FDA approval of the second Humira analogue

Source: the second Humira (adalimumab-adbm, 40 mg / 0.8 ml) generic drug was approved by FDA on August 25, 2017 Approved indications include adult moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderate to severe active Crohn's disease and ulcerative enteritis, moderate to severe plaque psoriasis, and polyarticular juvenile idiopathic arthritis in adolescents over 4 years old Humira is the first anti TNF - α drug on the market in the world Since it was first approved by FDA in 2002, it has generated nearly $100 billion in sales revenue Until now, it has also refreshed the annual sales record of a single drug with a double-digit annual growth rate The global sales volume of Humira in 2016 is US $16.078 billion, and the sales volume in the first half of this year is US $8.834 billion, which is expected to reach US $18 billion in 2017 Amjevita (adalimumab Atto) of amjin is the first Humira generic drug approved by FDA, which was approved as early as September 23, 2016 However, amjevita is still not listed in the United States because the patent lawsuit between abbvie and amjin has not been resolved In early August, Boehringer Ingelheim was also sued by abbvie, who was accused of violating 74 patents of Humira Therefore, Boehringer Ingelheim should not be listed for sale of cyltezo in the near future Protected by more than 100 patents, Humira has not been impacted by biological analogues, and its sales in the U.S market in the first half of this year have not been affected at all, with an increase of 20% (US $5.897 billion) Abbvie is even confident that its patent protection will last until 2022 But with the impact of generic companies and a significant increase in the number of lawsuits, the pressure on abbvie and the U.S patent and Trademark Office will increase Andrew Baum, an analyst at Citibank, said: "adamumumab analogues will go on the market faster than abbvie expected Humira's sales are expected to peak in 2018, and then start to decline In 2022, it will drop to about $6 billion.".