Dong-A ST's IMULDOSA: Pioneering Stelara Biosimilar Success
Dong-A ST Celebrates a Major Milestone with IMULDOSA
Dong-A ST has recently secured a significant achievement by obtaining marketing authorization from the European Commission for its biosimilar, IMULDOSA. This product is a biosimilar referencing Stelara, a well-known biologic from Janssen Pharmaceuticals. The approval marks an exciting development in the treatment landscape for various inflammatory diseases.
Overview of IMULDOSA's Journey
The journey of IMULDOSA began in 2013, originating as a collaborative project between Dong-A Socio Holdings and Meiji Seika Pharma. Following a strategic decision, the commercialization and development rights were transferred to Dong-A ST in 2020, allowing the company to hone its focus on bringing this promising therapy to the market efficiently.
Collaboration and Development
Since the handover, Dong-A ST has established a fruitful partnership with Meiji Seika Pharma, continuously optimizing the formulation and conducting necessary trials to meet regulatory standards. Their combined expertise is instrumental in ensuring that IMULDOSA meets the safety and efficacy profiles required for approval.
First Steps into the European Market
The recent approval from the European Commission comes shortly after a positive recommendation from the Committee for Medicinal Products for Human Use under the European Medicines Agency. IMULDOSA’s entry into the European market signifies its potential to offer effective treatment options for patients suffering from inflammatory diseases such as plaque psoriasis, psoriatic arthritis, and Crohn's disease.
Significance of Stelara in the Market
Stelara, with its active ingredient ustekinumab, has generated substantial revenue, reporting global sales of $20.323 billion in 2023 alone. This highlights the remarkable demand for treatments targeting inflammatory conditions and underscores the significance of IMULDOSA in the therapeutic landscape.
Global Licensing Agreements
Dong-A ST’s strategic move to form a global out-licensing agreement with Intas Pharmaceuticals enhances the reach of IMULDOSA. Intas, along with its subsidiaries such as Accord Biopharma and Accord Healthcare, is positioned to launch the biosimilar in various regions, including Europe, Canada, and the United States. This partnership stands to accelerate the distribution of IMULDOSA to a vast patient population.
Future Outlook for IMULDOSA
The CEO of Dong-A ST expressed confidence in the product's prospects, noting that the approvals in both the United States and Europe are crucial steps toward establishing IMULDOSA within the global pharmaceutical market. The commitment to ensure that IMULDOSA becomes a reliable treatment option for patients worldwide remains a top priority.
Frequently Asked Questions
What is IMULDOSA?
IMULDOSA is a biosimilar medication developed by Dong-A ST, referencing the biologic Stelara, aimed at treating inflammatory diseases.
When was IMULDOSA approved in Europe?
IMULDOSA received marketing authorization from the European Commission, marking its entry into the European market.
What diseases does IMULDOSA target?
IMULDOSA is indicated for treating inflammatory diseases such as plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
Who developed IMULDOSA?
IMULDOSA was developed through a collaboration between Dong-A Socio Holdings and Meiji Seika Pharma, later managed by Dong-A ST.
What are the next steps for IMULDOSA?
Following approvals, IMULDOSA will be launched in multiple regions through partnerships with companies like Intas Pharmaceuticals.
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