Biocon Pharma gets USFDA nod for arthritis drug Tofacitinib ER
Bengaluru: Biocon has announced that Biocon Pharma Limited, a wholly owned subsidiary of the Company, has received approval from the U.S Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Tofacitinib Extended- Release Tablets. The company has secured final approval for 11mg strength and tentative approval for 22mg strength.
Read also: Biocon expects 50 percent drop in costs for developing complex biosimilars: Top executive
In May, Biocon Biologics received marketing authorisations in the United Kingdom for YESINTEK, a biosimilar of Ustekinumab from the Medicines and Healthcare products Regulatory Agency (MHRA). YESINTEK is indicated for the treatment of adults and children from the age of 6 years and older with moderate to severe plaque psoriasis, and adults with active psoriatic arthritis or moderately to severely active Crohn’s disease.
Read also: Biocon arm gets marketing nod in UK for plaque psoriasis drug Yesintek
In February, European Commission granted marketing authorisation to Yesintek.
Biocon Limited, publicly listed in 2004, is a global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.
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