A Difficult Road Ahead for a “Pure-Play” Biosimilar Maker

On May 30, 2016, I wrote a profile on Coherus Biosciences for the Center for Biosimilars. Based in Redwood City, California, Coherus was founded in 2010 to solely focus on the development and commercialization of biosimilar agents. It does not have any agreements to manufacture or license existing approved products. The firm refers to itself as a “pure-play biosimilar platform company.”

Like several other biosimilar makers, it paired up with marketing partners on particular products outside the US, but it reserved its US commercialization for itself.

Fourteen months ago, which can seem like another age in terms of biosimilars, Coherus had extremely positive prospects. It had a deal with Baxalta to market its late-stage adalimumab biosimilar (CHS-0214) in Europe, Canada, and Brazil and with Daiichi Sankyo to market this agent in Asia. Its version of pegfilgrastim (CHS-1701) was nearing FDA application, and its phase 3 clinical studies on etanercept were yielding good results in rheumatoid arthritis and psoriasis. Coherus had a victory under its belt in the continuing patent battle with Abbvie over Humira®. Finally, it had just announced that it would be adding ranibizumab (CHS-3351) and bevacizumaba (CHS-5217) to its biosimilar pipeline. According to the company, it had more than $400 million available to complete its pegfilgrastim FDA application and its ongoing clinical studies for the biosimilar candidates.

Coherus Logo

That was then. In 2016, Shire, which acquired Baxalta, announced that it was returning its marketing rights to the adalimumab biosimilar to focus on rare diseases. As announced in the past week, Coherus laid off 30% of its workforce (51 employees) and lost Daiichi Sankyo as a marketing partner on its etanercept agent, both likely related to FDA’s rejection of its lead biosimilar, pegfilgrastim.

 

 

 

In its March 2017 financial report, Coherus mentions a nonbiosimilar drug candidate for multiple sclerosis in phase 2b studies (CHS-131), which a separate filing indicated that it is seeking another partner to enable the clinical trial program to progress. The latter document indicates that whereas both ranibizumab and bevacizumab are in preclinical development, “Our goal is to advance at least one of these product candidates into clinical trials in 2017.” However, no mention of any of these 3 products are made on Coherus’ product pipeline.

 

Without the ability to utilize revenues from other products to capitalize the biosimilar development and commercialization program, a “pure-play” biosimilar manufacturer is in a precarious position. It is unfortunate that pegfilgrastim was the first Coherus product to reach the approval stage. So far, no other manufacturer (Sandoz or Apotex included) have successfully obtained an approval on pegfilgrastim. In the best case scenario, it may have been able to market pegfilgrastim, which may have provided needed cash if a subsequent product experienced a problem in phase 3 trials or in FDA review. On the other hand, its remaining 2 late-stage products seem promising.

Indeed, it is a difficult road for biosimilar-only manufacturers. Epirus Pharmaceuticals filed for Chapter 7 bankruptcy in July 2016. One can imagine that with Coherus’ assets and progress, a purchase by a major pharmaceutical player could be in the cards. That might be fortunate for Coherus but unfortunate for the health care delivery stakeholders, including consumers, because new, healthy competition in the pharmaceutical arena is needed. I hope that with a new infusion of capital, Coherus can see it through as a stand-alone manufacturer with approved biosimilars to sell.

One thought on “A Difficult Road Ahead for a “Pure-Play” Biosimilar Maker

  1. And Coherus made the huge mistake of signing an agreement with KBI Biopharma’s plant in Boulder, CO to manufacture CHS1701. This KBI plant has NEVER manufactured a Commercial product and had a disastrous FDA PAI in December 2017.

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