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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…
June 5, 2026

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INSIGHTS+

Key Biosimilars Events of May 2026 

Shots:  May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.  Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.  Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…
June 2, 2026

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INSIGHTS+

Key Biosimilars Events of April 2026 

Shots:  Regulatory momentum stayed strong in April 2026, with key approvals including Poherdy (EC), Tuyory (EC), and multiple denosumab biosimilars in Canada, alongside NMPA IND clearances for Henlius’ HLX319 and HLX05-N and Mabwell’s Maiweijian sBLA acceptance.  Strategic activity expanded globally through Mochida–Qilu and Mabwell partnerships, while major M&A deals, Amneal–Kashiv and Sun Pharma–Organon, signaled growing biosimilar consolidation.  Pipelines and commercialization progressed with CuraTeQ’s P-III success for BP11 and Biocon’s US launch of Bosaya and Aukelso,…
May 5, 2026

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INSIGHTS+

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,…
March 3, 2026

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NEWS

Saya Biologics and Kashiv BioSciences Partner to Introduce a Biosimilar Supportive Oncology Therapy in Mexico and the CAC Region 

Shots:  Saya Biologics has signed a strategic partnership with Kashiv BioSciences to register and commercialize a supportive oncology therapy in Mexico and the CAC region  As per the deal, the agreement spans 11 countries across Mexico and the CAC region. Saya Biologics will handle regulatory registration, commercialization, and distribution, while Kashiv BioSciences will oversee manufacturing and supply.   Saya has already submitted the regulatory dossier in Mexico,…
February 4, 2026

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NEWS

Kashiv Biosciences submits a BLA to the US FDA and receives EMA MAA acceptance for ADL-018 (Biosimilar, Xolair) 

Shots:  Kashiv BioSciences submitted a BLA to the US FDA and received EMA MAA acceptance for ADL-018, a proposed biosimilar to Xolair (omalizumab)  ADL-018 is a humanized mAb biosimilar to Xolair (omalizumab), designed to block IgE binding on mast cells and basophils. Xolair is approved for CSU (≥12 yrs), moderate-to-severe asthma (≥6 yrs), chronic rhinosinusitis…
October 6, 2025

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NEWS

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Shots: The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval Xolair is…
September 29, 2025

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NEWS

Kashiv BioSciences and JAMP Pharma Launch Pexegra (Biosimilar, Neulasta) and Filra (Biosimilar, Neupogen) in Canada

Shots: Kashiv BioSciences & JAMP Pharma have launched Pexegra & Filra, biosimilar version of Neulasta & Neupogen, respectively, in Canada JAMP Pharma & Kashiv BioSciences entered an exclusive agreement to market Pexegra & Filra in Canada, with Kashiv’s facilities supporting JAMP’s commercialization efforts Pexegra (6mg/0.6mL) & Filra (300mcg/0.5mL & 480mcg/0.8mL) help treat CT-induced neutropenia by…
September 25, 2025

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