Pfizer biosimilar to Roche Herceptin wins USFDA nod

The approval for Pfizer comes nearly a year after the agency declined to approve the drug, Trazimera, and sought additional technical information. The USFDA had declined to approve Pfizer’s biosimilar of Herceptin in April.

New Delhi: 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.

The approval for Pfizer comes nearly a year after the agency declined to approve the drug, Trazimera, and sought additional technical information. The USFDA had declined to approve Pfizer’s biosimilar of Herceptin in April.

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.

Medical Dialogues had earlier reported that USFDA had approved a biosimilar to Roche Holding AG’s blockbuster breast cancer treatment, Herceptin. The biosimilar, Ontruzant, is sold by Merck Sharp & Dohme Corp, a unit of Merck & Co Inc, and is developed by Samsung Bioepis Co Ltd, which is a joint venture between Samsung BioLogics and Biogen Inc.

Also Read: Samsung Bioepis biosimilar to Roche Herceptin wins FDA nod

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. Herceptin is one of the world’s most successful antibody drugs and has been a mainstay of Roche profits for many years. However, sales have been hit by rising competition from cheaper biosimilars, particularly in Europe.

Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision. Their similar versions are called biosimilars, instead of generics.

Pfizer is an American pharmaceutical corporation headquartered in New York City, with its research headquarters in Groton, Connecticut. The company develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, endocrinology, and neurology.

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