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.

Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars.

Background: Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences between two versions of a biologic. Therefore, this study investigated the batch-to-batch consistency across a range of parameters for released batches of the etanercept biosimilar (SB4) and infliximab biosimilar (SB2).

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.

Patient Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: Findings from a Patient Survey in Europe.

Introduction: Benepali was the first etanercept (Enbrel) biosimilar to be approved in the European Union. Both Benepali and Enbrel are available as autoinjector devices. In a recent survey, nurses from France, Germany, Italy, Spain, and the United Kingdom (UK) reported that their patients with rheumatoid arthritis (RA) would prefer the Benepali autoinjector compared to the Enbrel MYCLIC autoinjector.

Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: A New European Union-Approved Etanercept Biosimilar (Benepali) Versus Etanercept (Enbrel) - Findings from a Nurse Survey in Europe.

Introduction: Enbrel (etanercept: manufactured by Immunex Corporation, Newbury Park, Thousand Oaks, CA 91320, USA) was the first biological disease-modifying anti-rheumatic drug approved for the treatment of rheumatoid arthritis (RA) in Europe. More recently, an etanercept biosimilar (Benepali: manufactured by Biogen Inc, Cambridge, MA 02124, USA) was approved in the European Union. The perceptions and preferences of the Benepali autoinjector versus Enbrel MYCLIC autoinjector were evaluated by nurses from Europe.

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.