Biosimilars

Biologics play a significant role in patient care, but because of the high cost of these medications, they may be inaccessible to patients and increase health care costs.

Draft guidance seeks to enhance equivalence testing for biosimilars.

The 15-page document offers guidance on statistical approaches to evaluating biosimilar similarity.

Sirukumab is an anti-interleukin-6 monoclonal antibody designed to block the IL-6 pathway in a different way than currently approved IL-6 inhibitors.

Results of the case could alter the future of the biosimilar marketplace.

Clinician and patient understanding and access considerations represent the most significant hurdles inhibiting the uptake of biosimilars for inflammatory conditions.

Current policy reduces incentives that would spur a robust biosimilars market, according to the Biosimilars Council.

Top news of the day from across the healthcare landscape.

Biosimilars offer the potential to provide patients with less costly alternatives.

Top news of the week from Specialty Pharmacy Times.

Switching from etanercept to biosimilar was not associated with treatment-emergent adverse events in rheumatoid arthritis.

Marcus H. Snow, MD, of the University of Nebraska Medical Center, discusses the importance of the treat-to target-strategy versus the non-targeted therapeutic approach in patients with rheumatoid arthritis.

There remain significant issues for biosimilars to impact the drug market in the United States.

Biosimilar uptake in the United States still faces significant challenges.

The guidance describes chemistry, manufacturing, and controls postapproval manufacturing changes considered to have minimal potential to adversely affect quality.

Marcus H. Snow, MD, of the University of Nebraska Medical Center, discusses how education and counseling can improve the uptake of biosimilars among rheumatologists and patients.

The launch of a second Remicade biosimilar could open the floodgates to biosimilar competition in the specialty drug market.

New guidelines and standards have facilitated a robust pipeline of biosimilars in the United States.

Renflexis is indicated for the same inflammatory conditions as reference drug infliximab.

Renflexis is a biosimilar of Remicade, which treats inflammatory conditions, including Crohn’s disease, rheumatoid arthritis, and psoriatic arthritis.

Biosimilar to trastuzumab (Herceptin) observed to have no clinically significant differences than the reference product.

Trastuzumab is indicated as an adjuvant therapy for HER2-positive breast cancer, along with metastatic breast and gastric cancers.

New report provides insight into patient awareness and attitudes towards biosimilars.

Biosimilars have the potential to achieve billions in savings, but significant challenges remain.