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Pipeline 2026: The Movers, the Shapers, & What Matters

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If you're wondering which therapies may influence care delivery, budgets, and decision making in 2026, the pipeline offers an early preview and it points to a year defined by innovation. We're seeing new first in class treatments, thoughtful next generation agents, and a biosimilar market where fewer launches are offset by important competitive shifts driven by recent approvals. John Schoen and Heather Pace from the Center for Pharmacy Practice Excellence join Stacy Lauderdale, Associate Vice President of Evidence-Based Medicine and Drug Information and your Verified RX program host to highlight pipeline agents worth watching and discuss what they may mean for care delivery and spend management in the year ahead.

 

Guest speakers: 

John Schoen, PharmD, BCPS  

Senior Clinical Manager of Drug Information   

Vizient Center for Pharmacy Practice Excellence 

 

Heather Pace, PharmD

Senior Clinical Manager of Drug Information   

Vizient Center for Pharmacy Practice Excellence   

 

Host:  

Stacy Lauderdale, PharmD, BCPS  

Associate Vice President 

Vizient Center for Pharmacy Practice Excellence

 

Show Notes:

[01:01] — Episode Scope

  • The focus is non-CGT therapies; CGT pipeline will be covered in Part 2.

    • [01:50] — Therapeutic Areas With the Most Approvals

    • Oncology leads the pipeline.
    • Others include infectious disease, neurology, rare disease, endocrine, hepatology, dermatology, and rheumatology.

      • [02:37] — Biosimilars in 2026: Momentum or Headwinds?

      • Discussion of potential “biosimilar void”—only 10% of expiring biologic patents have biosimilars in development.
      • Emerging role of PBM private-label biosimilars.

        • [03:51] — FDA Draft Guidance on Interchangeability

        • FDA exploring interchangeable designation for all biosimilars.
        • Potential shift away from clinical efficacy studies in favor of analytical comparisons.
        • Guidance still in draft and open for public comment.

          • [05:34] — John’s Top Picks for First-in-Class Agents

          1. 06:11 — Orviglance
            • First manganese-based, oral MRI contrast agent.
            • Advantages for patients with kidney impairment.
            • Used for liver imaging.

              • [06:20] — Why Non-Gadolinium Matters

              • Lower risk of nephrogenic systemic fibrosis.

                • [06:46] — Tabelecleucel

                • First allogeneic EBV-specific T-cell therapy.
                • For EBV-positive PTLD post-transplant.
                • Could become new standard of care.

                  • [07:42] — Tanruprubart

                  • First therapy specifically for severe Guillain-Barré Syndrome (GBS).
                    • Shows improved outcomes over IVIG and plasma exchange.

                      • [08:20] — Comparing to Standard of Care

                      • Review of improved real-world data outcomes.

                        • [09:03] — Therapies That May Shift Care Delivery

                        [09:32] — Icotrokinra: First oral IL-23 antagonist for plaque psoriasis.

                        [10:00] — Insulin Icodec

                        • First once-weekly basal insulin for type 2 diabetes.
                        • Resubmitted after safety concerns in type 1 diabetes.

                          • [10:59] — Honorable Mentions

                          Camizestrant

                          • SERD for ER+/HER2– metastatic breast cancer.

                            • Ensitrelvir (COVID-19)

                            • Oral option for pre-exposure prophylaxis.
                            • Also being evaluated for treatment.

                              • Doravirine + Islatravir (HIV)

                              • Introduces new NRTTI class.

                                • Cefepime + Zidebactam

                                • Active against metallo-β-lactamase–producing organisms.

                                  • 14:05 — Key Biosimilar Launches

                                  Omalizumab (Xolair)

                                  • First biosimilars in asthma/allergy space.

                                    • Aflibercept (Eylea)

                                    • High competition expected pending litigation.

                                      • Pertuzumab (Perjeta)

                                      • First biosimilar anticipated in oncology.

                                        • [15:31] — Biosimilars Approved in 2025, Impacting 2026

                                        • Ustekinumab (Stelara): first full year of competition
                                        • Denosumab (Prolia/Xgeva): 10–15 biosimilars expected
                                        • Eculizumab (Soliris): notable for rare disease market entry

                                          • [17:17] — John’s Closing Thoughts

                                          • Strong mix of first-in-class advances and next-gen convenience therapies.

                                            • [17:36] — Heather’s Closing Thoughts

                                            • 2026 will focus on speed and scale after the 2025 biosimilar wave.
                                            • Pharmacists pivotal in ensuring smooth patient transitions.

                                              •  

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