The marketing of many biosimilars has met resistance in the U.S. recently as FDA sent CRLs for them. According to statistics, FDA has approved 9 biosimilars since March 2015. I’d like to analyze the market data of the marketed biosimilars here.

I. The marketed biosimilars in the U.S.

There have been 9 biosimilars marketed in the U.S. so far, including 1 biosimilar of Filgrastim, 3 biosimilars of Infliximab, 1 biosimilar of Etanercept, 2 biosimilars of Adalimumab, 1 biosimilar of Bevacizumab, and 1 biosimilar of trastuzumab, with the information as follows:

From the above table, we can see that among the 9 biosimilars approved, only 3 drugs have entered the market, 3 drugs were settled with the patent drug companies, and others are in litigation.

II. Market data of Zarxio, Inflectra and Renflexis

The market share of Neupogen® (filgrastim) has been less than 10% due to the marketing of pegfilgrastim, and Neupogen is confronted with the biosimilar competition: Novartis’ marketed Zarxio continues to squeeze the market share of Neupogen.

There have been 2 biosimilars of J & J’s Remicade on the market, therefore, Remicade’s sales have started to decline: its sales in the U.S. will decline by about 10%, and the trend of its sales decline outside the U.S. will be more evident.

Many multinational pharmaceutical enterprises have been involved in the biosimilars, there have been many biosimilars of blockbuster monoclonal antibody drugs in later stages of clinical trial or review, and FDA is actively promoting biosimilar review and striving to remove obstacles to biosimilar marketing. Monoclonal antibody drugs will benefit more patients as more and more biosimilars are marketed.

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