Biosimilars

A randomized, double-blind phase 3 study demonstrated the efficacy and safety equivalence of the adalimumab biosimilar candidate CT-P17 to reference adalimumab in patients with moderate-to-severe active rheumatoid arthritis (RA).

Real-world data from the prospective, observational COMPANION-B study showed that the biosimilar SB4 had similar efficacy over 12 months compared with etanercept reference in patients with well-controlled rheumatoid arthritis with stable disease.

The findings of a retrospective study indicate that successive switching from reference to 2 different biosimilars was not associated with clinically significant changes in disease activity and function in patients with inflammatory rheumatic diseases.

Preliminary real-world retrospective data indicate comparable safety profiles for infliximab-dyyb and infliximab in pediatric rheumatic conditions.

Exploratory analyses of a phase 3 trial comparing infliximab-qbtx to reference infliximab in patients with rheumatoid arthritis (RA) indicate that multibiomarker disease activity score may be used as an assessment of biosimilarity instead of conventional disease activity measures.

Interim results from the phase 3 TROIKA trial demonstrate clinical equivalence between the biosimilar HD201 and trastuzumab reference in terms of efficacy, safety, pharmacokinetics, and immunogenicity in patients with HER2-positive early breast cancer.

Real-world data indicate the efficacy and safety profile of the biosimilar trastuzumab-dttb + pertuzumab was consistent with that previously reported for trastuzumab reference + pertuzumab in patients with HER2-positive breast cancer.

A biosimilar is a “highly similar” copy of a biologic drug, but it is not a generic. This definition understandably causes confusion among patients and providers alike, but it is an important distinction, according to Jim Koeller, MS, FHOPA, Professor, Pharmacotherapy, The University of Texas at Austin.

An increasing number of biosimilars have been approved in the United States, but many clinicians are still poorly informed about what constitutes a biosimilar, and what is involved in their unique pathway to approval, said Andrew D. Zelenetz, MD, PhD, Medical Oncologist, Division of ­Hematologic Malignancies, Memorial Sloan Kettering Cancer Center, New York City.

It is estimated that 350 million people worldwide use biologics on a regular basis to treat their medical conditions. These therapies are incredibly innovative and have expanded the arsenal of effective treatment options for cancer, rheumatoid arthritis, and other serious illnesses. However, the high costs of these therapies, although understandable, can create access issues for patients. That is why biosimilars are so important.