GlycoNex Reports the P-III Trial Data on SPD8 (Biosimilar, Denosumab)

Shots: GlycoNex has reported the P-III trial results assessing SPD8 (SC, Q6M), a biosimilar version of denosumab co-developed with Mitsubishi Gas Chemical, vs Prolia in 266 Japanese subjects with osteoporosis Trial met its 1EP, with SPD8 demonstrating therapeutic equivalence to Prolia. The between-group difference in the 1EP & its 95% confidence interval fell within the pre-specified…

ByRidhi Rastogi2 days ago

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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

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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

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Teva Launches Ahzantive (Biosimilar, Eylea) Across Key EU Markets

Shots: Teva has launched Ahzantive, a biosimilar version of Eylea, in EU, with pre-filled syringe launches beginning in May 2026 in France, Germany, Spain, & the Netherlands, and additional market launches planned later in 2026 Ahzantive received EC approval in 2025 for the treatment of wet age-related macular degeneration, diabetic macular edema, visual impairment due…

ByRidhi RastogiJune 5, 2026

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Xbrane Reports the US FDA Acceptance of Resubmitted BLA for Lucamzi (Biosimilar, Lucentis)

Shots: The US FDA has accepted the resubmitted BLA for Xbrane's Lucamzi, a biosimilar to Lucentis, & assigned a BsUFA action date of Oct 29, 2026 The resubmission, completed in Apr 2026, addressed issues identified in the CRL received from the FDA in Oct 2025 The product is already approved & marketed in EU as…

ByRidhi RastogiJune 4, 2026

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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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Samsung Bioepis Reports the EC Launch of Opuviz (Biosimilar, Eylea)

Shots: Samsung Bioepis to directly commercialize Opuviz 40 mg/mL solution for injection in a vial, a biosimilar version of Eylea (aflibercept), across the EU Opuviz is indicated to treat wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), diabetic macular oedema (DME), and…

ByRidhi RastogiMay 29, 2026

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Polpharma Partners with Tuteur to Commercialize a Biosimilar Candidate Across LATAM for Autoimmune Diseases

Shots: Polpharma Biologics has entered into a licensing agreement with Tuteur to commercialize a biosimilar candidate for autoimmune diseases across Latin America, excl. Brazil As per the deal, Tuteur will handle commercialization, marketing, & distribution in the licensed territories, while Polpharma will be responsible for the development & manufacturing of the biosimilar candidate The biosimilar…

ByRidhi RastogiMay 22, 2026

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Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

Shots: Samsung Bioepis has reported the launch of Ustekinumab BS 45 mg Syringe for SC Injection 「NIPRO」, a biosimilar version of Stelara, in Japan, marking the company’s first commercialized product in the country The biosimilar will be commercialized by NIPRO CORPORATION under a strategic partnership between Samsung Bioepis & NIPRO in 2025, focused on developing &…

ByRidhi RastogiMay 20, 2026

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Formycon and Klinge Biopharma Launch FYB203 (Biosimilar, Eylea) in the EU

Shots: Formycon and licensing partner Klinge Biopharma have reported the EU launch of FYB203, a biosimilar version of Eylea 2mg (aflibercept) FYB203 is now available in the EU as a PFS under the brand names Ahzantive and Baiama. The launch began on May 15, 2026, in key markets including Germany, France, and Italy, with further expansion across Central and Eastern Europe planned…

ByDipanshu DixitMay 19, 2026

GlycoNex Reports the P-III Trial Data on SPD8 (Biosimilar, Denosumab)

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

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

Teva Launches Ahzantive (Biosimilar, Eylea) Across Key EU Markets

Xbrane Reports the US FDA Acceptance of Resubmitted BLA for Lucamzi (Biosimilar, Lucentis)

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

Samsung Bioepis Reports the EC Launch of Opuviz (Biosimilar, Eylea)

Polpharma Partners with Tuteur to Commercialize a Biosimilar Candidate Across LATAM for Autoimmune Diseases

Samsung Bioepis Introduces its Ustekinumab Biosimilar in Japan with NIPRO CORPORATION

Formycon and Klinge Biopharma Launch FYB203 (Biosimilar, Eylea) in the EU

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