Picture of an intravenous injection. /Select DB
The pace of conversion of global pharmaceutical companies to subcutaneous (SC) injection formulations for cancer immunotherapy is accelerating. The current intravenous (IV) method of administration into a blood vessel (vein) took a long time to administer, placing a great burden on patients. As an alternative to solve the limitations of intravenous injection, attention is paid to subcutaneous injection, which requires less administration time and is less painful. There is an analysis in the pharmaceutical industry that the subcutaneous injection method is gaining ground in the market faster than expected. It takes about 30 to 60 minutes to administer anti-cancer immunotherapy through the IV method, but the SC method takes 3 to 8 minutes, which can shorten the administration time.
According to the pharmaceutical industry on the 22nd, Halozyme Therapeutics of the US said in a recent earnings conference call that ‘Tecentriq SC’, the world’s first PD-L1 subcutaneous (SC) immunotherapy injection product, was approved in the UK in August last year. , only in the first quarter It was revealed that the vascular injection market moved 18%. At this rate, it will reach 50% within a year.
Halozyme Therapeutics is a company that possesses the original technology for changing SC formulations and has partnerships with several global pharmaceutical companies. ‘Tecentriq SC’ is a new formulation developed by combining Halozyme’s proprietary ‘Enhanze’ drug delivery technology with global pharmaceutical company Roche’s Tecentriq anticancer drug. This technology is based on ‘human hyaluronidase PH20 (rHuPH20)’, an enzyme that breaks the sugar chains in the skin into small pieces and helps drugs to pass through. By increasing the permeability of subcutaneous tissue, it helps the drug to be quickly dispersed in the subcutaneous tissue and absorbed into the bloodstream.
Roche’s HER2 receptor positive breast cancer treatment ‘Herceptin SC’ also achieved 60% conversion within 3 years of launch.
Global pharmaceutical companies with other anticancer drugs also presented goals for conversion to SC formulations one after the other along with performance announcements last year.
Bristol Myers Squibb (BMS) announced that it plans to launch ‘Opdivo SC’ in 2025 and achieve a market conversion rate of up to 75%. Merck announced that it plans to launch the immunotherapy drug ‘Keytruda SC’ in 2025 and aims to convert about 50% of its approximately 40 trillion won sales to the SC formulation by 2028. The Keytruda SC formulation is known to is being developed by the domestic company Alteogen (196170).
Eom Min-yong, researcher at Hyundai Motor Securities, said, “Given the pace of market transformation for the Tecentriq SC formulation, the market transformation for Keytruda SC is expected to accelerate. In this case, the target royalties and sales that can be received after changing Alteogen’s exclusive product contract “We expect that the pace of milestone recognition on achievement will also accelerate,” he predicted.
The acceleration of the change to SC formulations is mainly due to the influence of medical cost reduction policies in countries around the world. Halozyme said, “In Europe, the importance of ‘SC formulations’ is being highlighted to reduce medical costs, and with this awareness, the adoption of SC formulations is progressing.” In the US, there are cases where coverage is automatic, such as through Medicare, but doctors tend to wait for the ‘J code’, which is applied six months after launch, so it the company explains that the change to form SC will continue. in the United States as well.
If pharmaceutical companies want to switch existing anticancer drugs to SC formulations, they must go through a comparative evaluation of efficacy with intravenous administration and a safety evaluation. Experts say that compared to treatments for other diseases, it is not easy to change the way anticancer drugs are formulated.
An industry official said, “As drug delivery technology has developed, it has become possible to change the SC formulation of anticancer drugs. The SC formulation has lower immunogenicity (the ability to induce an immune response) compared to the IV formulation, and the advantage of increased drug effectiveness has also been confirmed, so the transition is happening quickly. “Yes,” he said.
As domestic and foreign pharmaceutical companies develop and release existing intravenous treatments in SC formulations, it is expected to expand the ways for medical staff and patients to conveniently administer medications directly.
In the case of Remsima SC (US product name: Zymfentra), an autoimmune disease treatment drug developed by Celltrion (068270) as an SC form of the IV form of infliximab, it was sold in five major European countries including Germany, the UK , France, Italy, and Spain last year The company announced that it had achieved a market share of around 20% in the third quarter. In Germany and France, it recorded a market share of 37% and 26%, respectively. Together with the existing Remsima, the market share of infliximab in five main European countries is equivalent to around 72%.
A Celltrion official said, “In addition to its therapeutic effect, this product has greatly improved convenience so that patients can self-administer it without visiting the hospital, and as global clinical data continues to accumulate , its competitiveness in the global market is increasing. “
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