Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Shots: The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev. active ulcerative colitis & Crohn’s disease BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity between AVT16 & the reference product, plus Alvotech has filed a…

ByRidhi Rastogi4 days ago

NEWS

Health Canada Accepts the MAA for Kashiv BioSciences’ ADL-018 (Biosimilar, Xolair)

Shots: Kashiv BioSciences has reported that Health Canada has validated and accepted the MAA for ADL-018, a biosimilar version of Xolair (omalizumab) Omalizumab is approved for multiple allergic & inflammatory conditions, incl. mod. to sev. persistent asthma (≥6yrs.), CRSwNP (≥18yrs.), chronic spontaneous urticaria (≥12 yrs.), & IgE-mediated food allergy (>1yr.) Additionally, Alvotech & Kashiv BioSciences have…

ByRidhi RastogiJune 5, 2026

NEWS

Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

Shots: The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept) Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems…

ByRidhi RastogiJune 4, 2026

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Key Biosimilars Events of February 2026

Shots: Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars. Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…

ByDipanshu DixitMarch 3, 2026

NEWS

Alvotech Reveals PK Data on AVT80 (Biosimilar, Entyvio)

Shots: Alvotech reported positive top-line data from the AVT80-GL-P01 PK study comparing AVT80 with Entyvio in healthy adults The study met all 1EP, demonstrating PK similarity between AVT80 & Entyvio following a single 108mg/0.68mL SC dose, supporting AVT80’s biosimilar profile Alvotech is developing AVT16 (IV) & AVT80 (SC) as Entyvio’s biosimilars, with the AVT80-GL-P01 study…

ByRidhi RastogiFebruary 5, 2026

NEWS

Alvotech and Sandoz Partner to Expand Access to Biosimilars Across Canada, Australia, & New Zealand

Shots: Alvotech has entered into supply & commercialization agreements with Sandoz for multiple biosimilar candidates across Canada, Australia, & New Zealand In Canada, the deal includes one ophthalmology biosimilar in a prefilled intravitreal syringe, while in Australia & New Zealand, it covers 3 biosimilar candidates across immunology & gastroenterology in multiple formulations As per the…

ByRidhi RastogiFebruary 2, 2026

NEWS

Alvotech Inks Settlement and Licensing Deal with Regeneron and Bayer for Worldwide Commercialization for its Biosimilar to Eylea

Shots: Alvotech has signed a settlement and license agreement with Regeneron and Bayer for Eylea 2 mg (aflibercept) biosimilar. With prior US rights effective Q4’26, Alvotech now holds worldwide manufacturing and supply rights for its commercial partners The settlement enables Alvotech and partners to launch the biosimilar from Jan 1, 2026, in the UK and Canada, May 1, 2026,…

ByDipanshu DixitJanuary 29, 2026

INSIGHTS+

Key Biosimilars Events of December 2025

Shots: Regulatory and launch momentum accelerated globally in late 2025, with multiple FDA approvals, CHMP positive opinions, and EU/US launches for biosimilars referencing blockbuster biologics such as Prolia/Xgeva, Lucentis, Eylea, Xolair, Stelara, Simponi, Neulasta, Humira, Opdivo, and Keytruda—broadening patient access across oncology, immunology, ophthalmology, bone health, and allergy indications Leading biosimilar developers including Samsung Bioepis, Celltrion, Alvotech, Formycon,…

ByDipanshu DixitJanuary 6, 2026

NEWS

Alvotech Reports the European Launch of Gobivaz (Biosimilar, Simponi)

Shots: Alvotech has reported the launch of Gobivaz (AVT05), a biosimilar version of Simponi (golimumab) for the treatment of several chronic inflammatory diseases, with commercialization led by Advanz Pharma In the UK, Gobivaz’s launch is supported by an NHS England tender award, while rollout across EEA markets will advance in line with country-specific pricing, reimbursement…

ByRidhi RastogiDecember 23, 2025

NEWS

Alvotech and Teva Enter into an Agreement with Regeneron to Launch AVT06 (Biosimilar, Eylea) Across US

Shots: Alvotech and Teva reached a settlement and license agreement with Regeneron, allowing the US launch of AVT06, a biosimilar version of Eylea (aflibercept) in Q4’26 or earlier under certain conditions AVT06 is an aflibercept (Eylea) biosimilar that inhibits VEGF and has been approved as Mynzepli in the UK and EEA and as Aflibercept BS in Japan On…

ByDipanshu DixitDecember 19, 2025

Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Health Canada Accepts the MAA for Kashiv BioSciences’ ADL-018 (Biosimilar, Xolair)

Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

Key Biosimilars Events of February 2026

Alvotech Reveals PK Data on AVT80 (Biosimilar, Entyvio)

Alvotech and Sandoz Partner to Expand Access to Biosimilars Across Canada, Australia, & New Zealand

Alvotech Inks Settlement and Licensing Deal with Regeneron and Bayer for Worldwide Commercialization for its Biosimilar to Eylea

Key Biosimilars Events of December 2025

Alvotech Reports the European Launch of Gobivaz (Biosimilar, Simponi)

Alvotech and Teva Enter into an Agreement with Regeneron to Launch AVT06 (Biosimilar, Eylea) Across US

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