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Amgen Escalates Patent Defense with Three New Biosimilar Lawsuits Targeting Denosumab Competitors

Monoclonal AntibodyFDA Approval
  • Amgen filed three separate BPCIA patent infringement lawsuits in late June 2025 against companies developing denosumab biosimilars, including Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon.
  • The lawsuits allege infringement of 26-34 patents each and claim the defendants failed to comply with BPCIA "patent dance" requirements by withholding key manufacturing information.
  • These cases represent the sixth, seventh, and eighth denosumab biosimilar litigations by Amgen, following previous suits against Sandoz, Celltrion, Samsung Bioepis, Fresenius, and Accord Biopharma.
  • The targeted biosimilars include RGB-14-P/RGB-14-X (Hikma/Richter), HLX14 (Shanghai Henlius/Organon), and an unnamed Biocon product, all seeking to compete with Amgen's Prolia and Xgeva brands.

Astellas Commits €129 Million to Expand Irish Operations with Focus on Biologics Manufacturing

Monoclonal Antibody
  • Astellas, one of Japan's largest life sciences companies, announced a €129 million investment in its Irish operations over the next three years, focusing on development, sustainability, and research initiatives.
  • The investment will support the company's €330 million Tralee facility currently under construction, which is expected to create 350 additional jobs and become fully operational by 2028.
  • The expansion includes establishing research and development capabilities for antibody-drug conjugates and monoclonal antibodies, aiming to create a high-efficiency, multi-product biologics facility.
  • Green initiatives represent a significant component of the investment, with plans for wind turbines, solar panels, and energy-efficient systems to reduce CO₂ emissions across both Kerry facilities.

Teva Partners with Formycon to Commercialize Stelara Biosimilar Fymskina in Germany

Monoclonal AntibodyDrug Approval
  • Formycon AG has entered into a distribution agreement with Teva's subsidiary Ratiopharm for the semi-exclusive commercialization of its Stelara biosimilar FYB202, branded as Fymskina, in Germany.
  • The market launch for Fymskina is scheduled for the third quarter of 2025, with Formycon handling manufacturing and supply while Ratiopharm manages commercialization.
  • Fymskina has already received European Commission approval for treating moderate to severely active Crohn's disease, moderate to severe plaque psoriasis, and active psoriatic arthritis.
  • This partnership represents Formycon's strategic approach to expand market coverage through semi-exclusive partnerships, building on its existing global commercialization agreement with Fresenius Kabi.

Percheron Therapeutics Acquires Phase II-Ready Anti-VISTA Cancer Immunotherapy HMBD-002 in $290M Deal

Monoclonal Antibody
  • Percheron Therapeutics has licensed HMBD-002, a first-in-class monoclonal antibody targeting the VISTA immune checkpoint, from Hummingbird Bioscience in a deal worth up to $290 million.
  • The drug has successfully completed Phase I trials showing it is pharmacologically active, safe and well-tolerated, with Percheron planning to initiate Phase II trials in 2026.
  • HMBD-002 targets VISTA, a novel checkpoint protein that could reinvigorate immune responses in cancers resistant to existing checkpoint inhibitors like PD-1 or CTLA-4.
  • The licensing agreement marks a strategic shift for Percheron from rare diseases to immuno-oncology, following disappointing results with its previous asset avicursen.

CDC's Reconstituted Vaccine Advisory Panel Votes to Eliminate Thimerosal from All Flu Vaccines

Monoclonal Antibody
  • The newly appointed Advisory Committee on Immunization Practices (ACIP) voted 5-1 to recommend thimerosal-free influenza vaccines for all age groups, despite the preservative being present in only 6% of U.S. flu vaccines.
  • Committee members expressed concerns that restricting thimerosal-containing vaccines could reduce vaccine access, particularly in global markets where multi-dose vials are more cost-effective.
  • The panel also approved RSV prevention recommendations, voting 5-2 to recommend clesrovimab for infants under 8 months during their first RSV season.
  • Public health experts criticized the committee's focus on thimerosal as scientifically unfounded, noting the preservative was already removed from pediatric vaccines over 20 years ago.

Vetigenics Initiates First Dual Immune Checkpoint Inhibitor Trial in Dogs with Solid Tumors

Monoclonal Antibody
  • Vetigenics has dosed the first patient in its CHECKMATE K9 pilot study at the University of Wisconsin, combining anti-cCTLA-4 and anti-cPD-1 monoclonal antibodies in dogs with solid tumors.
  • The open-label multisite study involves seven leading veterinary oncology investigators across academic centers and aims to assess safety and preliminary efficacy signals.
  • This marks a major advancement in veterinary oncology and represents the first dual immune checkpoint inhibitor study in canine cancer treatment.
  • The research builds on landmark dual immune checkpoint inhibitor studies in human cancer and aims to strengthen the bridge between animal and human cancer research.

Q32 Bio Names Adrien Sipos as Interim CMO to Lead Alopecia Areata Drug Development

Monoclonal AntibodyLeadership Change
  • Q32 Bio appointed Adrien Sipos, M.D., Ph.D., as Interim Chief Medical Officer to oversee the ongoing SIGNAL-AA Phase 2a clinical trial of bempikibart for alopecia areata treatment.
  • Dr. Sipos brings over 25 years of immunology and inflammation drug development experience from leadership roles at Biogen, Sanofi Genzyme, and Eli Lilly.
  • The company expects topline results from Part B of the SIGNAL-AA Phase 2a trial in the first half of 2026 for their novel anti-IL-7Rα antibody therapy.
  • Bempikibart represents a novel therapeutic approach targeting IL-7 and TSLP signaling pathways to treat alopecia areata, which affects approximately 700,000 Americans.

Galderma Launches Phase II Trials of Nemolizumab for Systemic Sclerosis and Chronic Pruritus of Unknown Origin

Monoclonal AntibodyRare Disease
  • Galderma has initiated two phase II clinical trials investigating nemolizumab, an IL-31 receptor alpha-targeting monoclonal antibody, for treating systemic sclerosis and chronic pruritus of unknown origin.
  • The systemic sclerosis trial will be a multicenter, randomized, double-blind, placebo-controlled study beginning enrollment in H2 2025 with completion anticipated in 2028.
  • The chronic pruritus of unknown origin trial will explore nemolizumab's efficacy in treating persistent itch lasting more than six weeks without identified cause, with enrollment starting in H2 2025 in the U.S.
  • Both conditions represent significant unmet medical needs, with systemic sclerosis being a potentially fatal autoimmune disease and chronic pruritus of unknown origin having no currently approved treatments.

Guselkumab Demonstrates High Efficacy for Psoriasis Treatment Across All Skin Tones in Landmark VISIBLE Trial

Monoclonal Antibody
  • The VISIBLE trial represents the first prospective randomized clinical trial evaluating psoriasis treatment across the complete spectrum of objectively measured skin tones, addressing critical gaps in dermatology research for underrepresented populations.
  • Guselkumab achieved remarkable efficacy rates with approximately 70% of participants reaching clear or almost clear skin and over 50% achieving complete skin clearance by week 48, with mean improvements exceeding 94% in both body and scalp psoriasis measures.
  • The study successfully enrolled and retained over 90% of participants with skin of color through innovative trial design features, demonstrating that diverse clinical trial participation is achievable in dermatology research.
  • Safety profiles remained consistent with established guselkumab data, with infections being the most common adverse events and no serious safety signals identified across the diverse patient population.

Biocon Biologics Partners with Malaysia's National Cancer Society to Launch Biosimilar Access Program

OncologyMonoclonal Antibody
  • Biocon Biologics has partnered with the National Cancer Society of Malaysia to launch a Patient Assistance Programme providing affordable oncology biosimilars to underserved cancer patients.
  • The program will initially focus on providing trastuzumab to patients facing treatment delays due to financial constraints, with plans to expand to pegfilgrastim and bevacizumab.
  • This collaboration builds on Biocon's previous success in Malaysia's diabetes care, where the company has served over 345,000 patients through affordable treatment programs.
  • The partnership combines Biocon's biosimilar expertise with NCSM's community outreach capabilities to enhance cancer care accessibility in Malaysia.

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