20, 2024

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab)

Shots: Xbrane and Intas have entered into a global licensing and co-development agreement for Xbrane's biosimilar of Opdivo (nivolumab). Intas, through its Accord Healthcare, will commercialize the biosimilar, leveraging its oncology expertise and significant market presence in the EU As per the agreement, Intas will fund and manage clinical as well as regulatory development, and…

November 19, 2024

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the EC’s Approval to Treat Platinum-Resistant Ovarian Cancer

Shots: The EC has approved Elahere to treat FRα+, Pt-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments, valid across whole EU plus Iceland, Liechtenstein, Norway & Northern Ireland Approval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT (weekly paclitaxel, pegylated liposomal…

November 18, 2024

Samsung Bioepis and Biogen Report the EC’s Approval of Opuviz (Biosimilar, Eylea)

Shots: The EC has granted approval to Opuviz 40 mg/mL solution, biosimilar version of Eylea (aflibercept) and will be commercialized by Biogen as per an agreement b/w the companies Approval of SB15 was based on comprehensive data, incl. a P-III study showing equivalent efficacy, safety, immunogenicity & PK profile to aflibercept. It achieved the 1EP…

November 18, 2024

Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of Ahzantive/Baiama/FYB203 (Biosimilar, Eylea)

Shots: The CHMP has recommended FYB203 under the brand names, Ahzantive/Baiama, biosimilar version of Eylea (aflibercept), with the decision anticipated in 2nd half of Jan’25 The approval, if granted, will be valid across the whole EU, as well as in Iceland, Liechtenstein & Norway. It is already approved across the US in Jun 2024 FYB203…

November 18, 2024

NEWS

Celltrion’s Omlyclo (CT-P39) Secures the Health Canada’s Approval (Biosimilar, Xolair)

Merus Reports the US FDA’s Accelerated Approval of Bizengri (Zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NSCLC

Intas Pharmaceuticals to Acquire Coherus BioSciences’ Udenyca Business (Biosimilar, Neulasta)

Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara)

BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM

Pfizer Reports the EC’s Approval of Hympavzi (Marstacimab) to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab)

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the EC’s Approval to Treat Platinum-Resistant Ovarian Cancer

Samsung Bioepis and Biogen Report the EC’s Approval of Opuviz (Biosimilar, Eylea)

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