The Center for Biosimilars Staff


When Withdrawing Etanercept, Patients With Sustained Deep RA Remission Fare Best

September 02, 2019

One recent paper analyzed data from 3 studies on down-titration of etanercept in patients with rheumatoid arthritis (RA) and concluded that patients who have achieved disease control according to a stringent definition have a greater likelihood of remaining in remission after reducing their dose or withdrawing etanercept.

Henlius Investigating Proposed Biosimilar Bevacizumab in Combination With Novel Antibody Targeting PD-1

August 29, 2019

Drug maker Henlius Biotech is recruiting patients for a single-center, open-label, dose-escalation phase 1 clinical trial that will evaluate the safety and tolerability of combination therapy with a biosimilar bevacizumab and an anti–programmed cell death protein 1 (PD-1) antibody in patients with advanced solid tumors.

Ahead of US Biosimilar Etanercept Competition, Amgen Acquires Apremilast

August 27, 2019

Amgen announced yesterday that it will acquire apremilast (Otezla) from Celgene. The small-molecule drug, which inhibits phosphodiesterase 4, specific for cyclic adenosine monophosphate, is an orally administered therapy for patients with psoriatic arthritis and patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Global Coalition of Regulators Voices Confidence in Biosimilars

August 25, 2019

The International Coalition of Medicines Regulatory Authorities, an executive-level coalition of regulators from 29 medicines regulatory authorities from territories including Australia, Brazil, Canada, China, the European Union, and the United States, among others, recently released a statement of confidence in biosimilars.

Dr. Reddy's Launches Bevacizumab Biosimilar in India, Eyes Emerging Markets Next

August 24, 2019

In 2018, Dr. Reddy’s indicated that it expected to initiate clinical studies for the bevacizumab biosimilar to facilitate EU and US regulatory approval, but this week, a company representative told The Center for Biosimilars® in an email that, “currently, we are gearing up for filings in emerging markets for Versavo.”

Study Looks Favorably at Adding Rituximab to Primary Central Nervous System Lymphoma Treatment

August 22, 2019

A recent study suggests that adding rituximab to a high‐dose methotrexate‐based combination chemotherapy could prolong overall survival as well as progression-free survival for patients with primary central nervous system lymphoma, a rare and aggressive form of lymphoma.