FDA Rejects Mylan and Biocon's Pegfilgrastim Biosimilar

Indian drug maker Biocon announced today that the FDA has issued a Complete Response Letter (CRL) for Biocon—Mylan’s proposed pegfilgrastim biosimilar, MYL-1401H, referenced on Neulasta.

Pegfilgrastim is a long-acting version of filgrastim; while biosimilars of filgrastim are approved in the United States and in the European Union, to date, no biosimilar developer had been successful in gaining regulatory clearance in either region for the more complex long-acting drug. One of the challenges of developing pegfilgrastim has been the presence of the polyethylene glycol (PEG) molecule, which is bonded to filgrastim and slows the rate at which the drug is metabolized.

Biocon indicates that the CRL for the drug relates to “data from facility requalification activities” after recent modifications to its manufacturing plant, and that the CRL did not raise questions concerning the drug’s biosimilarity, pharmacokinetic or pharmacodynamic data, clinical data, or immunogenicity. Biocon—Mylan had previously withdrawn an application for the same drug from the European Medicines Agency (EMA) after a French National Agency for Medicines and Health Products Safety (ANSM) inspection that found 35 deficiencies—11 of them major—in Biocon’s manufacturing practices at its Bangalore manufacturing plant. While the companies plan to resubmit their application to the EMA after a re-inspection of the facility, they have not issued a statement as to when they plan to resubmit a Biologics License Application for the drug to the FDA.

Some stakeholders are hopeful that an eventual approval of a biosimilar pegfilgrastim could produce significant savings for health plans. Molly Billstein Leber, PharmD, BCPS, FASHP, and manager of medication policy and formulary management for the Yale New Haven Health System, told The Center for Biosimilars^® in an e-mail, “If insurance companies will reimburse for the biosimilar product, it will be a huge cost savings to the health system. The majority of pegfilgrastim usage is outpatient, so the acceptance rate will be closely tied to reimbursement.”