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Celltrion
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

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Merus
NEWS

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

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Key Biosimilars Events of November 2024
INSIGHTS+

Key Biosimilars Events of November 2024

Shots:       Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency        Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients        A major highlight was the EC’s approval of Sandoz’ Afqlir for treating…
December 3, 2024

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Intas & Coherus
NEWS

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

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Biocon Biologics
NEWS

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

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BridgeBio
NEWS

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

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AOP health
INSIGHTS+

AOP Health’s Rapiblyk (landiolol) Receives the US FDA’s Approval for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting 

Shots:    The US FDA has granted approval to Rapiblyk for treating severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter) in critical care setting  Approval was supported by 5 clinical trials assessing the safety & efficacy of Rapiblyk (9.3 to 74.6 mcg/kg/min) vs PBO in adults (n=317) with supraventricular tachycardia, showing 40-90% vs 0-11%…
November 22, 2024

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EMA Marketing Authorization of New Drugs in October 2024
INSIGHTS+

EMA Marketing Authorization of New Drugs in October 2024

Shots:    The EMA’s CHMP has granted positive opinions to 5 Biologics and 1 New Chemical Entity in October 2024, leading to treatments for patients and advances in the healthcare industry   The major highlighted drugs were Novo Nordisk’s Alhemo to treat Haemophilia A or B with inhibitors and AstraZeneca & Ionis’ Wainzua for Hereditary Transthyretin-Mediated Amyloidosis  PharmaShots has…
November 21, 2024

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Pfizer New
NEWS

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

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