FDA Approves The Mylan NV (NASDAQ:MYL) Biosimilar For Neulasta

Mylan NV (NASDAQ:MYL) has come together with Biocon to make a joint announcement regarding the latest move by FDA to give its approval for Fulphila which fundamentally a biosimilar of Neulasta and it belongs to Amgen, Inc (NASDAQ:AMGN).

The announcement is being looked at as a major boost for the business guru and that is considering the potential market for Fulphilia. According to the IQVIA, Neulasta channeled in about $4.2 billion in terms of the U.S. sales for the past 12months ended March 31, 2018.


It is worth noting that Fulphila is the first FDA-approved biosimilar of Neulasta making the moment a historical one for Mylan NV. The company’s spokesperson has disclosed that in three weeks to come they will be able to unveil the biosimilar.

There was great need to unveil the biosimilar since it was one of the best ways for reducing the duration of febrile neutropenia among the significant number of patients diagnosed with particular types of cancer.

Mylan has lately been so much into strategies with the capacity to broaden its biosimilars portfolio and it goes without saying that the approval is a major step towards achieving the goal. The FDA approval is said to have highlighted nonclinical and clinical data as well as the comprehensive package of analytical. And upon learning that the biosimilar was highly similar to the branded drug it made the much awaited for move.

Comparing Neulasta to the biosimilar product 

One of the analyst revealed that the data brought it out clearly that there were no meaningful differences between the Neulasta and the biosimilar product in terms of potency, purity and safety.

Reports indicate that Mylan owns the product’s commercialization rights in the European Union, New Zealand, Australia, Japan, Canada, in the United States and European Free Trade Association countries.

The two companies sometime ago won the FDA approval for Ogivri which happens to be the biosimilar of Herceptin. A person well conversant with the matter has disclosed that the there are about 30 additional countries where the biosimilar has been approved. Mylan and Biocon are partnering in a quest to come up with about 11 biologic and insulin products.