Biosimilar Makers Push Forward on Regulatory and Commercial Fronts

FDA Approves Ranibizumab-hkdz as First Interchangeable, Available in Both Vials and Prefilled Syringes

June 17th 2026

By Cyrus Karkaria, PhD

The FDA has approved ranibizumab-hkdz (Ranluspec; Lupin Limited) as an interchangeable biosimilar for wet AMD, DME, DR, RVO, and mCNV.

Biosimilar Switching Maintained Disease Control in People With Ankylosing Spondylitis

June 16th 2026

By Skylar Jeremias

Evidence shows biosimilars switching in ankylosing spondylitis maintains disease control with biologics, cuts costs, and highlights nocebo risks.

FDA Approves First Biosimilars Interchangeable With Simponi/Simponi Aria

June 10th 2026

By MHE Staff

Immgolis and Immgolis Intri have the same indications as Simponi and Simponi Aria, treating patients with rheumatoid arthritis and ulcerative colitis. The biosimilars will be available in the fourth quarter of this year.

Biosimilar Adoption and Provider Performance in Medicare Value-Based Payment Models

June 9th 2026

By Basit Chaudhry, MD, PhD

Evidence suggests that adoption of oncology biosimilars in Medicare value-based payment models has produced substantial cost savings and improved provider financial performance.

FDA Approves Immgolis and Immgolis Intri as First Biosimilars to Golimumab Reference Products for RA and UC

June 8th 2026

By Kennedy Ferruggia

FDA approval clears interchangeable golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, promising lower-cost TNF therapy.

No Efficacy Loss After Multiple Ustekinumab Biosimilar Switches in Psoriasis

April 2nd 2026

By Giuliana Grossi

Real-world study shows plaque psoriasis stays controlled after 2 ustekinumab biosimilar switches, with stable labs and no serious adverse events.

FDA Approves Teva Biosimilar for Denosumab in Osteoporosis

March 31st 2026

By Sabrina McCrear

The FDA approved Teva’s biosimilar for denosumab, and the FDA and EMA accepted its asthma biosimilar application for review.

Bone Health in Oncology: Closing Gaps, Reducing Costs, and Unlocking Biosimilar Value

March 30th 2026

Biosimilar CT-P43 Matches Ustekinumab in Treating Moderate to Severe Plaque Psoriasis

March 20th 2026

By AJMC Staff

A phase 3 clinical trial found that the ustekinumab biosimilar CT-P43 demonstrated equivalent efficacy, safety, and immunogenicity to reference ustekinumab in patients with moderate to severe plaque psoriasis.

Golimumab Biosimilar Matches Reference Drug in Year-Long RA Trial

March 19th 2026

By Skylar Jeremias

One-year trial shows AVT05 golimumab biosimilar matches Simponi in rheumatoid arthritis, including switching, with comparable safety and immunogenicity outcomes.