FDA News

FDA withdraws biosimilar draft guidance following public comments

June 21, 2018
The FDA has withdrawn a draft guidance intended to provide advice for biosimilar sponsors regarding the determination of similarity between the…

ACR releases position statement on pharmacovigilance

June 13, 2018
The American College of Rheumatology has recently issued a position statement on pharmacovigilance, highlighting the importance of monitoring new…
FDA News

FDA approves Fulphila, first Neulasta biosimilar, to prevent infection during cancer treatment

June 4, 2018
The FDA approved Fulphila, the first biosimilar to pegfilgrastim, to decrease risk for infection, as suggested by febrile neutropenia, among patients…

Sandoz obtains positive CHMP opinion for Humira biosimilar

June 4, 2018
Sandoz received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its proposed…
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…