FDA News

FDA approves Retacrit, an Epogen/Procrit biosimilar, for treatment of anemia

May 15, 2018
The FDA today approved epoetin alfa-epbx, the first epoetin alfa biosimilar, for the treatment of anemia caused by chemotherapy, chronic kidney…

Concerns over nonmedical switching of biologics spur physician guidelines

May 3, 2018
For patients with chronic illnesses, such as rheumatoid arthritis, multiple sclerosis and cancer, the introduction and development of biologic…
FDA News

FDA declines proposed Rituxan biosimilar from Sandoz

May 2, 2018
The FDA has rejected approval of Sandoz’s biologics license application for GP2013, a proposed rituximab biosimilar, issuing Complete Response…
Meeting News

Biosimilars drastically reduced costs, expanded availability in Europe

April 28, 2018
BOSTON — Biosimilar competition in Europe has significantly decreased the cost of medication, and has not only increased biosimilar…
FDA News

FDA declines proposed Rituxan, Herceptin biosimilars from Celltrion

April 6, 2018
The FDA has rejected approval of Celltrion’s biologics license applications for Truxima, a proposed rituximab biosimilar, and Herzuma, a…

Samsung Bioepis, Abbvie settle lawsuit over Humira biosimilar

April 5, 2018
Samsung Bioepis and Abbvie have reached a global settlement agreement regarding the commercialization of SB5, the proposed adalimumab biosimilar for…

Sandoz obtains positive CHMP opinion for Remicade biosimilar

March 23, 2018
Sandoz received a positive opinion the European Medicines Agency’s Committee for Medicinal Products for Human Use for its proposed infliximab…
In the Journals

Switching from Humira to biosimilar Cyltezo safe, effective in RA

March 16, 2018
Patients with rheumatoid arthritis who switched from adalimumab to the biosimilar adalimumab-adbm experienced no significant differences in efficacy…
In the Journals

Biologic use before, during pregnancy not linked to preterm birth

March 15, 2018
The use of biologic medications for autoimmune diseases prior to or during pregnancy is not associated with an increased risk for preterm delivery or…

ACR, physician groups warn HHS against new pricing proposals for biologics

March 14, 2018
The American College of Rheumatology has joined eight other national physician groups in calling on HHS to reconsider a series of new drug pricing…