Industry Observation: The First Wearable Formulation Approved in the United States by Large Transdermal Factory LTS (1)
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UDENYCA approved this time ® The in vivo injector (OBI) TM has set a new industry standard for the performance, quality, reliability, and patient convenience of wearable injection devices.

Andernach - Leading pharmaceutical technology company LTS LOHMANN Therapy System AG ("LTS") announced today that its client, Coherus BioSciences, Inc ("Coherus"), has launched UDENYCA using LTS Sorrel ® In vivo syringe (OBI) TM wearable drug delivery platform UDENYCA ® Pegfilgrastim cbqv is a non gliptin biosimilar drug that is administered on the second day after chemotherapy to reduce the incidence of infections represented by febrile neutropenia. UDENYCA ® OBI was officially approved by the FDA in December 2023. This device sets new standards for the performance, quality, reliability, and patient convenience of wearable injection devices.

Coherus and LTS have continuously collaborated in various stages of research and development, ultimately obtaining Udenyca ® Approval of OBI dosing system. The new drug delivery equipment platform will help Udenyca ® Patients receive medication treatment in a comfortable home with the aim of reducing their risk of infection after receiving chemotherapy.

Bas van Buyjtenen, CEO of LTS, commented, "This release completes the plan for LTS to enter the biopharmaceutical market, bringing the well-known easy to manage delivery method of LTS into new therapies. We are ready to expand our production capacity to quickly provide this advantageous formulation to all patients."

"The approval from the US FDA is a clear vote of confidence in the SorrelTM platform and an important milestone. Dr. Andrei Yosef, President and General Manager of LTS Device Technologies, stated, 'This release demonstrates our manufacturing and market supply based on market demand.' 'Approval and initiation will accelerate our other collaborative projects running on the same platform, as well as those with future market access partners."

About SorrelTM

SorrelTM technology allows for pre filled, pre loaded, and pre assembled wearable drug delivery devices, providing easy-to-use wearable devices for home management. The SorrelTM platform has a capacity range of 1mL to 50mL and is independent of the main formulation container, allowing for seamless integration into existing products of pharmaceutical companies.

About LTS

The LTS driving philosophy is "we care, we create, we deliver." As a trusted technology partner in the pharmaceutical industry, LTS develops and manufactures innovative drug delivery systems, such as transdermal patches ("TTS") and oral films ("OTF"), as well as wearable drug delivery devices ("OBDS"). LTS's commercial products include over 20 launched products and a diverse pipeline of over 40 development projects targeting various disease indications. The innovation pipeline of LTS includes projects funded by partners as well as proprietary projects funded by LTS. LTS maintains its leading position by continuously improving its core TTS and OTF technologies, as well as advancing emerging drug delivery technologies, including microneedle array patches (MAP) for transdermal delivery of small and large molecules, bioactive substances, and vaccines. LTS, with its SorrelTM wearable drug delivery platform, provides a user-friendly solution for patients to carry out complex drug delivery at home. LTS was founded in 1984 and currently operates in four locations: Andernach, Germany, West Caldwell, New Jersey, USA, S ã o Paulo, Minnesota, USA, and Netanya, Israel. LTS also has a representative office in Shanghai, China.

Lindmik point of view

For a long time, transdermal delivery of active ingredients in biopharmaceuticals has been a peak that many pharmaceutical companies have looked up to and climbed. However, due to the widespread high molecular weight, low stability, and strict storage requirements of biopharmaceuticals, various transdermal delivery technology platforms (such as hot melt adhesives, solvent adhesives, microneedles, etc.) are currently unable to achieve the industrial production quality stability and scale limit required for evaluation.

Image source: Internet

Although UDENYCA ® The brand has previously launched non Gesting injection pens for patients to self administer at home, but the company has still invested huge resources in partnering with LTS to overcome the research and development application project for wearable injection devices. This indicates that the use of wearable transdermal injection delivery methods for high dose macromolecular biopharmaceuticals has feasibility and commercialization opportunities. But it is still early to deny that transdermal microneedles can achieve macromolecular transdermal drug delivery, after all, the production and research and development technology of microneedles are also rapidly developing.

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