BENEFIT: real-world effectiveness of SB4 after transition from reference etanercept in rheumatoid arthritis and axial spondyloarthritis.

Objectives: The objective of this non-interventional study was to evaluate the effectiveness and safety of the etanercept biosimilar SB4 (BenepaliTM) following transition from reference etanercept in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA).

Methods: Data were collected from clinical records of adult patients with stable RA or axSpA, in France, Germany, Italy and Spain. Key outcomes included the change from transition to 3 and 6 months in Disease Activity Score 28 (DAS28) for RA or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for axSpA.

The road from development to approval: evaluating the body of evidence to confirm biosimilarity.

Biosimilars are products that contain a similar version of the active substance of an already authorized original biologic medicinal product (reference medicinal product). Their development requires special consideration, as similarity to the reference agent needs to be established through a comprehensive comparability exercise. Given the complex nature of these agents, minor structural differences may emerge, but the process of biosimilarity determination is designed to ascertain that the nature and impact of these differences are not clinically significant.

Biosimilarity Versus Manufacturing Change: Two Distinct Concepts.

As products of living cells, biologics are far more complicated than small molecular-weight drugs not only with respect to size and structural complexity but also their sensitivity to manufacturing processes and post-translational changes. Most of the information on the manufacturing process of biotherapeutics is proprietary and hence not fully accessible to the public. This information gap represents a key challenge for biosimilar developers and plays a key role in explaining the differences in regulatory pathways required to demonstrate biosimilarity versus those required to ensure that a change in manufacturing process did not have implications on safety and efficacy.

Recurrence of extramedullary plasmacytoma of the breast.

We present a rare case of a multiple recurrent extramedullary plasmacytoma of the breast and spine that showed aggressive behaviour without bone marrow involvement. A 29-year-old woman initially presented with extramedullary plasmacytoma of the left breast that was treated with radiotherapy. Shortly after, a recurrence appeared in the right breast, spine, and in both breasts, despite treatment with local and systemic therapy.