Cadila to Seek FDA Approval of Pegfilgrastim Biosimilar by 2019

India-based drug manufacturer Cadila Healthcare has announced that it is planning to file a Biologics License Application (BLA) for its biosimilar pegfilgrastim with the FDA by the end of 2019. To date, no developer has been successful in gaining regulatory approval in the United States or European Union for biosimilars of the reference pegfilgrastim.

Cadila’s proposed biosimilar references Amgen’s innovator product, Neulasta, which brought in about $4.5 billion in global sales last year. One of the challenges of developing a biosimilar pegfilgrastim is the presence of polyethylene glycol (PEG) molecule, which is bonded to filgrastim and slows the rate at which the drug is metabolized. Cadila’s proposed biosimilar is currently undergoing a phase 1 clinical trial where it is being tested in healthy volunteers for safety.

“We are discussing to do more [biosimilars for regulated markets],” said Sharvil Patel, managing director of Cadila Healthcare, as reported by Indian media. Meanwhile, Patel said, the company is planning to “aggressively push its biosimilars in semi-regulated emerging markets to boost revenues.” Cadila expects its biosimilar sales to have the potential to reach $500 million in the next 5 to 7 years, a large increase from the $45 million it currently produces.

Cadila is familiar with the development process of biosimilars, as it has already launched 8 such products in India. However, the FDA biosimilar regulatory pathway is among the most stringent in the world, and differs significantly from that in India.

Fellow Indian drug developer Biocon, together with partner Mylan, also filed a BLA for a biosimilar pegfilgrastim with the FDA, however, the application received a complete response letter (CRL) in October relating to “data from facility requalification activities” after recent adjustments to its manufacturing plant. Biocon said that the CRL did not raise question concerning the drug’s biosimilarity, pharmacokinetic or pharmacodynamic data, clinical data, or immunogenicity. Reportedly, the manufacturers are hopeful to re-file later this year.