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NEWS

Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 

  Shots:  The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025  The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from…
September 18, 2024

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Accord Healthcare
NEWS

Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 

Shots:  The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025  The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from the…
September 18, 2024

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Roche
NEWS

Roche Reports the US FDA’s Approval of Ocrevus Zunovo for Treating Relapse and Progressive Multiple Sclerosis 

Shots:     The US FDA has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq), a twice-a-year, 10-minute SC injection, to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)  The approval was supported by the pivotal P-III (OCARINA) study assessing the PK, safety, clinical & radiological efficacy of the Ocrevus SC vs IV in patients (n=236)…
September 13, 2024

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Eli Lilly
NEWS

Eli Lilly’s Ebglyss (Lebrikizumab-lbkz) Receives the US FDA’s Approval for Treating Moderate-to-Severe Atopic Dermatitis 

Shots:     The US FDA has approved Ebglyss to treat moderate-to-severe AD in adults & children (≥12yrs.) weighing 88 pounds (40kg). Lilly holds its exclusive rights outside the EU, while Almirall has licensed rights in the EU  The approval was supported by P-III (ADvocate 1 & 2) studies of Ebglyss alone and P-III (ADhere) study of…
September 13, 2024

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Roche
NEWS

Roche’s Tecentriq Hybreza Receives the US FDA’s Approval for Cancer Treatment 

  Shots:    The US FDA has approved Tecentriq Hybreza (SC) to treat all IV indications, incl. lung, liver, skin & soft tissue cancers. Regulatory reviews across other regions are underway  The approval was supported by P-IB/III (IMscin001) study assessing Tecentriq Hybreza (SC) vs Tecentriq (IV) in locally advanced or metastatic NSCLC patients (n=371) failed on…
September 13, 2024

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Insights+ Key Biosimilars Events of August 2024
INSIGHTS+

Insights+ Key Biosimilars Events of August 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       The major highlights were the US FDA’s approval of Sandoz’s Enzeevu for Treating Neovascular Age-Related…
September 3, 2024

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NEWS

The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors

Shots:  The NMPA has cleared IND application of HLX17 to conduct its clinical study in comparison with Keytruda for treating melanoma, NSCLC, esophageal cancer, HNSCC, CRC, HCC, biliary tract cancer, TNBC, MSI-H/dMMR cancer & gastric cancer   HLX17 was assessed under pharmacologic comparative trial, preclinical pharmacology study as well as PK/PD & immunogenicity studies that showed similarity…
September 2, 2024

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Roche
NEWS

Roche’s PiaSky Receives the EC’s Approval to Treat Paroxysmal Nocturnal Haemoglobinuria (PNH) 

Shots:    The EC has granted approval to PiaSky (crovalimab) for treating PNH in adults & adolescents (≥12yrs., weight: ≥40kg) who are either treatment-experienced or treatment-naïve  Approval was based on P-III (COMMODORE 2) trial assessing PiaSky vs eculizumab in PNH patients not treated with C5 inhibitors plus results from another P-III trials, COMMODORE 1 (PNH patients…
August 27, 2024

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Celltrion
NEWS

Celltrion’s SteQeyma (Biosimilar, Stelara) Receives the EC’s Approval to Treat Various Chronic Inflammatory Diseases 

Shots:  Following the CHMP’s positive opinion in Jun 2024, the EC has approved SteQeyma, a biosimilar version of Stelara (ustekinumab), for treating various chronic inflammatory diseases. Approved as biologic for gastroenterology, dermatology & rheumatology indications  Approval was supported by the P-III trial of SteQeyma vs Stelara for moderate to severe plaque PsO, with 1EP as…
August 26, 2024

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