Johnson & Johnson

The cell and gene therapy sectors are rapidly advancing, with updates on PepGen's PGN-EDO51 IND hold, innovative payment models for high-cost treatments, Janssen and Legend Biotech's Carvykti showing higher MRD negativity rates, Bristol Myers Squibb and 2seventy bio's Abecma responses in CNS-affected MM patients, Editas Medicine discontinuing EDIT-301 development, and SpliceBio's SB-007 receiving IND clearance for Stargardt disease treatment.

The FDA approved Celltrion's Steqeyma, a biosimilar to Stelara, for psoriatic conditions and IBD. Steqeyma is the seventh biosimilar for Stelara, joining Celltrion's immunology portfolio. It is available in subcutaneous and intravenous forms and is supported by phase III study data showing similarity to Stelara in safety and efficacy.

Johnson & Johnson submitted a type II variation application to the EMA for ibrutinib (Imbruvica) in combination with R-CHOP for treatment-naive mantle cell lymphoma (MCL) patients eligible for ASCT, supported by TRIANGLE trial results showing improved failure-free survival and overall survival rates compared to R-CHOP alone.

Janssen-Cilag International NV submitted a Type II variation application to the EMA for IMBRUVICA® (ibrutinib) in combination with R-CHOP for previously untreated mantle cell lymphoma (MCL) patients eligible for autologous stem cell transplant. Supported by the TRIANGLE study, ibrutinib-based regimens showed improved efficacy over standard care, offering a potential alternative to transplant.

FDA declines approval for J&J's new subcutaneous formulation of lung cancer drug Rybrevant.

FDA approved STEQEYMA based on phase III study results showing high similarity to ustekinumab in safety and efficacy for moderate to severe plaque psoriasis. STEQEYMA is indicated for multiple immune-mediated diseases and joins Celltrion's immunology portfolio.

The US biosimilar market surged in 2024, driven by FDA approvals and looming patent cliffs, with 63 biosimilars approved and 42 launched. Innovator companies like Novartis, Biogen, Pfizer, and Amgen are entering biosimilar development to mitigate sales erosion. Challenges include market access, reimbursement barriers, and HCP/patient perception. Education and transparency are crucial for biosimilar adoption, with AI tools potentially aiding HCPs.

FDA issued a complete response letter (CRL) for subcutaneous amivantamab-vmjw and recombinant human hyaluronidase in NSCLC with EGFR mutations due to manufacturing facility issues, not product formulation or efficacy. The CRL does not affect the current IV amivantamab approval. Johnson & Johnson is working with the FDA to resolve the issue. Subcutaneous amivantamab showed noninferior overall response rate (ORR) vs IV formulation in the phase 3 PALOMA-3 study, with FDA priority review granted in August 2024.

The FDA declined to approve Johnson & Johnson's subcutaneous formulation of Rybrevant for non-small cell lung cancer due to issues detected during a pre-approval inspection, not related to product formulation or efficacy/safety data. J&J aims to resolve the matter quickly.

The 21st IMS annual meeting in Rio de Janeiro discussed MRD testing, high-risk disease, CEPHEUS trial, and off-the-shelf CAR T-cell therapy. Topics included MRD testing's impact, defining high-risk myeloma, and the potential of allogeneic CAR T-cell therapy. CEPHEUS trial showed improved MRD negativity and PFS with daratumumab in myeloma treatment.