Daewoong Pharmaceutical and Dongkook Pharmaceutical, which have led the domestic market for precocious puberty treatments containing leuprorelin, are now subject to a re-evaluation of their generics. If they fail to prove bioequivalence with the original drug by the end of 2027, their marketing authorizations will be canceled. Peptron and LG CHEM, latecomers to this market, have already proven equivalence and are aiming for a turnaround.
According to the industry on the 24th, the Ministry of Food and Drug Safety (MFDS) recently finalized the schedule for the re-evaluation of bioequivalence, by formulation, for domestic generics, held a briefing for corporate officials, and announced detailed deadlines.
Bioequivalence re-evaluation is a process to reconfirm whether generics on the market maintain the same efficacy and safety as the original drug. The MFDS has decided to push forward, from 2026 to 2028, with bioequivalence re-evaluations of generic drugs by formulation, including solution injections, suspension/emulsion injections, eye drops, and ointments.
Among these is the precocious puberty treatment that is a leuprorelin suspension injection. The original drug is Lupron by Japan's Takeda Pharmaceutical. The domestic market for leuprorelin generic formulations is largely a three-way competition among Daewoong Pharmaceutical and its subsidiary HANALL BIOPHARMA, Dongkook Pharmaceutical, and the joint partners LG CHEM and Peptron.
Among them, Daewoong Pharmaceutical's Luphere (depot injection, an injection designed to release the drug slowly in the body) and Dongkook Pharmaceutical's Lorelin (depot injection) are subject to re-evaluation and must prove bioequivalence by the end of 2027.
When Daewoong Pharmaceutical and Dongkook Pharmaceutical received approval for their Lupron generics in the past, the MFDS did not apply bioequivalence requirements. Since then, approval standards have changed, and proving bioequivalence has become mandatory for recent products.
Currently, Dongkook Pharmaceutical has completed the re-evaluation, and Daewoong Pharmaceutical is preparing for it. A Daewoong Pharmaceutical official said, "We plan to begin the clinical re-evaluation of Luphere Depot." Dongkook Pharmaceutical said, "We conducted a clinical bioequivalence re-evaluation and received a 'suitable' judgment from the MFDS last month, and the approval change process remains."
Peptron and LG CHEM are preparing to launch Lupwon, a 1-month sustained precocious puberty treatment that received MFDS marketing approval in Jul. Peptron said, "Lupwon was approved from the outset by proving bioequivalence and was excluded from this re-evaluation list," adding, "Bioequivalence proof for a leuprorelin formulation is also the world's first case."
LG CHEM previously signed a contract with Peptron to secure exclusive domestic sales rights. LG CHEM will hold a launch symposium at the Lotte Signiel Seoul on the 26th and begin a full-scale rollout.
With the bioequivalence re-evaluation system coinciding with a new product launch, observers are watching whether the domestic market landscape will change. For domestic drugmakers, precocious puberty treatments are prescription medicines that contribute significantly to sales and profits, so the re-evaluation results could bring mixed fortunes. An industry official projected, "Depending on the re-evaluation results, some generics may disappear and new formulations could quickly replace products in the market."
The domestic precocious puberty treatment market consists of leuprorelin and triptorelin formulations and is estimated at around 180 billion won. As the number of precocious puberty patients increases, the market is also growing. According to Health Insurance Review & Assessment Service (HIRA) statistics, the number of precocious puberty patients rose 72% over five years, from 108,576 in 2019 to 186,726 in 2023.
According to the medical community and the pharmaceutical industry, a so-called "hybrid height growth therapy," in which growth clinics centered in Seoul's Gangnam administer precocious puberty injections and growth hormone injections at the same time, has also been booming.