Sourcing of Biologics and Reference Listed drug from South Korea

Introduction

In the ever-evolving pharmaceutical landscape, the demand for biosimilars and generic medicines is experiencing a significant surge. Despite variations in uptake rates among different products, biosimilars are swiftly gaining momentum, presenting lucrative opportunities for pharmaceutical innovation. Notably, the South Korean Government has committed substantial investments to propel the biosimilar industry forward, with ambitious goals of capturing a substantial 22% share of the global market by 2020.

In response to this, Invimeds, a reputable player in pharmaceutical procurement, takes proactive steps to streamline the sourcing process for Reference Listed Drugs (RLD) and biologics. These drugs are pivotal for advancing research and development (R&D) initiatives in biosimilars and generic medicines. Leveraging our extensive expertise and global network, we ensure seamless access to premium-quality RLDs sourced from South Korea, enabling their widespread distribution to markets worldwide. This strategic approach facilitates the progression of biosimilar and generic medicine endeavors with unparalleled precision and efficiency.

Market Growth And Projections:

The South Korean biosimilar market is poised for remarkable growth, with a projected compound annual growth rate (CAGR) of 21.6% from 2023 to 2027. By 2027, it is estimated to reach a value of US$1,160.3 million, a significant increase from its 2023 value of US$531.5 million. This growth trajectory reflects a robust CAGR of 23.1% over the past five years, primarily attributed to the strong support of the South Korean government towards the biosimilar industry.

The government’s strategic backing aims to secure a substantial share of the global biosimilar market by 2020, fostering an environment conducive to significant and rapid expansion in the upcoming years.

Government Support and Policy Impact:

In 2016, the South Korean biosimilar market was valued at around 150 billion won (~$130 million), indicating a promising foundation for growth. Since 2012, six biosimilars have received approval, with numerous others in various stages of development. To further bolster this burgeoning industry, the government has made considerable investments in domestic biopharmaceutical companies.

The investments made by the government encompass not only financial backing but also regulatory guidance, providing valuable assistance to biopharmaceutical companies as they navigate the intricate approval processes for biosimilars, both within South Korea and on the international stage. This support highlights the government’s allegiance to nurturing innovation and enhancing competitiveness within the biosimilar sector, solidifying South Korea’s position as a pivotal player in the global pharmaceutical arena.

Overview of MFDS Regulations and Guidelines Of South Korea

Regulatory oversight of RLD sourcing in South Korea falls under the purview of the Ministry of Food and Drug Safety (MFDS). This governing body plays a pivotal role in ensuring the safety and efficacy of pharmaceuticals within the country, serving as a gatekeeper for drug approval processes. Compliance with the MFDS’s stringent regulations and guidelines is paramount for companies navigating the intricate landscape of drug approval, particularly for those entering the South Korean market. Understanding and adhering to MFDS procedures are essential prerequisites for successfully introducing drugs into this highly regulated environment.

Regulatory Framework for Biologic Products in South Korea

South Korea implements a hierarchical legal structure comprising acts, regulations, and guidance to govern its laws. The Ministry of Food and Drug Safety oversees cellular therapies regulation primarily through the Pharmaceutical Affairs Act (PAA), categorizing cellular therapy products as biological products.

Within the PAA framework, regulations and guidelines provide detailed oversight for biologic products, including seven regulations and eight guidelines. Key regulations granting marketing authorization for biological products include those governing the review and authorization of biological products and the investigation of new drug applications for medicinal products.

Strategies for Collaboration with Local Regulatory Experts

To traverse the Korean MFDS regulatory landscape effectively, international companies must adopt strategic approaches. Collaborating with local Korean regulatory experts offers valuable insights and guidance, aiding in compliance with MFDS policies. Partnering with experienced Korean drug regulatory entities can provide specialized expertise, assistance with documentation, and ensure regulatory compliance.

Continuous Monitoring of Policy Changes for Regulatory Compliance

Remaining informed about evolving drug registration policies in Korea is crucial for regulatory compliance and competitiveness. Continuous monitoring of policy changes ensures adherence to Korean MFDS regulations. Familiarity with registration procedures and adapting to regulatory changes are vital for success in this growing market.

Invimeds Facilitating RLD and Biologics Procurement from South Korea

At Invimeds, we specialize in providing end-to-end solutions for procuring biologics and RLDs, with a focus on efficiency, reliability, and compliance. Our unique proposition lies in our ability to offer tailored solutions that align with the specific requirements of clients operating in the South Korean pharmaceutical market.

Streamlining the Procurement Process:

Invimeds Health provides a streamlined procurement experience through our intuitive platform, empowering users to optimize their operations seamlessly. Our user-friendly interface enables effortless order placement, tracking, and management, while strict adherence to EU-GMP standards ensures a reliable global medication supply. With a focus on strategic planning and transparent communication, we facilitate a professional and efficient procurement process for our clients.

Our Strengths:

Invimeds boasts several strengths that set us apart in the industry:

Expertise: Our team comprises experts with in-depth knowledge of the pharmaceutical industry and regulatory landscape in South Korea. This expertise allows us to navigate complex requirements with ease and precision.
Network: Over the years, we have built a robust network of trusted suppliers and partners, both domestically and internationally. This network enables us to source high-quality biologics and RLDs efficiently and cost-effectively.

Invimeds Health stands at the forefront of providing access to a comprehensive range of biologics, leveraging our extensive network of trusted suppliers across key regions, including the USA, EU, Korea, Latin America, Japan, and notably, South Korea. Within our network, every supplier undergoes meticulous selection, ensuring adherence to the highest standards of quality and reliability.

Our expertise extends to sourcing biologics from South Korea, where we are well-versed in navigating the intricacies of the market to procure genuine Reference Listed Drugs (RLDs). With a deep understanding of the regulatory landscape and a commitment to upholding stringent standards, Invimeds Health ensures that all products sourced from South Korea undergo rigorous vetting processes and comply with regulatory standards, offering our clients access to biologics of unparalleled quality and authenticity.

Compliance: Compliance is at the forefront of everything we do at Invimeds. We adhere to the highest standards of quality and regulatory compliance to ensure that our clients receive products that meet stringent regulatory requirements.

We forge strong partnerships with reputable RLD suppliers in South Korea, ensuring seamless access to high-quality biologics that meet stringent regulatory standards. We prioritize compliance by obtaining essential permits and approvals for importing controlled substances and provide certifications like Certificates of Analysis (COA), Batch Reports, and Certificates of Origin (COO) to ensure authenticity.

Furthermore, Invimeds Health extends its commitment to compliance with WHO EU guidelines, FDA, and EMA regulations to include sourcing from the South Korean market. With our rigorous oversight spanning from product selection to delivery, we maintain the highest standards of quality and reliability in procuring Reference Listed Drugs (RLDs) from South Korea. By adhering to stringent regulatory requirements and obtaining necessary certifications, Invimeds Health ensures the authenticity and safety of all products sourced from this market.

Our dedication to transparency and regulatory compliance fosters trust among clients and regulatory bodies alike, underscoring our unwavering commitment to delivering top-tier RLD to pharmaceutical companies worldwide.

Flexibility: At Invimeds, our comprehensive services extend to single and multiple batch sourcing, tailored to meet specific quantity and expiration requirements. We specialize in procuring biologics and storing them in our state-of-the-art warehouse facilities.

During storage, we meticulously maintain the optimal temperature conditions with the assistance of advanced data loggers, ensuring that the integrity of the products is preserved at all times. Our vigilant monitoring system operates 24/7 to guarantee that the biologics remain in pristine condition until they are ready to be shipped to our clients. With us, you can trust that your biologics are in safe hands, from procurement to delivery.

Timeliness: We understand the critical importance of delivering RLD and biologics at the right time. Timeliness is not just a goal, it’s our commitment to our clients. We prioritize efficient logistics and streamlined processes to ensure that every delivery meets or exceeds expectations.

Our dedicated team members work tirelessly to monitor every step of the delivery process, providing regular updates and maintaining clear communication with our clients. With us, you can trust that your shipments will arrive precisely when you need them, without any compromise on quality or reliability.

Collaboration Between Invimeds and Dongkook Pharmaceutical

Invimeds proudly announces its strategic partnership with Dongkook Pharmaceutical in South Korea. This collaboration marks a significant step forward in our journey to deliver high-quality pharmaceutical products to our valued clients. As a seasoned player in the field, Invimeds brings years of experience and a steadfast commitment to authenticity and reliability. By joining forces with Dongkook Pharmaceutical, a distinguished RLD supplier known for its unwavering adherence to stringent quality standards, we are further solidifying our position as a trusted provider in the industry.

Our partnership ensures that our clients receive pharmaceuticals of unmatched authenticity and efficacy, backed by rigorous quality assurance processes at every step. With our shared values and commitment to excellence, we are poised to elevate the standard of pharmaceutical sourcing and meet the diverse needs of our clients with confidence and integrity.

Conclusion:

Invimeds, as your trusted partner, procuring biologics and Reference Listed Drugs (RLDs) for the South Korean market becomes a seamless and reliable process. Our partnership with Dongkook Pharmaceutical in South Korea further strengthens our commitment to authenticity and reliability in pharmaceutical procurement. Leveraging this partnership, along with our expertise, streamlined processes, and unwavering commitment to quality and compliance, we ensure that your pharmaceutical procurement needs are met with excellence. By partnering with us, you gain access to a proven track record of reliability and integrity in the sourcing of pharmaceutical products.

Whether you require RLDs or biologics from South Korea, our comprehensive solutions and dedicated team are here to support you every step of the way. Trust in our process and expertise, backed by our partnership with Dongkook Pharmaceutical, to deliver exceptional results for your pharmaceutical procurement needs. Contact us now to embark on a journey marked by unmatched reliability and excellence.