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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.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD
November 9th 2024A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.
