Pharmaceutical Industry's Intensifying Competition for 'Medication Convenience'
Daily Pills → Switching to Long-Acting Injections
The global pharmaceutical and biotech industry's competition in new drug development is intensifying with improvements in 'dosing convenience.' Dosing convenience refers to how easily patients can take their medication, and higher convenience leads to increased prescriptions and sales. Accordingly, research and development efforts are underway to convert drugs that were only available as injections into oral medications, and conversely, to change drugs that must be taken daily into injections administered once every few months.
Celltrion recently completed Phase 1 clinical trials of 'RT-111,' an oral biosimilar of the autoimmune disease treatment Stelara, in collaboration with US-based Lani Therapeutics. Stelara was originally developed only as an injectable, requiring patients to receive injections every 8 to 12 weeks, which was burdensome. The plan is to enhance the biosimilar's competitiveness by converting it into a convenient oral pill.
Celltrion has previously achieved notable success through formulation changes. One example is Remsima SC, a subcutaneous injection form of Remsima, a biosimilar of another autoimmune drug, Remicade. The existing drugs in this category are only available as intravenous injections administered at hospitals. Remsima SC is a subcutaneous injection that patients can self-administer at home. After its launch, it quickly gained market share in Europe, and in the US, it has been recognized for its innovation and will be launched as a new drug named Zimpenetra on the 29th.
Curacle is developing 'CU06,' an oral treatment for diabetic macular edema. Diabetic macular edema is a complication of diabetes where the macula, the central part of the retina, swells, and if it worsens, it can severely impair vision. Existing treatments such as Eylea and Lucentis require injections into the white part of the eye, necessitating anesthesia, and many patients fear the injections and avoid treatment. Yu Jae-hyun, CEO of Curacle, explained, "Superior vision improvement effects compared to injectable drugs have been observed in some patients," adding, "This will significantly reduce the pain for patients who currently have to receive injections directly into their eyes."
On the other hand, development is also underway in the opposite direction?converting oral drugs into injectable forms. The idea is that injections with long-lasting effects over several months offer greater convenience than taking pills daily. This approach is already used for schizophrenia treatments, where injectable forms are administered only twice a year, significantly reducing hospitalization and outpatient costs and solving patients' medication refusal issues. Development is also ongoing for chronic diseases and drugs without cures. Inventage Lab, which owns the long-acting injectable platform 'IVL-Drugfluidic,' is collaborating with Daewoong Pharmaceutical on hair loss treatments, with Yuhan Corporation on obesity treatments, and with Chong Kun Dang on dementia treatments.
Formulation change development is used overseas as a strategy to maintain market share for blockbuster drugs nearing patent expiration. Roche received approval in Europe and the UK for Tecentriq SC, a subcutaneous injection form of the immune-oncology drug Tecentriq. While maintaining efficacy, the dosing time was significantly reduced from 30?60 minutes for the original intravenous injection to 7 minutes. Bristol Myers Squibb (BMS) recently completed Phase 3 clinical trials of Opdivo SC for kidney cancer, and MSD plans to complete Phase 3 trials of Keytruda SC by September. In South Korea, Alteogen, which owns a subcutaneous injection formulation platform, plans to develop a subcutaneous injection form of Opdivo through its subsidiary Altos Biologics.
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