Coherus Biosciences Inc had its shares plunge to low levels as soon as the company announced that it had received a letter of rejection from the U.S. Food and Drug Administration. This document bears the decision regarding the company’s license application for CHS-1701. This is a pegfilgrastim biosimilar candidate that is similar to Neulasta. This is an extremely successful treatment for cancer patients as it helps them to fight infections.
Many Companies Try to Replicate Amgen Success Story
On Monday morning, shares in Coherus Biosciences Inc plummeted by as much as 30%. At the same time, rival Amgen Inc that owns ownership over Neulasta drug climbed in value to $164.19 per share. Last year, Amgen had a record revenue growth thanks to $4.6 billion in sales that came from its new drug alone. This amount represented as much as a fifth of the total revenue for the company. Amgen has many other successful treatments in its possession.
Therefore, many companies tried to replicate this tremendous success through developing a biosimilar candidate of Neulasta. Such drug developers are Redwood City but also Coherus. At the same time, Amgen is getting ready for a competition for its drug in the fourth quarter of 2017. Until then, the company enjoys exclusivity and market domination.
Last year only, FDA repelled several biosimilar copies of the popular drug from Novartis AG and others. At the same time, the agency needs more time to pronounce a decision for similar license pending approvals from Mylan NV and Biocon Ltd.
Coherus Has Six Months to Address FDA Concerns Regarding Its Biosimilar Candidate
However, there are still chances for Coherus to see its drug on shelves this year. The federal agency didn’t ask the company to perform another extensive trial. Instead, the organization has to reanalyze its compound with a more sensitive tool. This gadget is called assay, and it can identify traces of disease or health risk in a sample coming from a patient.
However, this procedure is going to take the company six months. During this time frame, FDA has enough resources to reconsider the license submission coming from Coherus. At the same time, the company has also compiled the same request for its Neulasta copy to enter the European market.
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