mAbxience and Sandoz Partner to Advance Emicizumab Biosimilar Access Globally

Shots: mAbxience & Sandoz have entered into a licensing, development, manufacturing & commercialization agreement for an emicizumab biosimilar candidate As pe the deal, mAbxience will develop & manufacture the biosimilar at its GMP-approved facilities in Spain & Argentina, while Sandoz will hold exclusive global commercialization rights (excl. Argentina, Uruguay & Paraguay); financial terms remain confidential…

ByRidhi Rastogi6 hours ago

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Samsung Bioepis Reports MHLW Approval of its Ustekinumab Biosimilar

Shots: The MHLW has granted marketing approval to Ustekinumab BS IV infusion 130mg 「NIPRO」, a biosimilar version of Stelara (ustekinumab), for induction therapy in mod. to sev. active Crohn’s disease when other treatments are ineffective Additionally, the MHLW approved Ustekinumab BS SC Injection 45mg Syringes 「NIPRO」in Dec 2025, which was then launched in May 2026 The biosimilar…

ByRidhi RastogiSeptember 4, 2026

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Cipla Partners with Qilu Pharmaceutical to Commercialize QL2107 (Biosimilar, Keytruda) in the US

Shots: Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, has entered into a strategic partnership with Qilu Pharmaceutical for the exclusive licensing & supply of QL2107, a biosimilar version of Keytruda (pembrolizumab), for the US As per the deal, Qilu will handle product development, regulatory registration & supply, while Cipla USA will commercialize the asset across the…

ByRidhi RastogiSeptember 4, 2026

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Alvotech Reports US FDA BLA Acceptance for AVT80 (Biosimilar, Entyvio)

Shots: The US FDA has accepted a BLA for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) PFS & autoinjector for SC administration BLA was backed by analytical, PK & immunogenicity data, showing biosimilarity with the reference product. Plus, under a partnership with Teva, Alvotech is responsible for development & manufacturing of AVT80, while Teva…

ByRidhi RastogiAugust 31, 2026

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Celltrion Reports Launch of Omlyclo 300mg (Biosimilar, Xolair) in Europe

Shots: Celltrion has reported the launch of Omlyclo (300mg in PFS & autoinjector), a biosimilar version of Xolair (omalizumab), for the treatment of pts with allergic asthma & chronic spontaneous urticaria (CSU) in Europe Following the EU launch of Omlyclo 75mg & 150mg last year, Celltrion began rolling out the 300mg dose in Germany, the…

ByRidhi RastogiAugust 25, 2026

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Alvotech and Lotus Partner to Commercialize AVT34 (Biosimilar, Imfinzi) and AVT87 (Biosimilar, Hemlibra) Across the US and 8 Asian Countries

Shots: Alvotech has entered a strategic licensing & commercialization agreement with Lotus Pharmaceutical for AVT34, a proposed Imfinzi (durvalumab) biosimilar, & AVT87, a proposed Hemlibra (emicizumab) biosimilar, in the US & selected Asian markets Under the US semi-exclusive deal, Alvotech & Lotus will jointly commercialize AVT34 and AVT87, with Lotus commercializing the products through Alvogen;…

ByRidhi RastogiAugust 24, 2026

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Henlius and Sandoz Partner on Up to 10 Biosimilar mAbs and ADC Products

Shots: The deal incl. ~10 biosimilars or related components, incl. 3 initial assets: HLX05-N (cetuximab), HLX16 (evolocumab), & a proposed belimumab biosimilar, plus an option for HLXTE-HAase1001, a recombinant human hyaluronidase Sandoz will receive exclusive rights to register & commercialize the assets globally outside China, with both parties sharing development & lifecycle activities. Territories vary…

ByRidhi RastogiAugust 17, 2026

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Samsung Bioepis Launches Opuviz 40 mg/mL PFS (Biosimilar, Eylea) in the EU

Shots: Samsung Bioepis has reported the commercial launch of Opuviz 40 mg/mL solution (PFS), a biosimilar version of Eylea (aflibercept) across the EU Opuviz (aflibercept) is a VEGF inhibitor that blocks abnormal blood vessel growth and leakage in the eye. Samsung Bioepis launched the 40 mg/mL vial in May’26. The PFS formulation received a positive CHMP opinion in Nov’25 for the same indications Opuviz 40…

ByRidhi RastogiAugust 10, 2026

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Biocon Launches Yesafili (Biosimilar, Eylea) in the US

Shots: Biocon has reported the commercial launch of Yesafili, a biosimilar version of Eylea 2mg (aflibercept), in the US, which was previously approved & granted interchangeable designation In the P-III (INSIGHT) study in Diabetic Macular Edema (DME), Yesafili showed no clinically meaningful differences from Eylea in PK, safety, efficacy, or immunogenicity Yesafili is a VEGF inhibitor…

ByRidhi RastogiAugust 4, 2026

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Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)

Shots: The US FDA has approved Garzulys (SC & IV), a biosimilar to NovoLog (insulin aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus Garzulys was developed through a collaboration among Tonghua Dongbao, NKF, Xentria, Meitheal, & Emerge. Tonghua Dongbao developed the drug substance, NKF the drug product, Xentria led clinical…

ByRidhi RastogiAugust 3, 2026

mAbxience and Sandoz Partner to Advance Emicizumab Biosimilar Access Globally

Samsung Bioepis Reports MHLW Approval of its Ustekinumab Biosimilar

Cipla Partners with Qilu Pharmaceutical to Commercialize QL2107 (Biosimilar, Keytruda) in the US

Alvotech Reports US FDA BLA Acceptance for AVT80 (Biosimilar, Entyvio)

Celltrion Reports Launch of Omlyclo 300mg (Biosimilar, Xolair) in Europe

Alvotech and Lotus Partner to Commercialize AVT34 (Biosimilar, Imfinzi) and AVT87 (Biosimilar, Hemlibra) Across the US and 8 Asian Countries

Henlius and Sandoz Partner on Up to 10 Biosimilar mAbs and ADC Products

Biocon Launches Yesafili (Biosimilar, Eylea) in the US

Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)

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