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Samsung Bioepis
NEWS

Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan 

Shots:  Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation  Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026   It is also approved in Australia, Brazil, Canada,…
December 23, 2025

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NEWS

Actor Pharmaceuticals and Megalabs Collaborate with Formycon to commercialize FYB203 (Biosimilar, Eylea) in Australia and LATAM 

Shots:  Formycon has reported that Klinge Biopharma, holder of global rights to its FYB203 (biosimilar, Eylea), has granted exclusive commercialization rights to Actor Pharmaceuticals for Australia and to Megalabs for LATAM. Regulatory filing is submitted to Australia’s TGA, and Formycon is preparing approval applications with Megalabs for LATAM  As per the deal, Klinge will receive…
October 16, 2025

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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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VIEWPOINTS_Jason Hannon_2024
VIEWPOINTS

Funds Raised: Jason Hannon from Mainstay Medical in a Stimulating Conversation with PharmaShots

Shots:  Mainstay Medical recently raised $125M in the company’s largest funding round. The financing is intended to accelerate the commercial growth of the company’s ReActiv8, a restorative Neurostimulation therapy in the US, Europe, and Australia  Today, at PharmaShots, we had Jason Hannon, CEO of Mainstay Medical, who talked in great length about the ReActiv8 Restorative Neuromodulation System developed for…
May 27, 2024

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