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Key Biosimilars Events of August 2025  
Shots:        Biosimilars are developed to be highly similar of approved biologics in terms of safety, purity, and potency         Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients         Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea). Our…
IDEAYA Biosciences Partners with Servier to Develop and Commercialize Darovasertib for Uveal Melanoma (UM)
Shots: IDEAYA has entered an exclusive licensing agreement granting Servier global regulatory and commercial rights to darovasertib, while retaining all the US rights IDEAYA & Servier will co-develop darovasertib & share costs, with Servier leading regulatory & commercial efforts worldwide excl. the US, in exchange for $210M upfront, ~$100M on approval, ~$220M in commercial milestones,…
Polpharma Biologics Enters into Licensing Deals with MS Pharma for Multiple Biosimilar Candidates
Shots: Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) region As per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing,…
OMass Therapeutics Collaborates with Genentech to Develop and Commercialize Small Molecule for Inflammatory Bowel Disease
OMass has entered into an exclusive collaboration & license deal with Genentech to develop & commercialize its preclinical oral small molecule program for inflammatory bowel disease As per the deal, OMass will receive $20M upfront & over $400M in preclinical, development, commercial, & sales milestones, with tiered royalties based on net sales Collaboration leverages OMass’…
Novartis
Novartis Reports P-IV (V-DIFFERENCE) Trial Findings on Leqvio (Inclisiran) for Hypercholesterolemia
Shots: Novartis has reported P-IV (V-DIFFERENCE) trial results evaluating Leqvio (n=898) vs PBO (n=872), both added to personalized lipid-lowering therapy (LLT), in 1,770 hypercholesterolemia pts not at guideline-recommended LDL-C goals Trial showed 85% vs 31% achieved their guideline-recommended LDL-C target after 90 days of treatment, with benefits seen as early as day 30 (81% on…
Shawn Opatka from Honeywell in a Riveting Dialogue Exchange with PharmaShots
AI-Mediated Recalls: Shawn Opatka from Honeywell in a Riveting Dialogue Exchange with PharmaShots
Shots:  Product recalls in biopharma and MedTech incur an unanticipated drain on budget, costing the industry between $2.5B to $5B per year on average  Honeywell’s TrackWise Recall Management helps biopharma and MedTech companies plan and execute recall processes seamlessly, contributing to improved patient safety and faster response times  Shawn Opatka, Vice President & General Manager,…