Tedizolid Phosphate

Dong-A ST’s biologics license application (BLA) for Imuldosa, submitted in October 2023, is approved by the U.S. Food and Drug Administration SEOUL, South Korea--(BUSINESS WIRE)-- #BLA -- Dong-A ST (President/CEO Jae-Hun Jung, KRX: 170900) announced on October 11 that Imuldosa™ (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara®, has won U.S. Food and Drug Administration (FDA) approval. As its second FDA-approved biosimilar after Sivextro® (tedizolid phosphate) in 2014, the company has once again demonstrated its R&D competence. The news comes following the FDA acceptance of the biologics license application (BLA) submitted by Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, in October 2023. Imuldosa is a biosimilar to Stelara, a blockbuster drug developed by Janssen Biotech Inc. for the treatment of patients with autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. It is one of the highest-grossing biopharmaceuticals generating US$10.86 billion globally (IQVIA Accumulative Sales in 2023). Dong-A Socio Holdings and Meiji Seika Pharma began joint development for Imuldosa in 2013, and the rights for R&D and commercialization were transferred from Dong-A Socio Holdings to Dong-A ST in July 2020 for efficient project management. In July 2021, Dong-A ST and Meiji Seika Pharma signed a global license agreement with Intas Pharmaceuticals, who is set to commercialize the biosimilar with its global subsidiaries including Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada. Accord Healthcare has also submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) in June 2023, which was accepted in the following month of July 2023. Dr. Jae-Hong Park, the Head of R&D at Dong-A ST commented, “This FDA approval indicates global recognition of Dong-A ST’s R&D excellence and global competitiveness. We look forward to a successful launch of Imuldosa in the U.S., the world’s largest pharmaceutical market, as we continue to develop innovative medicines to further strengthen our global presence.” Contacts Dong-A ST CO., Ltd Shin-Hee Park +82-32-610-2481 sh-park@donga.co.kr

Sun Pharmaceutical Industries has released Tedizolid Phosphate tablets 200 mg in India under the brand name 'STARIZO'. STARIZO (Tedizolid Phosphate) is a novel, oxazolidinone-class antibacterial, used to treat Acute Bacterial Skin and Skin Structure Infection (ABSSSI). Sun Pharma has obtained rights from MSD to develop, manufacture and commercialise Tedizolid Phosphate in India. “Drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) causing ABSSSIs, are more challenging to treat due to the limited availability of effective treatment options in hospitals. With STARIZO, we are introducing a treatment option which is effective and has the convenience of once-a-day dosing. At Sun Pharma, it has always been our endeavour to introduce innovative medicines that help improve the quality of life of patient,” said Kirti Ganorkar, CEO- India Business, Sun Pharma. Skin and soft tissue infections are the most common type of infections constituting, around 29–32 percent of all infections in 2018-2019 in India. The treatment of ABSSSI is further complicated with associated comorbidities such as diabetes, obesity, renal and hepatic dysfunction in these patients. The incidence of invasive S. aureus infections has increased over the past decades and is associated with poor outcomes and high mortality rates. S. aureus is responsible for almost one-third of ABSSSIs, with MRSA accounting for a large proportion of these. MRSA rates in India have been increasing each year, from 28.4 percent in 2016 to 42.6 percent in 2021 (S. aureus infections). Drug-resistant bacteria, such as MRSA causing ABSSSIs, are more challenging to treat due to the limited availability of effective antibiotics. STARIZO (Tedizolid Phosphate) is a once-a-day oral treatment for six days compared to the current standard of care which has to be given twice daily for 10-14 days. STARIZO (Tedizolid Phosphate) has demonstrated activity against gram-positive organisms, including MRSA. STARIZO (Tedizolid) provides the advantage of reduced frequency and duration of drug administration. STARIZO (Tedizolid Phosphate) requires no dose adjustment in the elderly, patients with hepatic or renal impairment, and patients on haemodialysis.