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Pfizer, Merck and Astellas Report P-III (KEYNOTE-B15) Trial Findings on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-B15/EV-304) trial assessed Keytruda + Padcev (IV), followed by surgery & then Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts Trial showed 47% reduction in the risk of tumor recurrence, progression, or death, with an estimated 79.4% pts event-free at 2yrs. vs 66.2% with SoC, plus the combination…
March 2, 2026

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Merck Presents P-III (LITESPARK-022) Trial Data on Keytruda + Welireg in Clear Cell Renal Cell Carcinoma (RCC) at ASCO GU 2026

Shots: Merck has reported the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 1yr. in 1,841 pts with clear cell RCC following nephrectomy At 28.4mos. mFU, the trial showed improved DFS (1EP), reducing the risk of disease recurrence or death by 28%, with mDFS…
March 2, 2026

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NEWS

Formycon and Zydus Lifescience Report Successful Clinical Development of FYB206 (Biosimilar, Keytruda) 

Shots:  Formycon & Zydus Lifescience has reported that the pivotal Dahlia PK study of FYB206, a biosimilar version of Keytruda (pembrolizumab), has met its 1EP   The multicenter PK study showed bioequivalence of FYB206 (pembrolizumab) to Keytruda   Zydus Lifesciences has exclusively in-licensed FYB206, a proposed biosimilar to Keytruda (pembrolizumab), from Formycon for the US and Canada   Ref: Zydus Lifesciences | Image: Zydus Lifesciences and Formycon | Press Release  Related…
February 25, 2026

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Lotus Pharmaceutical Partners with Formycon to Commercialize FYB206 (Biosimilar, Keytruda) across APAC Region

Shots: Formycon & Lotus have reported the conclusion of their exclusive license agreement for Formycon’s FYB206, a biosimilar version of Keytruda (Pembrolizumab), in the APAC market Upon closing, Formycon will receive an upfront payment, plus potential development & regulatory milestone payments, & a share of gross profits after launch, while retaining responsibility for manufacturing &…
February 12, 2026

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Merck Receives the FDA Approval for Keytruda and Keytruda Qlex, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Shots: The US FDA has approved Keytruda/Keytruda Qlex + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapy Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W) with CT…
February 12, 2026

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NEWS

Bio-Thera Partners with Avalon Pharma to Commercialize BAT3306 (Biosimilar, Keytruda) in Saudi Arabia and MENA 

Shots:  Bio-Thera and Avalon Pharma have signed commercialization and licensing agreements for BAT3306, a biosimilar version of Keytruda (Pembrolizumab)  As per the deal, Bio-Thera will oversee development, manufacturing, and supply of BAT3306, while Avalon Pharma will handle regulatory approvals and commercialization across Saudi Arabia and the MENA region  BAT3306 is a humanized monoclonal antibody and immune checkpoint inhibitor…
February 3, 2026

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INSIGHTS+

Key Biosimilars Events of December 2025  

Shots:        Regulatory and launch momentum accelerated globally in late 2025, with multiple FDA approvals, CHMP positive opinions, and EU/US launches for biosimilars referencing blockbuster biologics such as Prolia/Xgeva, Lucentis, Eylea, Xolair, Stelara, Simponi, Neulasta, Humira, Opdivo, and Keytruda—broadening patient access across oncology, immunology, ophthalmology, bone health, and allergy indications  Leading biosimilar developers including Samsung Bioepis, Celltrion, Alvotech, Formycon,…
January 6, 2026

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Merck Reports P-III (KEYNOTE-B15) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-B15/EV-304) trial assessed 4 cycles of Keytruda (IV) + Padcev (IV), followed by surgery & then Keytruda (IV, 13 cycles) plus Padcev (IV, 5 cycles) vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts (n=808) Trial showed that perioperative combination of Keytruda + Padcev significantly improved EFS, OS & pCR rates vs…
December 18, 2025

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