Sun Pharma obtained FDA approval for its biologics drug

| By | FDA, Generics, Sun Pharma
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Sun Pharma, the world’s fifth largest specialty generic pharmaceutical company and India’s top pharmaceutical company, announced that the U.S. FDA has approved its biologics drug Ilumya (Tildrakizumab) for the treatment of adults with moderate-to-severe plaque psoriasis.

Sun Pharma has acquired rights for Tildrakizumab from US drug maker Merck in 2014. While Merck was responsible for the clinical studies, Sun Pharma was responsible for all the other regulatory activities manufacturing and commercialization of the product. The regulatory approval clears all regulatory hurdles in commercializing this novel biologic drug.

Sun Pharma has also signed a licensing agreement with Almirall S.A. in July 2016 for development and commercialization of Tildrakizumab in Europe. Almirall is expecting to introduce Tildrakizumab, first biologic for psoriasis, in Europe in the 2019.

Sun Pharmaceutical Industries has also entered into a long-term manufacturing agreement with South Korea’s Samsung Biologics for Tildrakizumab. The value of the contract is $55.5 million.

SOURCE: sun pharma
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