Humira is the world's top-selling drug, with sales of $20 billion
last year, but now faces competition from cheaper versions in Europe
and a 2023 expiration of its patents in the United States, by far
the most profitable market.
The National Medical Products Administration (NMPA), in a statement
on its website on Thursday, said Bio-Thera's Qletli "was highly
similar to the approved reference drug in terms of quality, safety
The drug has been approved for the treatment of three autoimmune
diseases, including rheumatoid arthritis, ankylosing spondylitis,
and plaque psoriasis, Bio-Thera said in separate a statement
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"The NMPA approval of Qletli is a very important milestone for our
biosimilar portfolio, providing an new affordable treatment option
for patients in China with several types of autoimmune diseases,"
Bio-Thera CEO Shengfeng Li said.
(Reporting by Roxanne Liu in Beijing and Shubham Kalia in Bengaluru;
editing by Uttaresh.V)
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