In a market long dominated by injection-based treatments for chronic diseases, a series of oral drugs is emerging. As global pharmaceutical companies roll out pills in treatment areas built around injectables, patients are gaining more options.
According to the medical and pharmaceutical industries on the 18th, "Rhapsido" (ingredient remibrutinib), a chronic spontaneous urticaria (CSU) treatment from Swiss drugmaker Novartis, is expected to launch in Korea as early as next month.
Rhapsido is an oral BTK (Bruton's tyrosine kinase) inhibitor that received approval from the Ministery of Food and Drug Safety in April. It is used for adult CSU patients whose symptoms are not controlled with second-generation antihistamines. It entered the market earlier than Korea, with U.S. approval in September last year and European approval in April this year.
◇ Pills instead of shots: Shifts in the chronic spontaneous urticaria treatment market
CSU is a condition in which hives of unclear cause recur for more than six weeks. Antihistamines have been used as the first-line treatment. For patients whose symptoms are not adequately controlled, injectables such as XOLAIR (ingredient Omalizumab), an antibody drug, have been a key treatment option.
XOLAIR and Rhapsido differ in their ingredients and mechanisms of action. XOLAIR is an antibody therapy that targets IgE, an immune substance involved in allergic reactions. Rhapsido, by contrast, is an oral therapy that blocks inflammatory responses by inhibiting the protein BTK. While XOLAIR is administered as a subcutaneous injection once every four weeks, Rhapsido is taken twice daily.
Competition in XOLAIR biosimilars (biosimilar) has also begun, signaling a market shift. OMLYCLO from Celltrion(068270) is the first Omalizumab biosimilar approved in Korea and has also launched in Europe.
As biosimilars enter the existing injectable market and competition intensifies, drugmakers are differentiating by introducing therapies with new mechanisms of action or routes of administration.
The market already includes oral TYK2 inhibitors taken once daily, such as "Sotyktu" (ingredient deucravacitinib) from U.S. pharmaceutical company Bristol Myers Squibb (BMS). Sotyktu began as a psoriasis treatment and expanded its indication to psoriatic arthritis.
A similar trend is seen in migraine treatment. Oral CGRP therapies, such as "Aquipta" (ingredient atogepant) from U.S. drugmaker AbbVie, now compete alongside injectable antibody therapies. Aquipta is also broadening its use from preventive treatment of migraine to acute treatment.
◇ Making injections shorter and simpler
Across global pharma, formulation competition is spreading to reduce patients' treatment burden, either by switching to pills or, if injections are used, by cutting administration time and frequency.
A representative example is the subcutaneous formulation of the cancer drug "Keytruda" from U.S. Merck (MSD), which applies formulation technology from Alteogen(196170). Instead of intravenous infusion by clinicians, the drug is administered under the skin.
Taking it a step further, there is a case where the injection device itself has been changed. French pharmaceutical company Sanofi developed the subcutaneous formulation "Sarclisa Escena" (Sarclisa Escena, ingredient isatuximab) of the multiple myeloma treatment "Sarclisa" (Sarclisa) and received U.S. FDA approval in July.
This formulation can be administered using an on-body injector, a device attached to the skin that automatically delivers the drug subcutaneously. It is the first cancer therapy in the United States to be administered via an on-body injector.
If Keytruda SC represents a switch from intravenous to subcutaneous injection, Sarclisa Escena adds an "automatic injection device" on top of that. It is characterized by reducing the burden on patients of spending long hours at the hospital receiving injections.
Roche of Switzerland offers the ophthalmic treatment "Susvimo," a long-acting formulation that reduces dosing frequency by implanting a device that continuously delivers the drug into the eye. Patients with wet age-related macular degeneration can refill the drug once every six months instead of monthly injections.
In the obesity treatment market, Novo Nordisk and Eli Lilly and Company are each introducing oral therapies, adding pills to the glucagon-like peptide (GLP)-1 market that has centered on injections.
As competition intensifies with biosimilar entries, big pharma is pursuing differentiation strategies by emphasizing new mechanisms of action and formulations. In particular, because chronic diseases require long-term treatment, patients' dosing convenience can influence drug choice and treatment outcomes.