How many games can xiumeile win in the "King's glory"?

In the list of global top 10 drug sales in 2017, Humira (adamumumab) Co., Ltd of abbvie won the title with us $18.427 billion, which is the sixth consecutive year that Humira has won the title of "drug king" since taking over from boliwei in 2012 (see: 2017 global drug sales data Xlsx) EBV Humira's sales over the years (million US dollars) source: the sales volume of medicine cube database is 100 billion Adamumumab is the first all-human anti TNF - α drug to be listed in the world in the past life It started from the joint research of BASF knoll, a subsidiary of BASF, and Cambridge antibody Technology (CAT) in 1993 Cambridge antibody technology uses TNF α as antigen and their unique phage display technology to obtain all human antibody d2e7 in vitro In the subsequent study, BASF Knoll further improved the whole human antibody d2e7, and completed the early production process development and clinical application In June 2002, Abbott acquired BASF Knoll with us $6.9 billion, and obtained the right of development, production and sales of all human antibody d2e7 Finally, it put adamumumab on the market On January 2, 2013, Abbott separated Albuquerque independently for the development needs, and Albuquerque was responsible for the production, development and sales of adalimumab in the later stage Prior to that, Abbott also reached an agreement with Eisai, a Japanese pharmaceutical company, to grant market rights of adalimumab in Japan, South Korea and Taiwan for the treatment of rheumatoid arthritis to Eisai Adalimumab entered the Japanese market in 2009, and in March this year, it was approved as the 10th indication for the treatment of patients with pustular psoriasis who were not relieved by conventional treatment Since it was first approved by FDA in 2002, adalimumab has generated a total sales revenue of US $116.1 billion In 2017, the growth rate of the U.S market was 18.5% and that of the global market was 14.6% Therefore, until now, the annual sales record of single drug has been refreshed with a double-digit growth rate every year Up to now, 14 indications of adalimumab have been approved in the world, according to ebervey In China, adamumumab has been approved for three indications: rheumatoid arthritis in 2010, ankylosing spondylitis in 2013 and plaque psoriasis in 2017 When the patent expires, the core patent challenging the original adamumumab research has expired in the United States in 2016, and the patent in Europe will also expire this year In order to prevent other bio generic pharmaceutical enterprises from occupying the market after the expiration of adalimumab patent, Alberta has applied for dozens of patents, whose expiration time will be between 2022 and 2034 In particular, it has applied for two patents for injection methods of indications such as rheumatoid arthritis and psoriasis, and extended the patent time to 2022 and 2023 respectively However, this approach has not been effective in India As early as 2014, India's generic drugmaker cadilla healthcare announced the launch of exemptia, the world's first biological analogue of adamumumab, in India Adalimumab sold for $1000 per bottle in the United States, while Cadila set the price of exemptia in the Indian market as one fifth of the original research price (i.e 200 dollars per bottle) Samsung biopis, a biopharmaceutical company owned by Samsung, once filed a patent invalidation lawsuit with its European commercial partner Biogen On March 3, 2017, the British court ruled that there was no patentability in the relevant patent application of Aberdeen However, just last week (April 5), Aberdeen announced a global settlement with Samsung bioepis on patent infringement lawsuit of adamuzumab biological similar drugs (see: abbvie and Samsung bioepis patent lawsuit reach a settlement!) Aberdeen will grant Samsung bioepis a non exclusive license for the patent rights it holds According to the agreement, in the U.S market, the patent license obtained by Samsung bioepis from Aberdeen will take effect from June 30, 2023, while in most EU countries, the license will take effect from October 16, 2018 Imraldi, an adalimumab like drug from Biogen / Samsung bioepis, has been approved by the European Union in August 2017, but has not yet been approved in the United States Biogen / Samsung bioepis will pay the future sales share of the products to Aberdeen according to the agreement Amjevita (adalimumab Atto) of Amgen is the first FDA approved biological analogue of adalimumab, which was approved as early as September 23, 2016 But Aberdeen sued Amgen in August 2016 (one month after the FDA advisory committee), accusing it of violating 51 patents declared by Humira, and asking the court to ban amjevita from listing As patent litigation is pending, Amgen has not ventured to sell amjevita in the US market On September 28, 2017, ebervey and Amgen reached a settlement on patent infringement lawsuit of adalimumab biological similar drugs Abwi granted amjevita (adalimumab Atto) non exclusive patent license to amjin, which took effect in the U.S market on January 31, 2023 and in most countries of the European Union on October 16, 2018 In July 2017, the patent trial and appeal board of the U.S patent and Trademark Office made a decision to support the five "135 patent" challenges proposed by blinger Ingelheim (BI) against oberway's heavyweight product sumerial after multiple IPR reviews On August 25 of the same year, the FDA approved the launch of the second biomimetic drug of sumerial, namely the cyltezo (adalimumab adbm, 40 mg / 0.8 ml) of bringer Ingelheim 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 On January 16 this year, Sandoz, a generic business unit of Novartis pharmaceutical, also announced that FDA accepted the biological product license application (BLA) of its adalimumab biological similar drugs, and the application documents were conducted according to the 351 (k) path Who will take the title of domestic medicine? To a great extent, adamumumab's overseas sales benefit from perfect commercial insurance system and high price advertising Compared with the global market, the sales of adamumumab in China is not ideal, which may be related to the domestic medical consumption level The recombinant human type II tumor necrosis factor receptor antibody fusion protein and infliximab, which are the main competition varieties of adamumumab in China, have entered the new version of national medical insurance As early as December 28, 2010, adamumumab's net price in Henan Province was 7820 yuan (40mg / 0.8ml), the highest bidding price was 10270.00 yuan (40mg / 0.8ml), and the lowest bidding price was 7600 yuan (40mg / 0.8ml) In the medical insurance negotiation in July 2017, adamumumab failed to enter the negotiation list, which really surprised the industry Even in Jiangsu Province, a large province with relatively developed economy, adamumumab has not been included in the catalogue of drugs for basic medical insurance, work injury insurance and maternity insurance of Jiangsu Province (2018 version) published a few days ago (April 8) However, in Qingdao, adamumumab has been officially included in the list of serious illness insurance in Qingdao since 2015; in Shenzhen supplementary medical insurance for serious and serious diseases, patients with ankylosing spondylitis pay 20 yuan a year for insurance, and the drug can be reimbursed 70%; in addition, adamumumab was also included in the payment scope of serious illness insurance in Zhejiang Province at the beginning of this year The imitation of Adamu monoclonal antibody has already begun in China According to statistics, there are more than 10 imitation manufacturers of adamumumab in China, among which two tests of baiaotai and Xinda have been carried out to clinical stage III When will they abdicate? Andrew Baum, an analyst with Citibank, said: "the time to market of a variety of biological analogues of adalimumab is faster than that expected by eberway The sales volume of adalimumab is expected to peak in 2018, and then start to decline In 2022, it will drop to about 6 billion dollars." In a report, UBS analyst Marc Goodman revealed to investors that Aberdeen is still optimistic about the market performance of adalimumab, especially in the overseas market "Before the market share of similar biological drugs is greatly eroded, Humira will take the lead in reaching the peak sales in the overseas market in 2018." Eric Gonzalez, CEO of Aberdeen, once said at JPMorgan in 2016 that he would set the peak value of Humira sales to hit $18 billion in 2020 Fortunately, this goal was achieved ahead of schedule in 2017 E valuate Pharma released the report "world preview 2017, outlook to 2022" last year, which predicted that in 2020, Humira will be the "king of medicine" with the sales volume of $15.901 billion, and the sales volume in 2022 will still reach more than $13.6 billion The report of the mega blockbusters – biologicals dominate biopharma's Hall of fame, which is also a part of E value's EP vantage, also predicted that by 2022, the cumulative global sales of Humira would reach US $223.7 billion, and that of 2018-2022 would reach US $107.6 billion.