1) FDA Approves Lunsumio VELO™ for Subcutaneous Use in Follicular Lymphoma
Date: 22 December 2025
What’s new: The U.S. FDA granted accelerated approval to Lunsumio VELO™ (mosunetuzumab) — a subcutaneous (SC) bispecific antibody — for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This SC formulation reduces treatment administration time to about one minute versus traditional intravenous infusions.
Why it matters: Shorter administration and outpatient dosing may broaden accessibility and convenience for patients with advanced FL.
Source: Roche press release via GlobeNewswire (FDA approval announcement). Roche
2) FDA Approves Interchangeable Ranibizumab Biosimilar “NUFYMCO®” for AMD & Related Diseases
Date: 18 December 2025
What’s new: The U.S. FDA has approved NUFYMCO®, an interchangeable biosimilar to Lucentis® (ranibizumab), for the treatment of neovascular (wet) age-related macular degeneration (AMD) and other retinal diseases including diabetic macular edema and retinopathy.
Partnership: Zydus Lifesciences and Bioeq AG entered a strategic licensing, supply & commercialization agreement for the U.S. launch of NUFYMCO®, expanding biosimilar access in ophthalmology.
Why it matters: First interchangeable Lucentis biosimilar approved in the U.S. will enhance affordability and access for retinal disease treatments.
Source: Bioeq / Zydus press release via PR Newswire; aggregated reporting. PR Newswire
3) EMA CHMP Positive Opinion on Gotenfia (Golimumab Biosimilar)
Date: 12 December 2025
What’s new: The EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorization for Gotenfia, a biosimilar of golimumab, for multiple inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Why it matters: This recommendation accelerates options for lower-cost biologic therapy across major autoimmune diseases in the EU.
Source: EPAR info reflecting CHMP opinion and timeline. Wikipedia
4) GSK’s Exdensur (depemokimab) Approved in the UK for Severe Asthma & CRSwNP
Date: 15 December 2025
What’s new: In the United Kingdom, Exdensur (depemokimab) — a long-acting anti-IL-5 monoclonal antibody — received regulatory approval for add-on maintenance therapy in severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP).
Why it matters: Offers an extended dosing, biologic option that may improve adherence and control for chronic upper and lower airway diseases.
Source: GSK press release covering UK approval. GSK
5) Industry & Regulatory Developments: FDA News Actions (Mid-Dec)
Date: 15–19 December 2025
Highlights:
• FDA granted two National Priority Vouchers supporting accelerated review of priority therapies.
• FDA advanced approaches to leverage real-world evidence in drug and device reviews, aligning regulatory decisions with broader data insights.
• Actions to improve recall effectiveness following investigations related to infant formula.
Why it matters: These regulatory actions emphasize FDA’s commitment to modernizing review processes, accelerating innovation, and strengthening product safety enforcement.
Source: FDA press announcements (Dec 15 & Dec 19, 2025). USFDA
Summary – Key Themes
Oncology innovation: Subcutaneous bispecific antibody approvals improve patient convenience.
Biosimilars: Interchangeable ranibizumab expands U.S. ophthalmology treatment access.
Autoimmune disease options: CHMP positive opinion on golimumab biosimilar in EU.
Severe asthma & CRSwNP treatment: UK approval of Exdensur broadens biologic therapy options.
Regulatory modernization: FDA actions reinforce priority pathways and real-world evidence use.
Frequently Asked Questions(FAQs)
1. Which major regulatory approvals were announced during 15–27 December 2025?
Key approvals this period included the FDA’s accelerated approval of Lunsumio VELO (mosunetuzumab) subcutaneous formulation for relapsed/refractory follicular lymphoma, and UK authorization of GSK’s Exdensur (depemokimab) for severe asthma and CRSwNP. The week also saw progress in biosimilars and ophthalmology therapeutics through FDA and EU-related developments.
2. Why is the subcutaneous formulation of Lunsumio VELO important for oncology treatment?
The SC formulation enables rapid one-minute administration, reducing infusion burden and potentially improving patient convenience, clinic throughput, and treatment accessibility, especially in outpatient oncology settings.
3. What is the significance of the interchangeable ranibizumab biosimilar approval?
The approval of NUFYMCO (ranibizumab-biosimilar) as an interchangeable alternative to Lucentis is expected to lower treatment costs, expand payer adoption, and support broader access to retinal disease therapy in the U.S. market.
4. How does the EMA/CHMP opinion on the golimumab biosimilar impact European markets?
A positive CHMP opinion is a key step toward EU marketing authorization. Once approved, the biosimilar could increase competition across autoimmune indications, helping reduce biologic therapy expenditure for healthcare systems and payers.
5. What makes Exdensur (depemokimab) notable in asthma and CRSwNP care?
Exdensur is a long-acting anti-IL-5 monoclonal antibody designed for extended-interval dosing, which may improve treatment adherence and provide sustained control for patients with severe type-2 inflammation.
6. Were there any major policy or regulatory framework developments during this period?
Yes. Mid-December FDA communications highlighted initiatives around priority review vouchers, real-world evidence integration, and safety oversight enhancements, reflecting the agency’s continued push toward modernized and accelerated review pathways.
7. Who is this weekly pharma update most useful for?
This update is curated for global pharma buyers, distributors, CDMOs, portfolio strategists, regulatory teams, hospital procurement, and investment analysts who track drug approvals, launches, biosimilars, and partnership signals.
8. Can these updates be used for sourcing or market intelligence?
Yes — each item references authentic primary sources (FDA, EMA, company press releases). Teams may use the insights for pipeline tracking, supplier discovery, competitive benchmarking, and portfolio planning.
9. How often are these weekly pharma updates published?
They are typically published once per week, summarizing verified global developments across approvals, launches, trials, partnerships, and regulatory movements.
10. Where can readers find source links for verification?
Each news item in this edition includes a direct source citation (regulatory authority or official company release) so readers can validate and explore full announcements.
