Coherus receives US FDA approval for Neulasta biosimilar, pricing 33% lower

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Kenishirotie)
(Image: Getty/Kenishirotie)

Related tags: Amgen, Mylan, Biocon, Coherus BioSciences, Neulasta

The company will launch Udenyca onto the US market on January 3, 2019, to compete with Amgen’s originator product and Mylan’s rival biosimilar.

Coherus BioSciences’ CEO, Denny Lanfear has told investors that Udenyca (pegfilgrastim-cbqv), a biosimilar to Amgen’s Neulasta, will be priced at $4,175 (€3,683).

Coherus received approval for its biosimilar from the US Food and Drug Administration (FDA) at the end of last week​.

This price tag matches the rate Mylan, alongside Biocon, decided for its own biosimilar, Fulphila, when it launched in June​ this year. It means the two biosimilars have undercut the list price on Amgen’s chemotherapy treatment by 33%.

However, according to Coherus’ Jim Hassard, VP of marketing and market access, the company has a “competitive advantage​” over Mylan with regard to supply.

“We are very proud to say that we do have ample supply to enter the broad marketplace. And again some competitors that have entered the market maybe haven't had that same luxury,”​ he continued.

Focusing on the US market

Neulasta sales reached $4.53bn globally in 2017, with the US market reflecting a larger share of this market at $3.9bn in sales.

According to Lanfear, Coherus is prioritising the US market: “We haven't had too much to say about partnering in Europe, for the time being, as we indicated earlier we had been approached by some parties in Europe. We continue to chat with some folks but I think that the company's best focus is in the US market,” ​Lanfear said.

The firm received European Union marketing approval​ prior to the FDA’s decision but has not yet launched in this region.

This onus on the US is reflected in its manufacturing network​, where the company bases all of its production.

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