FAQ: What You Need to Know about the Current Antibody Pipeline

1. Which next-generation antibody modality is receiving accelerated regulatory designation in oncology development?

FDA’s breakthrough therapy designation was granted to a bispecific antibody-drug conjugate (ADC) candidate, iza-bren, in August 2025 for treating epidermal growth factor receptor-mutant non-small cell lung cancer after prior treatments. This designation, based on promising efficacy and safety data from global and China-based trials, emphasizes the regulatory prioritization of novel ADC mechanisms for challenging cancer indications.

2. How are emerging preclinical strategies accelerating the discovery of novel antibody therapeutics?

Integrated discovery tools and innovative platform technologies are central to early development. In December 2025, GSK and Oxford BioTherapeutics initiated a collaboration to drive antibody-based cancer drug discovery at an industry scale. Furthermore, new biotechnology companies, such as Avidicure, are being launched with substantial seed funding (e.g., $50 million) to develop multifunctional antibody modalities specifically targeting cancer.

3. What major manufacturing collaborations are streamlining the pathway from development to commercialization for antibody therapeutics?

Integrated partnerships are increasingly vital for de-risking the development lifecycle. For example, the Orion–Abzena collaboration in October 2025 focused on streamlining biologics development through integrated antibody manufacturing advances, setting a trend for scalable, risk-reduced production workflows. Additionally, a partnership between Rentschler and Coriolis aims to streamline the entire formulation-to-manufacturing process to de-risk development.

4. What clinical trial data is supporting the commercial viability of monoclonal antibodies (mAbs) targeting Alzheimer’s disease?

Positive Phase III study findings continue to validate anti-amyloid strategies. Lilly’s mAb therapy, Kisunla (donanemab-azbt), showed increasing benefit in slowing the decline for patients exhibiting early symptomatic Alzheimer’s disease in August 2025. This demonstrates ongoing progress in leveraging mAbs for complex central nervous system (CNS) disorders.

5. How are regulators responding to new data for established mAbs in oncology?

Regulatory bodies are validating the efficacy of approved mAbs across multiple hematological and solid tumor indications. Data confirmed the survival advantage of the mAb mogamulizumab in advanced mycosis fungoides and Sézary syndrome in October 2025. Separately, the European Medicines Agency issued a positive opinion in February 2025 for Lynozyfic (linvoseltamab), a Regeneron mAb targeting relapsed and refractory multiple myeloma.

6. What manufacturing infrastructure shifts are supporting the anticipated growth in antibody production capacity?

Major biopharma companies and contract manufacturing organizations (CMOs) are expanding physical and technological capacity to handle future demand. Sanofi, for instance, invested €40 million to strengthen antibody bioproduction at its Lyon Gerland site in France in November 2024. Experts project that CMOs and hybrid companies will collectively hold 54% of global biologics capacity by 2028.

7. How is the biosimilar pipeline impacting the commercial landscape of reference mAbs?

The specialty biologics market is seeing increased competition through licensing and manufacturing agreements. Polpharma Biologics and Fresenius Kabi entered a licensing agreement in August 2025 for PolyPB016, a proposed biosimilar candidate to Takeda’s Entyvio, highlighting strategies to develop and commercialize alternatives to blockbuster mAbs.

8. What advances in drug delivery are increasing patient convenience for subcutaneously administered biologics?

Regulators are increasingly clearing self-administered formats for complex treatments. In December 2025, European regulators authorized AstraZeneca’s anifrolumab pen, a subcutaneous biologic for lupus, advancing the industry trend toward self-injected biologics and decentralized immunology care.