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Coherus Terminates 30% of Its Workforce After FDA's Complete Response Letter
Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million.
Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million. Coherus disclosed its restructuring plan to the Securities and Exchange Commission, citing the need to “better align its workforce with the needs of its business” following the CRL.
The California-based drug company had hoped to challenge Amgen—maker of the biosimilar’s reference product, Neulasta—in the lucrative oncology marketplace. Coherus had called Neulasta the largest-selling oncology biologic in the United States, and the CRL for Coherus proved a serious blow to the drug maker’s financial outlook.
News of the company’s layoffs arrived less than 2 months after Coherus reported disappointing earnings for its first quarter after it ended its agreement with Shire over a proposed etanercept biosimilar, known as CHS-0214, for the European market and other territories. In terminating its relationship with Shire, Coherus regained development and commercial rights to CHS-0214.
In the months ahead, Coherus will attempt to put its pegfilgrastim program back on track by addressing the FDA’s concerns about the biosimilar candidate. The company plans to reanalyze a subset of samples with a revised immunogenicity assay and provide further information about its manufacturing process.
While it contends with these challenges with its now leaner workforce, Coherus sees potential good news on the horizon; in May and June, the Patent Trial and Appeal Board (PTAB) ruled in favor of 3 Coherus petitions for inter partes review of core AbbVie patents on the blockbuster drug adalimumab (Humira). PTAB’s rulings clear the way for Coherus to advance its plans for an adalimumab biosimilar that could capture some market share from the world’s top-selling drug.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
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.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
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.
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.
