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

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Fresenius Kabi & Dr Reddy’s Laboratories Reports the US FDA Approval of Rituximab (Biosimilar, Rituxan)

Shots: The US FDA has approved Rituximab, a biosimilar version of Rituxan developed by Dr. Reddy's Laboratories, supported by analytical, non-clinical, and clinical data demonstrating high similarity and no clinically meaningful differences from Rituxan, meeting US biosimilar requirements Rituximab is a mAb targeting CD20 on B cells, leading to B-cell depletion through immune-mediated mechanisms. It is approved in the US for…

ByRidhi RastogiAugust 3, 2026

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Fresenius Kabi Reports FDA and EMA Acceptance of PB016 (Biosimilar, Entyvio) for Review

Shots: The US FDA and EMA have accepted the BLA & MAA, respectively, for PB016, a biosimilar version of Entyvio (vedolizumab) lyophilized vial for IV administration BLA was supported by an extensive development program assessing PB016 vs Entyvio, to evaluate its similarity to the reference product, consistent with regulatory requirements for biosimilar approval PB016 is…

ByRidhi RastogiAugust 3, 2026

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Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Shots: Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab) Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults Yesintek was previously approved as…

ByRidhi RastogiJuly 30, 2026

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Accord BioPharma Reports Commercial Availability of Osvyrti and Jubereq (Biosimilars, Prolia & Xgeva) in the US

Shots: Accord BioPharma has reported the launch of Osvyrti & Jubereq, interchangeable biosimilars to Amgen’s Prolia & Xgeva (denosumab), in the US Osvyrti (60mg PFS) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer…

ByRidhi RastogiJuly 24, 2026

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)

Fresenius Kabi & Dr Reddy’s Laboratories Reports the US FDA Approval of Rituximab (Biosimilar, Rituxan)

Fresenius Kabi Reports FDA and EMA Acceptance of PB016 (Biosimilar, Entyvio) for Review

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Accord BioPharma Reports Commercial Availability of Osvyrti and Jubereq (Biosimilars, Prolia & Xgeva) in the US

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