[Bio Talk] From One Hour to 15 Seconds... IV Infusions Disappearing from Medical Practice

SC Formulation Becomes an Essential Choice, Not Just Patent Defense
Rising Interest in Alteogen... Securing Follow-up Competitiveness Remains a Challenge

The process of getting an injection, which used to take over an hour, is now being reduced to just a few seconds. This is the story of switching formulations from intravenous (IV) medications to subcutaneous (SC) injections.

Until recently, the pharmaceutical industry largely viewed such formulation conversions as a strategy to defend the patents of original products. Once the patent for an existing IV formulation expires, generic drugs or competing products can enter the market. Therefore, the strategy has been to launch a subcutaneous injection with improved patient convenience before that happens, effectively locking patients and prescriptions into the new formulation. Securing a separate patent for the SC formulation also serves to extend the product’s exclusivity period.

Although not incorrect, the recent acceleration of this transition cannot be explained only by these factors. The very nature of subcutaneous injections is changing in clinical settings. Some analysts note that choices previously made by companies to protect their patents are now essential to maintain competitiveness.

Starting at the end of this month, early-stage Alzheimer's patients in the United States will be able to begin treatment at home. This comes as the subcutaneous version of Eisai and Biogen’s Alzheimer’s treatment, Leqembi IQLIK, starts full-scale use in the country. The treatment involves two weekly 250mg injections, each administered in just 15 seconds. Until now, patients had to visit the hospital every two weeks and receive an IV infusion lasting more than an hour.

Last month’s approval by the US Food and Drug Administration (FDA) has been seen as a sign that regulatory authorities now view subcutaneous injections differently. Previously, IQLIK, which was approved in August last year, was used as maintenance therapy after 18 months of IV infusions. The IV infusion was a prerequisite, and the subcutaneous injection was an option offered later for convenience. However, this time, the FDA lowered the threshold, allowing Alzheimer's patients to use it from their very first dose. The decision was based not on a newly designed large-scale clinical trial, but rather on a sub-study of an existing trial. The key finding was that weekly subcutaneous injections achieved the same level of drug exposure as IV infusions. If the exposure is equivalent, it was concluded the effectiveness would also be equivalent.

The rapid pace of conversion to SC formulations is already evident in the numbers. Keytruda Qurex sales soared from $128 million (about 181 billion won) in the first quarter of this year to $463 million (about 654.8 billion won) in the second quarter, a 262% increase in just one quarter. Professors at university hospitals say that what is driving this speed is not patents, but the realities of medical practice. Switching to SC injections allows hospitals to allocate injection room chairs and nursing staff to other patients, and patients themselves save travel and waiting time. If efficacy is the same, both hospitals and patients have no choice but to choose the quicker option.

This is also why market attention is returning to Alteogen. Earlier this month, BlackRock, the world’s largest asset management company, disclosed that it holds a 5.03% stake in Alteogen. The healthcare community views this investment as a recognition that the ongoing changes in clinical practice are not just a passing trend, but a structural shift.

The key enzyme patent for Halozyme, a competitor of Alteogen, will expire in the US in September next year. In addition, two related improvement patents were invalidated by the US Patent Trial and Appeal Board this past May. As the leading player’s patents continue to expire, the barriers to entry for new players are expected to fall, and the focus of competition will likely move to the next stage. The biotech industry is now paying attention to follow-up technology capabilities, such as simultaneous formulation that combines antibodies and enzymes in a single injection for increased stability.

This content was produced with the assistance of AI translation services.