OR WAIT null SECS
October 02, 2020
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
August 13, 2020
The company has launched its biosimilar rituximab, Ritucad, for the Indian market.
The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.
The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).
July 01, 2020
Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
May 05, 2020
FDA/FTC collaborate to end false and misleading statements and discuss the future of biosimilars at March 2020 public workshop on a competitive marketplace for biosimilars.
April 08, 2020
Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.
April 01, 2020
Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level.
FDA is encouraging alternative insulins and challenging anticompetitive practices.
February 21, 2020
As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.