Biologic Drugs in Development

Henlius and Organon have secured approval in Europe for its pertuzumab (POHERDY) biosimilar, expanding biosimilar access for HER2-positive breast cancer treatment across oncology settings.

Survodutide delivers significant Phase III weight loss results, FDA grants RMAT status to Orca-Q, and Ligand expands its portfolio with a $739 million acquisition of XOMA.

Biopharma news highlights: Henlius and Organon gain EU approval for a pertuzumab biosimilar, while Pfizer reports Phase 3 success for Elrexfio in multiple myeloma. Genexine advances GX-BP1 targeting SOX2, signaling new progress in overcoming cancer resistance and expanding oncology innovation.

Boehringer Ingelheim announced promising Phase III data showing that survodutide achieved up to 16.6% weight loss and significant metabolic improvements in adults with obesity or overweight. The dual glucagon/GLP-1 agonist may offer a new approach targeting both weight reduction and liver-related metabolic health.

The FDA has granted RMAT designation to Orca-Q, an investigational allogeneic T-cell therapy for high-risk hematologic malignancies, based on early phase 1 data.

Ligand’s acquisition of XOMA Royalty expands the royalty model, supporting late-stage drug development and diversifying access to oncology and rare disease therapies.

The BioPharm Brief covers three recent FDA developments shaping the autoimmune and inflammatory disease landscape. The agency cleared a subcutaneous autoinjector for anifrolumab in systemic lupus erythematosus, enabling at-home administration. It also granted Priority Review to nipocalimab for warm autoimmune hemolytic anemia, highlighting its potential as a targeted treatment for a rare condition. In addition, a supplemental application has been submitted for subcutaneous risankizumab as an induction therapy in Crohn disease, which could reduce the need for infusion-based initiation. Together, these updates reflect a growing focus on patient convenience, expanded access, and more precise treatment approaches in immune-mediated diseases.

Mid-stage data suggest Oruka Therapeutics’ ORKA-001 may deliver high levels of skin clearance with the potential for once-yearly dosing in plaque psoriasis. However, limited study details and lack of safety data make the findings preliminary.

FDA approved a AstraZeneca's subcutaneous anifrolumab autoinjector for adults with moderate to severe systemic lupus erythematosus on standard therapy.

FDA has granted priority review to Johnson & Johnson's nipocalimab for warm autoimmune hemolytic anemia, a rare disorder with no approved US therapies.

AbbVie seeks FDA approval for subcutaneous risankizumab induction in adults with moderately to severely active Crohn disease.

Alphamab Oncology is set to unveil Phase I data for its bispecific ADC JSKN016 at the American Society of Clinical Oncology Annual Meeting (ASCO) 2026 in HER2-negative breast cancer. The early clinical readout highlights encouraging antitumor activity and a manageable safety profile in heavily pretreated patients, supporting continued development across multiple settings.

AbbVie has received a Complete Response Letter from the FDA for trenibotulinumtoxinE (TrenibotE), citing manufacturing-related questions but no safety or efficacy concerns. The company plans a timely resubmission, underscoring continued momentum for this short-acting neurotoxin candidate in facial aesthetics.

Minaris Advanced Therapies’ Dr. Eytan Abraham joins the discussion on how the biopharmaceutical industry is revolutionizing the design, durability, and global scalability of new biotherapeutic modalities through innovations in molecule design and next-generation delivery platforms.

CHMP has supported intrathecal onasemnogene abeparvovec, Novartis' gene therapy for 5q SMA in patients aged 2 years and older in the EU.

Phase 3a PIONEER TEENS data show oral semaglutide significantly improved glycemic control in adolescents with type 2 diabetes, addressing a major unmet need in pediatric care. Novo Nordisk plans regulatory submissions in the US and EU, positioning the therapy as a potential first oral GLP-1 option for this population.

The FDA’s approval of Dupixent (dupilumab) for the pediatric patient population extends the biologic’s use beyond its previous indication in adults and adolescents aged 12 years and older, marking the first biologic option available in the United States for younger children with uncontrolled chronic spontaneous urticaria.

A2 Biotherapeutics will present early A2B694 and EVEREST-2 updates at ASCO 2026 in HLA-A*02 LOH solid tumors.

Dr. Alan Smith of Charles River Laboratories explains why early manufacturing planning and scalable processes are critical to ensure successful commercialization of complex cell and gene therapies as part of his panel discussion at INTERPHEX 2026.

CytoDyn Inc. reported early Phase 2 data at the American Association for Cancer Research Annual Meeting 2026 showing that leronlimab in combination with TAS-102 and bevacizumab demonstrated biomarker activity, including reductions in circulating tumor DNA, in patients with metastatic colorectal cancer.

Johnson & Johnson reported that nipocalimab (Imaavy) demonstrated sustained disease control and reductions in pathogenic IgG levels through more than two years in patients with generalized myasthenia gravis. Patients who achieved sustained minimal symptom expression showed greater quality-of-life improvements, while a new head-to-head trial comparing nipocalimab with another FcRn inhibitor is now underway.

Amneal’s acquisition of Kashiv is expected to advance biosimilar development capacity, which in turn would support access to biologics amid an anticipated wave of loss-of-exclusivity patents globally.

The FDA has accepted Roche’s application for Gazyva/Gazyvaro in systemic lupus erythematosus (SLE), based on Phase III data showing significant reductions in disease activity and improved remission rates. If approved, the anti-CD20 therapy could become the first B cell–targeting treatment for SLE and a potential new standard of care.

AstraZeneca reported that its IL-33-targeting biologic tozorakimab significantly reduced exacerbations in Phase III trials of chronic obstructive pulmonary disease, reinforcing its potential as a first-in-class treatment. The results add to growing evidence that the therapy could address persistent unmet needs in COPD patients who continue to experience exacerbations despite standard care.

Boehringer Ingelheim is expanding its investment in AI for R&D in London to advance computational approaches to disease biology and drug discovery in biopharmaceuticals.