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22 Oct 2024
Admin
News Article

EMA’s Human Medicines Committee Recommends Marketing Approval for Imuldosa

EMA’s human medicines committee recommends marketing approval for Accord Healthcare’s Imuldosa, a ustekinumab biosimilar to Stelara

Overview

Accord Healthcare Limited (Accord), a wholly owned subsidiary of Intas Pharmaceuticals, is a leading generic pharmaceutical company, announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Imuldosa (development code: DMB-3115), a biosimilar of Stelara (ustekinumab), marketed by Janssen Biotech Inc., a subsidiary of Johnson & Johnson.

About Ustekinumab

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which may play an important role in inflammatory and immune responses.

Statement from the EVP: Accord Healthcare

Paul Tredwell, executive vice president of Accord Healthcare, said, ""We are delighted with the positive CHMP opinion for Imuldosa. This further strengthens our established autoimmune franchise, where Accord already has several leading speciality brands. The recommendation affirms Accord's continued strategy to expand its speciality business with an industry-leading portfolio, this positive opinion, combined with a further 10 biosimilars in development, reaffirms our commitment to improve access to value-based medicines for patients.""

Words form the MD: Intas Pharmaceuticals Ltd.

"We are truly excited by this partnership which, besides strengthening our existing biosimilar portfolio, also reinforces our long-term commitment towards bettering access to medicines for patients globally," said Binish Chudgar, executive chairman and managing director of Intas Pharmaceuticals Ltd.

Stelara: Indication

Stelara is indicated for a range of immunology indications and has recorded global sales of US$ 19 billion of which US$ 3.2 billion sales coming from Europe as per IQVIA MAT June 2024 data.

The Accord Healthcare

Accord Healthcare, a wholly owned subsidiary of Intas Pharmaceuticals, is a leading generic pharmaceutical company.
Accord is committed to improving lives by increasing access to medicines while also providing novel solutions that enhance the pharmaceutical experience for both healthcare providers and patients.

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