GSK Portfolio Dossier: ViiV HIV, Nucala Runway, and Oncology Rebuild

The commercial strategy of GSK plc in 2026 reflects a focused biopharmaceutical entity entering a new era of executive leadership. Following the spinoff of its consumer healthcare business Haleon in 2022, GSK consolidated its operations around vaccines, specialty medicines, and general medicines. With the transition to new CEO Luke Miels (effective January 1, 2026, succeeding Emma Walmsley who remains on board through September 30, 2026 to support the transition), the market is closely analyzing the company’s ability to meet its stated long-term ambition of delivering over £40 billion in annual sales by 2031.

This ambition relies heavily on the performance of GSK's primary business units: the ViiV Healthcare HIV joint venture, which is leading a market transition toward long-acting injectables; the respiratory biologics franchise, anchored by Nucala (mepolizumab) and the recently approved ultra-long-acting IL-5 inhibitor depemokimab; a vaccine portfolio spearheaded by Shingrix and Arexvy; and a rebuilt oncology franchise. By analyzing GSK's FY2025 financial disclosures, the latest FDA Orange Book and Purple Book registries, and CMS retail drug acquisition cost (NADAC) data, this portfolio dossier maps the commercial moats, biosimilar cliffs, and clinical-access mechanics that define GSK’s position.

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Quick Answer

What is the scenario question? If a P&T or market-access team needs to understand GSK's 2026 portfolio—ViiV HIV, respiratory Ellipta, vaccines, oncology, the CEO transition, and Nucala's biosimilar runway—what does the primary evidence show?

Direct Answer: GSK enters 2026 following a strong fiscal year, reporting £32.667 billion in FY2025 turnover (+7% at constant exchange rates, CER) and core EPS of 172.0p (+12% CER). The growth engine is the Specialty Medicines segment (£13.474 billion, +17% CER), led by ViiV Healthcare's HIV franchise, which generated £7.687 billion (+11% CER) as payers transitioned from daily oral regimens to long-acting injectables (Cabenuva and Apretude). In the respiratory sector, GSK has built a durable runway: Nucala (mepolizumab) has no approved U.S. biosimilar, with its nearest competitor, Bio-Thera’s BAT2606, in clinical trials only. This runway is bolstered by the FDA approval of the once-every-6-months IL-5 biologic depemokimab (Exdensur) in December 2025. In vaccines, Shingrix remains a major block (£3.558 billion), while the RSV vaccine Arexvy posted £593 million amid tightening market competition. GSK's oncology business (£1.977 billion, +43% CER) is rebuilding around the PD-1 inhibitor Jemperli (dostarlimab) and the re-approval of the BCMA-targeting antibody-drug conjugate Blenrep (belantamab mafodotin). In the respiratory small-molecule channel, mature Ellipta products (Breo, Trelegy) face erosion, with Breo’s latest patents expiring in September 2030 (exclusivity ending November 2026) and 4 generic ANDA applicants competing in the fluticasone/salmeterol market.

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Who this is for

• Payer Account Managers and PBM Formulary Directors: Modeling multi-year rebate structures for ViiV HIV oral regimens vs. long-acting injectables, and negotiating specialty tier placement for respiratory biologics.
• Biopharma Business Development and Equity Analysts: Assessing the return on investment of the Cerevel and Nuvalent BD transactions, evaluating the commercial impact of the Luke Miels transition, and forecasting Arexvy vs. Abrysvo market share.
• Specialty Pharmacists and Clinic Directors: Reviewing clinical substitution guidelines for asthma biologics, injection-interval workflows for Cabenuva, and safety protocols for BCMA-ADC administration.
• Regulatory and Intellectual Property Counsel: Monitoring Orange Book patent certifications for Ellipta inhalers and ViiV small-molecule NDAs, Paragraph IV challenges, and Purple Book biosimilar filing timelines.

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Methodology

Corporate financial performance, turnover statistics, and product-specific revenues are compiled from GSK plc's Q4/FY2025 and Q1 2026 results announcements, annual reports, and investor relations disclosures. Patent expiries, exclusivity codes, and abbreviated new drug application (ANDA) generic counts are computed from the July 8, 2026 snapshot of the FDA Orange Book database. Biological licensing numbers, reference product exclusivity dates, and orphan drug designations are retrieved from the FDA Purple Book. National drug pricing trends and pharmacy acquisition costs are extracted from the CMS National Average Drug Acquisition Cost (NADAC) database. All financial values are reported in British Pounds (GBP) or U.S. Dollars (USD) as disclosed in the primary sources.

For comparative analyses of peer portfolios, see the AstraZeneca portfolio dossier; for biosimilar cliff transitions, see the J&J/Janssen portfolio dossier; and for BD pipeline acquisitions, see the GSK-Nuvalent lung-cancer deal analysis.

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How big is GSK's FY2025 portfolio across Specialty, Vaccines, and General Medicines?

GSK delivered strong financial performance in its first full years as a pure-play biopharma company, reporting turnover of £32.667 billion in FY2025, representing a 4% increase on an Actual Exchange Rate (AER) basis and 7% at Constant Exchange Rates (CER). Core operating profit reached £9.783 billion (+11% CER), reflecting expanded operating margins due to the high-margin specialty mix, while core EPS grew 12% CER to 172.0p. GSK’s long-term commercial trajectory is supported by a $30 billion five-year U.S. investment plan focused on expanding clinical development sites, biomanufacturing facilities, and commercial hubs.

The portfolio is structured across three distinct segments:

• Specialty Medicines: Generating £13.474 billion (+17% CER) in FY2025, representing 41.2% of total group turnover. The specialty engine is driven by ViiV Healthcare (GSK's joint venture with Shionogi and Pfizer), which posted HIV sales of £7.687 billion (+11% CER). Specialty respiratory and immunology/inflammation (RI&I) contributed £3.810 billion (+18% CER), led by the biologic Benlysta (belimumab) for lupus and Nucala (mepolizumab) for eosinophilic diseases. Oncology added £1.977 billion (+43% CER), reflecting a rapid rebuilding phase.
• Vaccines: Posting sales of £9.157 billion (+2% CER). The segment is anchored by the shingles vaccine Shingrix, which generated £3.558 billion (+8% CER), demonstrating continued global expansion, particularly in Europe (+20% in Q1 2026) and ongoing launches in international markets. The RSV vaccine Arexvy contributed £593 million (+2% CER), showing stable baseline performance but facing intense head-to-head competitive contracting from Pfizer’s Abrysvo in the commercial retail channel, which has compressed net margins. Meningitis vaccines added £1.583 billion (+12% CER), driven by the pediatric and adolescent uptake of Bexsero (Meningococcal Group B Vaccine) and Menveo.
• General Medicines: Contributing £10.036 billion (-1% CER), showing a flat-to-declining profile as mature products face generic competition. However, the triple-therapy respiratory inhaler Trelegy Ellipta remains a major blockbuster, posting turnover of £3.011 billion (+13% CER), which offset declines in older inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) products.

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What is ViiV's HIV strategy in 2026 — Dovato, Cabenuva, and long-acting competition?

ViiV Healthcare’s commercial strategy is designed to defend its market share against Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) by leading two transitions: two-drug regimens (2DRs) and long-acting injectables (LAIs).

• The Two-Drug Regimen (2DR) Moat: GSK has successfully positioned Dovato (dolutegravir/lamivudine) as a preferred, low-toxicity alternative to traditional three-drug regimens for treatment-naive and virologically suppressed patients. Dovato generated $899 million in U.S. sales in Q1 2026, representing a 24.7% YoY increase. Because dolutegravir (Tivicay) is protected by primary formulation patents and compound patents (NDA 204790) through October 5, 2027 (with pediatric extensions pushing selected exclusivities into 2028), Dovato remains a highly durable oral asset.
• The Long-Acting Injectable (LAI) Transition: The primary growth drivers in the HIV business are Cabenuva (cabotegravir/rilpivirine) for treatment and Apretude (cabotegravir) for pre-exposure prophylaxis (PrEP). Cabenuva, administered once monthly or once every two months, generated $497 million in Q1 2026 (+33.6% YoY). Cabenuva (cabotegravir/rilpivirine, NDA 212888) is protected by device and formulation patents (US Patents 11,224,597 and 12,138,264) extending to September 15, 2031, while the oral cabotegravir lead-in Vocabria (NDA 212887) carries patents to February 4, 2031 (US Patent 8,410,103). By transitioning patients from daily oral pills to multi-month injectables, ViiV secures long-term commercial loyalty and insulates its franchise from generic oral competition.
• Access Mechanics: PBMs gate long-acting injectables through the medical benefit, requiring clinical documentation of prior treatment adherence, suppressed viral load (<50 copies/mL), and no history of treatment failure or resistance to cabotegravir or rilpivirine. Apretude for PrEP has secured favorable commercial tiering due to federal mandates requiring zero-cost coverage for selected preventive services, though PBMs continue to negotiate rebate structures.

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How protected is Nucala (mepolizumab) from biosimilars, and what does depemokimab add?

While peer immunology and respiratory biologics (such as Roche’s Actemra or J&J’s Stelara) are managing active biosimilar competition in 2026, GSK’s mepolizumab (Nucala) franchise maintains a highly protected runway:

• The Biosimilar Runway: Mepolizumab is licensed under BLA 125526 (and BLA 761122 for the autoinjector). The FDA Purple Book shows that mepolizumab has no approved U.S. biosimilar. The closest competitor in development is Bio-Thera Solutions’ BAT2606, which remains in Phase III clinical trials (per Cardinal Health's pipeline tracker) and is not expected to enter the market until late 2027 or 2028 at the earliest. Mepolizumab also carries active orphan drug exclusivity for eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES) through September 25, 2027.
• COPD Label Expansion: Mepolizumab's runway was further extended by its FDA approval on May 22, 2025 as an add-on maintenance treatment for adult patients with severe chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, opening a massive new patient population prior to biosimilar exposure.
• Depemokimab (Exdensur) Transition: To secure its long-term respiratory franchise, GSK is transitioning patients from Nucala (administered once every 4 weeks) to depemokimab (Exdensur), which was approved by the FDA on December 16, 2025. Depemokimab is an ultra-long-acting IL-5 antagonist designed to have high target affinity and an extended half-life, allowing for dosing once every six months (two injections per year). By establishing patients on a twice-yearly dosing schedule, GSK creates a powerful clinical and commercial barrier that generic once-monthly mepolizumab biosimilars will find difficult to displace, securing its market share into the mid-2030s.

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What is GSK's oncology rebuild (Jemperli, Blenrep, Ojjaara, Zejula) under new CEO Luke Miels?

Under the leadership of new CEO Luke Miels, GSK is executing an aggressive oncology reboot, expanding the segment by 43% CER to £1.977 billion in FY2025. This rebuild is characterized by targeted business development and clinical lifecycle management:

• Jemperli's Expansion: Jemperli (dostarlimab, BLA 761174), an anti-PD-1 monoclonal antibody, has become a core growth driver. Approved for mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, Jemperli is actively challenging Merck’s Keytruda by moving into first-line endometrial indications. In the pivotal RUBY Phase III clinical trial, dostarlimab combined with standard chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS) in patients with primary advanced or recurrent endometrial cancer. This clinical success has driven a rapid rate of clinician adoption and formulary acceptance across major commercial insurers.
• The Blenrep Comeback: Blenrep (belantamab mafodotin, BLA 761440), a BCMA-targeting antibody-drug conjugate (ADC), was voluntarily withdrawn from the U.S. market in 2022 following the failure of the DREAMM-3 trial. However, following positive Phase III readouts from the DREAMM-7 and DREAMM-8 trials (demonstrating significant progression-free survival benefits when combined with standard regimens in relapsed/refractory multiple myeloma), the FDA re-approved Blenrep in late 2025. Specifically, the DREAMM-7 trial demonstrated that Blenrep in combination with bortezomib and dexamethasone (BorDex) reduced the risk of disease progression or death by 59% compared to a standard daratumumab combination, while the DREAMM-8 trial evaluated Blenrep combined with pomalidomide and dexamethasone (PomDex) against a standard elotuzumab combination, confirming its value in the second-line multiple myeloma space.
• Ojjaara and Zejula: Ojjaara (momelotinib, NDA 216873), a once-daily oral JAK1/JAK2 and ACVR1 inhibitor for myelofibrosis patients with anemia, is protected by Orange Book patents extending to June 11, 2035 (US Patent RE48285). The PARP inhibitor Zejula (niraparib, NDA 208447) contributed stable sales of $154 million in Q1 2026, supported by orphan drug exclusivity running through October 2026.
• Oncology Business Development: To sustain this momentum, Luke Miels oversaw the expansion of GSK's oncology pipeline, including the $1.1 billion Nuvalent deal in late 2025 to co-develop next-generation ROS1 and ALK inhibitors for non-small cell lung cancer, filling a critical gap in GSK’s solid-tumor pipeline. This strategic collaboration centers on NVL-520 (a highly selective ROS1 inhibitor) and NVL-655 (a selective ALK inhibitor), both designed to overcome treatment resistance mutations in patients with pre-treated non-small cell lung cancer (NSCLC). By adding these small-molecule kinase inhibitors to its pipeline, GSK positions itself to compete in the targeted solid tumor market, complementing its antibody-drug conjugate (ADC) and monoclonal antibody portfolio.

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What do Orange Book patents, NADAC, and Purple Book reveal about GSK's respiratory and HIV cliffs?

Integrating Orange Book patent listings, Purple Book biologics registries, and CMS drug acquisition cost data illustrates GSK's transition from small-molecule cliffs to biological moats.

Table 3: GSK Key Assets, Patents, and Acquisition Costs (FDA OB/PB & CMS NADAC)

Patent and Pricing Analysis:

• The Advair Generic Deflation: Advair (fluticasone propionate/salmeterol xinafoate) represents a fully genericized market. The FDA Orange Book lists 4 active ANDA applicants actively marketing generic fluticasone/salmeterol inhalers. CMS NADAC pricing reveals that generic fluticasone/salmeterol 250/50mcg has fallen to $2.62 per inhaler (a 99.2% discount from the brand's historical WAC of ~$340). This erosion demonstrates the steep value collapse that occurs once generic dry-powder inhalers successfully navigate FDA bioequivalence reviews.
• The Ellipta Device Shield: GSK has successfully insulated its newer respiratory franchise by utilizing the Ellipta multi-dose dry powder inhaler device. Primary device patents (such as US Patent 8,534,281, listed under Breo, Anoro, and Trelegy) run until September 8, 2030 (incorporating a 6-month pediatric extension). This device-patent shield prevents generic manufacturers from filing standard ANDAs for the active ingredients alone, preserving Trelegy's pharmacy acquisition cost at $11.12 per dose ($333.70 per monthly inhaler).
• The Dolutegravir Expiry Cliff: ViiV Healthcare's oral HIV franchise faces a significant milestone in October 2027, when the primary patent for dolutegravir (US Patent 8,129,385) expires. Tivicay currently maintains a stable pharmacy acquisition cost of $77.60 per 50mg tablet. The expiration of this patent will allow generic developers to formulate generic dolutegravir. However, GSK’s Dovato (dolutegravir/lamivudine) is protected by a secondary patent (US Patent 11,234,985) extending to January 24, 2031, which blocks generic combination entry and provides a buffer for the oral HIV business.

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FAQ

When did Luke Miels become GSK CEO, and is Emma Walmsley still involved?

Luke Miels was appointed CEO designate in September 2025 and officially assumed the role of GSK CEO on January 1, 2026. Dame Emma Walmsley stepped down from the CEO position on December 31, 2025, but remains on the board of directors as a non-executive director through September 30, 2026 to ensure a stable leadership transition.

Is there an approved Nucala (mepolizumab) biosimilar in the US?

No. As of July 2026, the FDA Purple Book shows that no mepolizumab biosimilars are approved in the United States. The Nucala franchise remains protected by reference product biologic exclusivity and active orphan drug indications (such as EGPA through September 2027). The closest biosimilar candidate, Bio-Thera Solutions' BAT2606, is currently in clinical development and has not yet submitted a 351(k) BLA.

How exposed is GSK to Advair/fluticasone-salmeterol generic erosion?

In 2026, GSK's financial exposure to Advair is negligible. Due to multiple generic entries (there are currently 4 active ANDA applicants) and pharmacy-level substitution, Advair's pricing has eroded completely, with NADAC values falling to $1.85 to $2.62 per inhaler. GSK has successfully transitioned its respiratory volume to the Ellipta device franchise (Trelegy and Breo), which is protected by device and formulation patents through September 2030.

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Sources

1. GSK plc FY2025 Results Announcement: Full-Year and Fourth-Quarter 2025 Results, GSK Press Release, February 4, 2026. GSK Media.
2. GSK plc Annual Report 2025: Annual Report and Accounts 2025, GSK plc, Published March 2026. GSK Reports.
3. Luke Miels CEO Appointment: Luke Miels Appointed CEO Designate for GSK, GSK Press Release, September 29, 2025. GSK Press.
4. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, U.S. Food and Drug Administration, Snapshot July 8, 2026. FDA OB Database.
5. FDA Purple Book: Database of Licensed Biological Products, U.S. Food and Drug Administration, Snapshot July 8, 2026. FDA PB Search.
6. CMS National Average Drug Acquisition Cost (NADAC): Weekly Price File, Centers for Medicare & Medicaid Services, July 8, 2026. Medicaid.gov.
7. Cardinal Health Biosimilar Pipeline Report: 2026 Biologics and Biosimilars Update, Cardinal Health, May 2026.