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NEWS

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,…
January 29, 2026

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INSIGHTS+

2025 EMA Drug Approvals Outlook: A Year of Intentional, Biology Led Medicine Across Europe 

Shots:  EMA approvals in 2025 reinforce a biology-first regulatory standard, favoring mutation-exact, genotype-defined, and severity-weighted therapies that narrow indications, elevate rare diseases, and reward durability of benefit over rapid market expansion  Convenience at the EMA is no longer cosmetic, it is integral to benefit–risk assessment, with oral, subcutaneous, and low-burden dosing strategies increasingly tied to adherence, long-term outcomes,…
January 22, 2026

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NEWS

Gan & Lee Pharmaceuticals Gains the CHMP’s Positive Opinion for Ondibta (Biosimilar, Lantus SoloStar) 

Shots:  The CHMP has recommended Ondibta, a biosimilar insulin glargine pre-filled pen for pts (age≥ 2), reference medicine Lantus SoloStar. The EC will now review the opinion, and approval is anticipated across the EU and EEA states   Insulin glargine is a long-acting, once-daily basal insulin analog that provides up to 24 hours of steady, peakless glucose-lowering activity   Ondibta completed head-to-head P-III trials in both the EU and the US against Lantus, with studies in…
November 13, 2025

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NEWS

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,…
November 6, 2025

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INSIGHTS+

New Drug Designations – September 2025    

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA   The September 2025 report covers designations granted to 33 drugs and 4 medical devices, spanning 12 small molecules, 6 biologics, 8 cell and gene therapies & 4 medical devices among others  …
October 28, 2025

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NEWS

AstraZeneca and Amgen’s Tezspire (Tezepelumab) Secures the EU Approval for Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The EU approved Tezspire as an add-on treatment with intranasal corticosteroids for adults with severe CRSwNP unresponsive to standard therapies; regulatory review is ongoing in China, Japan, and several other countries Approval was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by…
October 23, 2025

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NEWS

GSK’s Shingrix PFS Presentation Receives the CHMP’s Positive Opinion

Shots: The CHMP has recommended Shingrix in a PFS (Recombinant Zoster Vaccine or RZV), simplifying administration by eliminating vial reconstitution for the prevention of shingles (herpes zoster). EU marketing authorization is expected in December 2025 The opinion was based on data showing that the PFS matches the existing vaccine Shingrix combines glycoprotein E antigen with…
October 23, 2025

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NEWS

Teva and Prestige Biopharma Sign a Licensing Agreement to Commercialize Tuznue (Biosimilar, Herceptin) Across EU

Shots: Teva Pharmaceuticals and Prestige Biopharma have signed a license and supply agreement to commercialize Tuznue (trastuzumab), a Herceptin biosimilar, in most European markets As per the deal, Teva will market and distribute Tuznue in most European markets, while Prestige Biopharma will handle production and supply from its EU-GMP-certified facilities Tuznue, biosimilar of Herceptin, with…
October 21, 2025

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INSIGHTS+

New Drug Designations – August 2025     

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA    The August 2025 report covers designations granted to 37 drugs and 4 medical devices, spanning 14 small molecules, 5 biologics, 7 cell and gene therapies & 4 medical devices, among others    Significant…
September 23, 2025

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CuraTeQ
NEWS

CuraTeQ Biologics Reports Positive P-III study results for Denosumab biosimilar for postmenopausal osteoporosis 

Shots:  CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported positive P-III results for its denosumab biosimilar targeting postmenopausal osteoporosis, as an alternative to Prolia  The study involved 446 postmenopausal women across 40 sites in EU met all EPs, showing no significant differences between the biosimilar and Prolia  The trial confirmed the biosimilar's efficacy in improving…
September 19, 2025

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