OR WAIT null SECS
May 29, 2018
The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).
May 16, 2018
The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).
Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.
May 15, 2018
Naturally occurring and engineered albumins are being explored as a tool to enhance the stability of drugs, including biologics, and extend shelf-life.
May 14, 2018
Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.
May 08, 2018
The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.
May 07, 2018
The data and analytics company reports on the anticipated uptake of Humira (adalimumab) biosimilars in the EU once they are launched in 2018.
April 30, 2018
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
April 09, 2018
Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
April 05, 2018
The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.