(Reuters) – The U.S. Food and Drug Administration said on Monday it approved Pfizer Inc’s biosimilar to Roche AG’s blockbuster breast cancer treatment Herceptin (trastuzumab).
The approval comes nearly a year after the agency declined to approve the drug, Trazimera, and sought additional technical information.
Since then, the FDA has approved a biosimilar to Herceptin from Celltrion Inc, and one developed by Samsung Bioepis Co Ltd, a joint venture between Samsung BioLogics and Biogen Inc.
The FDA has also approved Mylan’s biosimilar of Herceptin.
Herceptin is one of Roche’s top drugs and brought in sales of 6.98 billion Swiss francs in 2018.
However, sales have been hit by rising competition from cheaper biosimilars, particularly in Europe.