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Eye on Pharma: Coherus Says It Could Launch Pegfilgrastim Biosimilar This Year
Coherus has announced that it sees the potential for a mid-year launch of its pegfilgrastim biosimilar.
Last week, when Coherus released its fourth quarter and full-year 2017 financial results, the company provided a look ahead for 2018, and announced that it sees the potential for a mid-year launch of its pegfilgrastim biosimilar.
In June 2017, the company announced that the FDA had issued a Complete Response Letter (CRL) for the drug. The FDA asked Coherus to perform a reanalysis of a subset of samples with a revised immunogenicity assay and to provide additional manufacturing-related process information. The FDA did not request a clinical study of CHS-1701 in oncology patients, however, and did not indicate that additional process qualification lots would be necessary. In its March report, Coherus said it is close to resubmitting its Biologics License Application (BLA) after it receives the minutes from FDA meetings concerning the complete response letter (CRL).
The company says it also hopes to receive approval from the European Medicines Agency for the biosimilar in the second half of 2018.
Coherus also specified goals for the other biosimilars in its pipeline in 2018:
CHS-3351: Proposed Ranibizumab Biosimilar (referencing Lucentis)
- Clinical development of the potential biosimilar is slated to begin this year.
CHS-2020: Proposed Aflibercept Biosimilar (referencing Eylea)
- Pre-clinical development will continue in 2018 for this proposed biosimilar.
CHS-1420: Proposed Adalimumab Biosimilar (referencing Humira)
- Coherus is pursuing manufacturing objectives in order to complete a BLA for submission to the FDA.
- The company is also preparing for a partnership pursuant to a hopeful 2022 launch.
CHS-0214: Proposed Etanercept Biosimilar (referencing Enbrel)
- Coherus says that it expects the United States Patent Trial and Appeal Board (PTAB) to institute 2 inter partes reviews by March 13, 2018 and March 15, 2018, respectively, as it challenges Amgen’s patents covering Enbrel.
In 2017, fourth quarter research and development expenses for Coherus decreased to $31.5 million from $59 million in 2016. When looking at the fiscal year, expenses in 2016 were $254.4 million, and decreased to $162.4 million in 2017.
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