Biosimilars

The approval marks the fourth biosimilar approved for ustekinumab, for all approved indications.

To date, biosimilars have supported 495 million incremental days of therapy that patients would otherwise not have received.

MYL-1701P showed equivalent efficacy, with comparable safety and immunogenicity, to reference aflibercept in the Phase 3 INSIGHT trial.

Participants in a study in China also experienced comparable safety and immunogenicity.

The biosimilars month in review highlights recent data demonstrating clinical equivalence and efforts to improve their access.

Patients receiving Humira or Hulio had the highest satisfaction levels across different measures.

There were no significant differences in the overall incidence of AEs and serious AEs.

Adoption rates of infliximab biosimilars only sped up after introduction of a third biosimilar.

Both treatment arms experienced significant improvements in measured parameters from baseline, although these were not all statistically significant.

A ranibizumab biosimilar lowers costs compared with aflibercept across all nAMD subtypes from both the patient and societal perspectives.

Adalimumab-aaty was FDA approved on May 23, 2023, and became commercially available in the US on July 2, 2023.

A total of 82.3% of patients in the biosimilars group and 90.9% in the reference drug group achieved an ACR20 response.

The biosimilars month in review highlights recent FDA approvals and emphasizes new data demonstrating clinical equivalence and the potential impact on treatment options.

Primary and secondary pharmacokinetic parameters through day 75 were similar across treatment arms.

The approval was based on the clinical, non-clinical, and analytical data proving eculizumab-aagh's bioequivalence to the reference drug.

Adalimumab-adbm is now available at a 92% discount from the reference drug list price through GoodRx.

Health literacy was categorized as problematic in 36.2% of patients and insufficient in 15.1%.

The mean percentage change from baseline in lumbar spine bone mineral density was comparable between treatment groups at 18 months.

The biosimilars month in review underscores the efficacy and safety of biosimilars in rheumatology, including recent studies supporting the growing confidence in these treatments across disease spaces.

The study demonstrated clinical similarity between the proposed biosimilar and the reference products.

Robust clinical data showed ustekinumab-ttwe demonstrated similar safety and efficacy compared with the reference product.

Aflibercept-mrbb showed comparable safety, efficacy, pharmacokinetics, and immunogenicity compared with the reference product.

At 8 months follow-up, 86.0% of patients with rheumatoid arthritis were in remission and 94.2% exhibited low disease activity.

Phase 3 data presented at EULAR found the biosimilar CT-P47 is similar to its reference product, tocilizumab, regarding efficacy, safety, and immunogenicity.

After a biosimilar introduction, the prices of the biologic products—namely, trastuzumab, infliximab, bevacizumab, adalimumab, filgrastim, and pegfilgrastim—were significantly reduced.

Disease activity was similar between patients with JIA undergoing a non-medical biological switch and those continuing the originator anti-TNF product.

The Council recommends the elimination of unnecessary clinical efficacy trials and establishing global regulatory comparators.

The biosimilars month in review highlights recent FDA approvals and successful comparison trials.

At 1 year, patients with treated with IL-23 switched or swapped biological treatment less frequently compared with IL-12/23, IL-17, and TNF-α inhibitors.

Healthcare professionals who were aware of the safety and efficacy of biosimilars were more likely to prescribe or switch patients to a biosimilar.