The BioPharm Brief: Advancing ADCs, Biosimilars and CAR-T Therapies

Welcome to The BioPharm Brief, your daily snapshot of the latest developments shaping biopharmaceutical research, clinical progress, and drug development. Today’s update looks at new FDA breakthrough designations for a targeted cancer therapy, expanded biosimilar manufacturing capacity, the US launch of an interchangeable biosimilar, and a setback for allogeneic chimeric antigen receptor T cell (CAR-T) therapy development.

AbbVie’s investigational antibody-drug conjugate (ADC) Temab-A has received 2 FDA breakthrough therapy designations, covering colorectal cancer and non-small cell lung cancer. The c-Met-directed ADC combines a monoclonal antibody with a topoisomerase 1 inhibitor payload. In a heavily pretreated colorectal cancer population, Temab-A produced a 15.6% overall response rate and a 74.6% disease control rate. The designations could help accelerate development of a targeted approach for patients with limited treatment options, although the therapy remains investigational.

Moving from clinical development to manufacturing, Alvotech has partnered with LOTTE Biologics to produce drug substance for multiple antibody biosimilars at LOTTE’s 40,000-L Syracuse, NY, facility. The agreement expands Alvotech’s US manufacturing footprint and global supply network, although the specific products and commercial timeline have not been disclosed. Commercial supply will depend on technology transfer, manufacturing qualification, and regulatory approvals.

That focus on expanding biosimilar supply also connects with the US launch of Omlyclo, Celltrion’s omalizumab-igec. The FDA-approved interchangeable biosimilar to Xolair is now commercially available across 4 approved indications, including asthma, chronic rhinosinusitis with nasal polyps, food allergy, and chronic spontaneous urticaria. Its availability adds another treatment option in allergy and immunology and could expand access to an established biologic therapy.

Meanwhile, Caribou Biosciences is discontinuing development of its allogeneic CAR-T programs vispa-cel and CB-011 while evaluating strategic alternatives, including a potential sale or merger. The decision reflects financing challenges facing allogeneic CAR-T despite encouraging early clinical results, underscoring the gap between promising cell therapy data and the capital required to advance programs toward late-stage development.

These latest developments highlight how clinical evidence, regulatory decisions, manufacturing capacity, and financing conditions continue to shape which therapies advance through the biopharmaceutical pipeline.

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Key takeaways

• Temab-A earned 2 FDA breakthrough designations for difficult-to-treat solid tumors.
• Alvotech and LOTTE Biologics are expanding US capacity for antibody biosimilars.
• Omlyclo expands interchangeable biosimilar options, while Caribou’s exit highlights challenges for allogeneic CAR-T development.