Pharmaceutical Industry Embraces Multispecific Antibodies as Next-Generation Therapeutics

The pharmaceutical industry is witnessing a surge in the development and investment of multispecific antibodies (msAbs), signaling a shift towards more complex and potentially more effective therapeutic approaches. This "more is better" strategy is gaining traction in both oncology and autoimmune disease treatment, with several candidates showing promise in clinical trials.

Rapid Growth in msAb Development and Approvals

As of August 2025, the U.S. Food and Drug Administration (FDA) has approved 14 msAbs, with eight of these approvals occurring since 2023. The pipeline for these innovative therapies is robust, with 250 msAb candidates currently in clinical trials, including 24 in late-stage registrational studies.

The first multispecific antibody, Amgen's Blincyto, received FDA clearance in 2014. Since then, the field has expanded rapidly, with two notable blockbusters emerging: Genentech's Hemlibra for hemophilia and Vabysmo for eye diseases. Industry experts predict that at least seven msAb drugs in oncology are on track to achieve blockbuster status by 2030.

Expanding Beyond Oncology into Autoimmune Diseases

While the majority of approved msAbs target various cancers, there is a significant shift in the pipeline towards autoimmune diseases. This expansion is partly driven by encouraging early findings from cell therapies in this therapeutic area.

Peter Bak, a managing director at Back Bay Life Science Advisors, highlighted lupus as a particular area of interest: "Lupus is an area where there's been some interesting data generated by a couple academic groups, and now a lot of companies are rethinking their strategy."

Several pharmaceutical companies are actively exploring msAbs for autoimmune conditions:

• Roche's Lunsumio, already approved for lymphoma, has completed an early-stage trial in lupus.
• Amgen is testing Blincyto in phase 2 trials for lupus with nephritis and refractory rheumatoid arthritis.
• Cullinan Therapeutics' CLN-978 is in phase 1 trials for lupus and rheumatoid arthritis, with initial data expected in the first half of 2026.
• MoonLake Immunotherapeutics is developing a bispecific antibody targeting two forms of IL-17, with phase 3 results for hidradenitis suppurativa expected imminently.

Investment Surge and Market Potential

The promising outlook for msAbs has attracted significant investment. In the first half of 2025, companies focusing on immunology and inflammation msAbs raised $269 million more than their cancer-focused counterparts. This influx of capital reflects the industry's confidence in the potential of these therapies to address unmet medical needs.

Dealmaking activity involving msAbs has also accelerated, with the number of transactions over the past five years comparable to those involving antibody-drug conjugates (180 vs. 192 deals, respectively). This level of interest underscores the perceived value and potential of msAb technologies in the pharmaceutical landscape.

As the field continues to evolve, msAbs face challenges in manufacturing and must prove their worth against other emerging drug development strategies, such as radiopharmaceuticals, protein degraders, and cell therapies. However, the current momentum suggests that multispecific antibodies are poised to play a significant role in shaping the future of therapeutic interventions across multiple disease areas.