Several Hopefuls in Early Stages of Pegaspargase Biosimilar Development

The Center for Biosimilars Staff

Pegaspargase (marketed as Oncaspar), a biologic drug approved by the FDA in 2006 for acute lymphoblastic leukemia (ALL) as a component of multi-agent chemotherapy, has long gone unchallenged by biosimilar candidates. That could soon change, according to information recently reported by the Generics and Biosimilars Initiative (GaBI).

Pegaspargase (marketed as Oncaspar), a biologic drug approved by the FDA in 2006 for acute lymphoblastic leukemia (ALL) as a component of multi-agent chemotherapy, has long gone unchallenged by biosimilar candidates. That could soon change, according to information recently reported by the Generics and Biosimilars Initiative (GaBI).

The drug, according to GaBI, has historic annual sales of approximately $1 billion. As its patents were licensed to Sigma Tau in 1994 (later acquired by Baxalta, then subsequently acquired by Shire), the industry estimates that the drug would have lost its US patent protection in 2006.

Despite pegaspargase’s potential for high returns, biosimilar manufacturers focused on products like adalimumab, infliximab, and trastuzumab have not historically challenged the high-earning drug. Yet several biosimilar manufactures may be ready to take on the high costs and complex development challenges of developing products referenced on this treatment:

  • Last year, Pfenex granted Jazz Pharmaceuticals the right to commercialize it’s early-stage pegaspargase candidate, PF690, which is currently undergoing preclinical and bioanalytical characterization.

  • Argentina’s Amega Biotech is investigating a pegaspargase candidate of its own in ALL.

  • Xbrane Biopharma completed construction of a laboratory last June in an effort to facilitate development of its biosimilar candidate, Xoncane. Xbrane’s investment in this Swedish laboratory is intended to increase the efficiency of its pegaspargase biosimilar development, along with its development of biosimilar products for other high-selling drugs as certolizumab pegol.

Given the fact that each of these biosimilar manufactures is in early stages of development with candidates referencing Oncaspar, Shire will no doubt see continued strong earnings from this therapy as biopharmaceutical developers race to bring its first biosimilar to market.