Dive Brief:
- The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of three biosimilar competitors to Amgen's Neulasta: Mylan and Biocon's Fulphila; Cinfa Biotech's Pelmeg; and Sandoz's Ziextenzo.
- The EMA committee's recommendations are typically a strong sign for future approval, although not binding. These will be the first true biosimilars to Neulasta to be launched in Europe. Teva Pharmaceutical picked up European marketing authorization for Lonquex (lipegfilgrastim) in August 2013, but this was sold as a novel branded biologic after going through a full clinical development program.
- The three biosimilars, and Neulasta, are indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.
Dive Insight:
Amgen faces a financial challenge with its Neulasta (pegfilgrastim) franchise, according to a financial forecast from the investment bank Leerink earlier this month.
Neulasta has historically made up around 20% of the company's total sales, and one analyst projected that these will be cut in half by 2022.
Neulasta sales were $948 million in the U.S. in the second quarter of 2018, and $152 million in the rest of the world. According to IQVIA, the drug had brand sales of more than $450 million in Europe for the 12 months ending June 30, 2018.
Yet competitors to Neulasta are piling up.
Back in July 2018, Coherus BioSciences picked up a European recommendation for Udenyca (pegfilgrastim-cbqv), its copycat candidate, and a final decision is expected in October, which Cowen analyst Ken Cacciatore called "simply a formality."
Depending on the EMA, Udenyca could become the first pegfilgrastim biosimilar to gain marketing authorization in Europe. Udenyca also has a Prescription Drug User Fee Act date of Nov. 3 in the U.S., and Cacciatore sees the European recommendation to bode well for this decision.
Mylan and Biocon's Fulphila (pegfilgrastim-jmdb) in June became the first Neulasta biosimilar to gain approval in the U.S. in June.
Manufacturing problems, though, have led to challenges for the pegfilgrastim biosimilars.
In October 2017, the Food and Drug Administration turned down Amgen and Biocon's application in a Complete Response Letter that requested more chemistry, manufacturing and controls data.
And in August 2017, Mylan withdrew Fulphila's application for a marketing authorization because it could not obtain a good manufacturing practices certificate for site that produced the drug. Fulphila's application was resubmitted in November 2017, following corrective and preventive actions.