Peptron to launch generic Leuprolide
Peptron announced that it has successfully established bioequivalence of "PT105," once-a-month injectable leuprolide for the treatment of prostate cancer, breast cancer, endometriosis and precocious puberty.
Takeda's Leuplin, the original drug for PT105, has achieved a total of $1.34 billion in sales and the largest global market share over the past 30 years, the company said.
[Read more: Amneal receives FDA nod for leuprolide acetate injection]
Material, composition and use patents have expired, but Peptron obtains full equivalence due to the difficulty in generic drug development of emulating Takeda's manufacturing process and technology, the company noted.
"Compared to Takeda's Leuplin, PT105 has reduced particle size and smaller needle gauge, which will improve patients' convenience," said a Peptron spokesperson. "Together with comparative advantage and large-scale producibility in our Osong GMP facility, we will quickly expand and strengthen our position."
"After the launch of PT105 in the domestic market, we will enter the global market with potential partners based on established bioequivalence and international standards." said Ho-il Choi, CEO of Peptron. "Together with PT320 that secured the FDA's Phase 3 clinical trial IND approval, PT105 is a success milestone that proves the superiority of Peptron's SR formulation technology and commercialization capabilities."
[Read more: Aurobindo obtains FDA OK for generic Lupron]
Peptron said it expects to enter into the domestic and global market with 1-, 3- and 6-month formulations of generic Leuprolide.