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In the 2017 global Top10 drug sales list, AbbVie’s Humira (adamumab) won the laurel for $18 billion 427 million, which was the sixth consecutive year of the global “drug king” after the 2012 baton of Brady.

One hundred billion sales, past and present

Adalimumab is the world’s first commercially available fully humanized anti-TNF-α drug, starting in 1993 with the joint effort of BASF Knoll, a BASF subsidiary, and Cambridge Antibody Technology (CAT).

The Cambridge antibody technology uses TNFα as antigen to obtain the fully human antibody D2E7 in in vitro screening using their unique phage display technology. In the subsequent study, BASF Knoll further improved the whole human antibody D2E7, and completed the previous production process development and clinical reporting.

In June 2002, Abbott Pharmaceuticals (Abbott) acquired BASF Knoll for $6.9 billion and obtained the right to develop, manufacture and market the fully human antibody D2E7, which finally brought Adalimumab to the market.

On January 2, 2013, Abbott separated Abbott’s independence due to development needs, and Eberviè was responsible for the later development, production, and sales of adalimumab. Prior to this, Abbott Laboratories also reached an agreement with Japanese pharmaceutical company Eisai to award the market rights of Adalimumab for rheumatoid arthritis in Japan, Korea, and Taiwan to Eisai.

Admiralumab entered the Japanese market in 2009. In March this year, it has been approved for the tenth indication for the treatment of patients with pustular psoriasis that are not adequately treated by conventional treatments.

Since it was first approved by the FDA in 2002, Adalimumab has accumulated sales of 116.1 billion U.S. dollars. Its growth rate in the U.S. market in 2017 was 18.5%, and its global market growth rate was 14.6%. A two-digit increase refreshes the annual sales record for a single drug. Abbey said that as of now, Adalimumab has been approved in 14 indications worldwide.

In China, adalimumab has been approved for three indications: approval of rheumatoid arthritis indications in 2010, approval of ankylosing spondylitis indication in 2013, and approval of moderate-severe plaque psoriasis in 2017 disease.

Patent expires

The core patent of adalimumab has expired in the United States in 2016, and patents in Europe will also expire this year. In order to prevent other biosimilar companies from seizing the market after the patent of Adalimumab expires, Ebervière has applied for dozens of patents. Its expiration time will be between 2022 and 2034, especially for rheumatoid arthritis and Indication methods such as psoriasis applied for two patents and extended the patent time to 2022 and 2023, respectively.

However, this practice was not effective in India. As early as 2014, Indian generic drug manufacturer Cadila Healthcare announced the launch of the world’s first biosimilar drug, Ademptia, of adalimumab in India. At the time, Adalimumab was sold in the US for US$1,000 per bottle, while Cadila set the price of Exemptia in the Indian market as one-fifth of the original research (ie, US$200 per bottle).

Samsung’s biopharmaceutical company, Samsung Bioepis, has filed a patent invalidation suit with its European commercialization partner Biogen. On March 3, 2017, the English courts issued a judgment saying that Abbey related patent applications do not have patentability. However, just last week (April 5th), Ebervier announced that it had reached a global settlement with Samsung Bioepis on the patent infringement lawsuit of biological analogs of adalimumab.

Abbey will grant Samsung Bioepis a non-exclusive license for its patent rights. According to the agreement, in the US market, the patent license granted by Samsung Bioepis from AbbVe came into effect on June 30, 2023. In most EU countries, the license will take effect on October 16, 2018. Imraldi, a similar drug to adalimumab from Biogen/Samsung Bioepis, was approved by the European Union in August 2017 but has not yet been approved in the United States. Biogen/Samsung Bioepis will pay Abevi for future sales of product sales in accordance with the agreement.

Amgen’s Amjevita (adalimumab-atto) is the first FDA-approved biological analog of adalimumab, which was approved as early as September 23, 2016. But Ebwell sued Amjin in August 2016 (one month after the FDA advisory committee), alleging that he infringed on 51 patents that Humira had stated and asked the court to ban Amjevita from listing. Due to the pending patent litigation, Amgen did not dare to risk selling Amjevita in the US market.

On September 28, 2017, Ebervif and Amgen reached a settlement on a patent infringement suit against biological analogs of adalimumab. Abbey grants Amgen’s non-exclusive patent license for Amjevita (adalimumab-atto), which took effect on the US market from January 31, 2023 and in most EU countries since October 16, 2018.

In July 2017, the Patent and Trademark Office’s Patent Trial and Appeals Committee reviewed the five “135 patents filed by Boehringer Ingelheim (BI) for Ebervey’s heavyweight repair product Merrill after undergoing multiple intellectual property reviews. “Challenge, made a decision to support. On August 25th of the same year, the FDA approved the launch of the second biosimilar drug from Humira, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm, 40 mg/0.8 mL). Approved indications include moderate to severe active rheumatoid arthritis in adults, active psoriatic arthritis, active ankylosing spondylitis, moderate-to-severe active Crohn’s disease and ulcerative colitis, and moderate-to-severe plaque psoriasis Diseases and polyarticular juvenile idiopathic arthritis in adolescents over the age of 4 years.

On January 16th this year, Sandoz (Santex), a generic pharmaceutical business unit of Novartis Pharmaceuticals, also announced that FDA has accepted its biological product (BLA) for biological analogs of adalimumab. The application documents follow the 351 (k) path. get on.

Chinese market

The bright performance of overseas sales of adalimumab is largely due to a well-developed commercial insurance system and sky-high advertising. Compared with the global market, sales of Adalimumab in China are not satisfactory, which may be related to the level of medical consumption in China. The main competitive species of adalimumab in China, recombinant human type II tumor necrosis factor receptor-antibody fusion protein, infliximab has entered a new version of China National Medical Insurance.

Adalimumab early as December 28, 2010 in Henan Province of China net price is 7820 yuan (40mg / 0.8ml), the highest bid price was 10,270.00 yuan (40mg / 0.8ml), the minimum bid price is 7600 yuan ( 40mg / 0.8ml). In the health care negotiations in July 2017, Adalimumab failed to enter the negotiating directory, which actually made the industry feel a bit surprised.

Even in the more economically developed provinces such as Jiangsu, China, in the “Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalogue (2018 Edition) of Jiangsu Province, published in the previous few days (April 8th), Monoclonal antibody incorporation.

However, in Qingdao, China, adalimumab was officially included in the list of medical insurance for major diseases in Qingdao since 2015; in Shenzhen, a special disease supplement medical insurance, patients with ankylosing spondylitis pay 20 yuan per year, and the drug can be reimbursed. 70%; In addition, adalimumab was also included in Zhejiang Province’s major illness insurance coverage at the beginning of this year.

The imitation of adalimumab in China has already begun. According to statistics, there are more than 10 imitation manufacturers of adalimumab in China, of which Biotec and Cinda have conducted clinical trials in phase III.

Champion throne, when will give way?

Citibank analyst Andrew Baum said: “A variety of adalimumab biosimilars are on the market sooner than Ebway predicted. Sales of adalimumab are expected to peak in 2018 and then begin to decline, by 2022. It will drop to about 6 billion U.S. dollars.”

UBS analyst Marc Goodman revealed to investors in a report that Ebervi was optimistic about the market performance of Adalimumab, especially in overseas markets. “Humira will In 2018, it took the lead in sales in overseas markets.”

AbbVe CEO Rick Gonzalez once told JP Morgan in 2016 that Humira’s sales peak was set to hit $18 billion in 2020. Fortunately, this goal has been achieved ahead of schedule in 2017.

Evaluate Pharma released the report “World Preview 2017, Outlook to 2022” last year and forecasts that in 2020, Humira will be seated in the “drug king” position with sales of US$15.901 billion, and sales in 2022 will still reach more than US$13.6 billion.

The “mega-blockbusters – biologicals dominate biopharma’s hall of fame” report recently released by Evaluate’s EP Vantage also predicts that by the year 2022, Humira’s global cumulative sales will reach US$223.7 billion, accumulating over the period 2018-2022. Sales will reach 107.6 billion U.S. dollars.

The last question is, how many years do you think Humira will lead in this “King glory” competition?

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