AbbVie Humira biosimilars are expected to be approved

fda's advisory panel unanimously voted unanimously to approve Aer Avivh Humira biosimilars developed by Amjin. If successfully approved, Amsin Biosimilars will join a new range of biosimilars. These biosimilars are expected to save U.S. insurers, doctors and patients billions of dollars.
Humira is used to treat rheumatoid arthritis and other inflammatory diseases, and last year sales of the drug were close to $15 billion, according to Ames Medical. The advisory panel's recommendations will pave the way for the FDA to formally approve the biosimilar.
years, there has been no competitive pressure on the original biopharmaceuticals, because even when patents expire, there is no regulatory pathway to approve biosimilars. If successfully approved, Amsin Biosimilars will join a new range of biosimilars. These biosimilars are expected to save U.S. insurers, doctors and patients billions of dollars.
, an analyst at Evercore ISI, predicts that Amgen could launch the biosimilar as early as March 2017, but could be at risk of patent infringement. AbbVie claims Humira's patents will not expire until at least 2022. Wall Street analysts expect the patent dispute between the two companies to be resolved in court, after which Amjin is expected to launch the drug between 2018 and 2022.
first approved in 2002 and has been one of the world's most lucrative drugs. It accounted for 60 per cent of AbbVie's total revenue last year. The injectable drug, which blocks inflammation-related chemicals, has been approved to treat rheumatoid arthritis, Crohn's disease and psoriasis.
is seeking FDA approval to use the biosimilar abP501 it develops to treat eight diseases. Amjin itself is a large biotech company, and its drugs have been hit by cheaper generics. The company is hedging losses by developing generic versions of rival drugs.
are injectables made from living cells and are powerful and often more expensive than traditional chemicals. Six of the world's top 10 best-selling drugs in 2015 were biologics, with sales totaling more than $56 billion.
the FDA only last year approved the first biosimilar, the Axon Neupogen generic developed by Novarlor. In April, Pfizer's Johnson and Johnson Remicade generics were approved for sale, becoming the second approved biosimilar.
question is how much money American biosimilars can help save. Novaral Zarxio is 15% less expensive than Neupogen, the original drug. Experts expect a price discount rate of between 15 and 30 percent for biosimilars in the United States. In Europe, when prices are regulated by the government, the discount rate is even greater.
U.S. spending on original drugs has doubled to $150 billion since 2010, according to Ames Healthcare. Developing lower-priced drugs is critical to reducing U.S. drug spending. (China Pharmaceutical News Network)