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Coherus Stock Plummets as FDA Rejects Neulasta Biosimilar
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Coherus Biosciences, Inc. (CHRS - Free Report) shares declined nearly 24% in yesterday’s trading as it announced that it has received a complete response letter (CRL) from the FDA for its biosimilar version of Amgen Inc's (AMGN - Free Report) blockbuster drug, Neulasta. The CRL will delay the potential regulatory clearance for the biosimilar CHS-1701.
Neulasta is used to prevent the chance of infection in patients with non-myeloid cancer who receive anti-cancer therapies.
We note that Coherus’ share price has declined 44.1% so far this year, underperforming the Zacks classified Medical-Biomedical and Genetics industry, which increased 2.3%.
The CRL doesn’t request for additional studies. However, it is primarily focused on a reanalysis of a subset of treated patients for a revised assessment of the biosimilar’s immunogenicity. It also requests for additional information on certain manufacturing related process. .
In its press release, Coherus noted that it will coordinate with the FDA to address the requested information and define a path to get approval for the candidate. The company has also submitted a marketing application for the biosimilar in the EU.
Approval for a biosimilar of Neulasta will offer a huge market potential for the company as Neulasta is a preferred treatment in patients receiving chemotherapy. It generated sales of $1.2 billion in the first quarter of 2017 and $4.6 billion in fiscal 2016.
Neulasta biosimilars are already available in the EU while U.S. companies are currently developing them. The biosimilar of the drug from Mylan N.V. and India-based Biocon Ltd is under review with a decision expected in October this year. The FDA also issued a CRL to Novartis AG’s (NVS - Free Report) generic arm, Sandoz’s biosimilar last year and it is working to resolve the issues.
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
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Coherus Stock Plummets as FDA Rejects Neulasta Biosimilar
Coherus Biosciences, Inc. (CHRS - Free Report) shares declined nearly 24% in yesterday’s trading as it announced that it has received a complete response letter (CRL) from the FDA for its biosimilar version of Amgen Inc's (AMGN - Free Report) blockbuster drug, Neulasta. The CRL will delay the potential regulatory clearance for the biosimilar CHS-1701.
Neulasta is used to prevent the chance of infection in patients with non-myeloid cancer who receive anti-cancer therapies.
We note that Coherus’ share price has declined 44.1% so far this year, underperforming the Zacks classified Medical-Biomedical and Genetics industry, which increased 2.3%.
The CRL doesn’t request for additional studies. However, it is primarily focused on a reanalysis of a subset of treated patients for a revised assessment of the biosimilar’s immunogenicity. It also requests for additional information on certain manufacturing related process. .
In its press release, Coherus noted that it will coordinate with the FDA to address the requested information and define a path to get approval for the candidate. The company has also submitted a marketing application for the biosimilar in the EU.
Approval for a biosimilar of Neulasta will offer a huge market potential for the company as Neulasta is a preferred treatment in patients receiving chemotherapy. It generated sales of $1.2 billion in the first quarter of 2017 and $4.6 billion in fiscal 2016.
Neulasta biosimilars are already available in the EU while U.S. companies are currently developing them. The biosimilar of the drug from Mylan N.V. and India-based Biocon Ltd is under review with a decision expected in October this year. The FDA also issued a CRL to Novartis AG’s (NVS - Free Report) generic arm, Sandoz’s biosimilar last year and it is working to resolve the issues.
Coherus BioSciences, Inc. Price
Coherus BioSciences, Inc. Price | Coherus BioSciences, Inc. Quote
Zacks Rank
Coherus currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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