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Samsung Bioepis Inks Settlement and Licensing Deal with Regeneron and Bayer for Commercialization of SB15 (Biosimilar, Eylea) 

Shots:  Samsung Bioepis has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of SB15, a biosimilar version of Eylea 2 mg (aflibercept 40 mg/mL solution), in markets excluding the US and Canada   The agreement allows Samsung Bioepis to launch SB15 in the UK from Jan 2026, across the EU from Apr 2026,…

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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,…

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Samsung Bioepis

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,…

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Averoa Receives the MHRA’s Approval for Xoanacyl to Treat Chronic Kidney Disease (CKD)

Shots: The UK’s MHRA has approved Xoanacyl (ferric citrate complex) for the treatment of concomitant elevated serum phosphorus & iron deficiency in CKD adults via International Recognition Procedure (Route B), following EC’s approval in Jun 2025 In Dec 2022, Averoa obtained an exclusive license from Akebia Therapeutics to develop & commercialize Xoanacyl in the EEA,…

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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…

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Viewpoints_Raphaël Ortiz

Enhancing Diagnostic Capabilities in Prostate Cancer: Raphaël Ortiz from Telix Pharmaceuticals in a Riveting Conversation with PharmaShots

Shots:  Telix Pharmaceuticals’ Illuccix is approved in the UK for detecting and localizing prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, using PET imaging.  Amidst a shortage of PET imaging agents in the UK and mainland Europe, Telix Pharmaceuticals has secured a significant advantage through an exclusive distribution partnership with Xiel Limited  Raphaël…

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Alvotech, Kashiv Biosciences & Advanz Pharma

Alvotech, Kashiv Biosciences and Advanz Pharma Report the MHRA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Shots: The UK’s MHRA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab) for the treatment of severe persistent allergic asthma & CRSwNP Alvotech & Advanz Pharma entered into a commercialization agreement for AVT23 in Feb 2023, expanding their alliance in May to incl. 5 more biosimilars, whereas in Oct 2023, Alvotech &…

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