Patent expirations could fuel biosimilar growth
New York | 01 July 2013

A significant number of pharmaceutical patent expirations will drive growth opportunities for the global biosimilar market, according to Fitch Ratings.

In its report Trekking the Path to Biosimilars, the rating agency said that the marketplace stands to grow significantly over the course of the decade because eight of the current 20 top-selling global pharmaceuticals are biological drugs set to lose patent protection by 2020.

“Collectively, these eight biological medicines generated approximately $56 billion of worldwide revenues in 2012, or roughly 6.6 percent of the global drug market of $856 billion estimated by IMS Health. As such, the biosimilar pharmaceutical market may grow to $4 billion–$6 billion by 2016, as predicted by IMS Health, from approximately $2 billion presently, fueled by major biological drug patent lapses.”

The European biosimilar industry—the most advanced globally, according to Fitch— “will represent the vast majority of the worldwide marketplace over the next few years given an effective regulatory pathway plus estimated expansion of the marketed biosimilar portfolio beyond today’s twelve treatments for anemia, neutropenia and stunted growth”.

Among the patents set to expire in the EU are Roche’s covering the Non-Hodgkin’s Lymphoma drug Rituxan this year and Pfizer’s Rheumatoid Arthritis treatment Enbrel in 2015.

“Many of the same biological medicines that expired, or face patent expiration, in Europe will suffer the same fate in the US through 2020,” added Fitch.

Patents for two key insulin drugs—Eli Lilly’s Humalog and Sanofi’s Lantus—will expire in the US this year and in 2015, respectively.

“As sponsors contemplate production details for potential biosimilars, the companies must also circumvent the maze of manufacturing process patents protecting the originator biological drugs. The technological and legal difficulties of replicating biological drugs set a high barrier to entry for potential biosimilar sponsors.”

Author: Mark Dugdale

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