More than 300 billion markets were divided into food, and the 31 biological similar drugs led the way and went on the market in line

Recently, the official website of the State Food and Drug Administration released that the first biological similar drug in China, rituximab injection (trade name: hanlikang), developed by Fuhong Hanlin, a subsidiary of Fosun Pharmaceutical, was approved for marketing, and the drug was approved for the treatment of non Hodgkin's lymphoma This is another milestone in the research and development history of domestic bio similar drugs since the State Food and Drug Administration (CFDA) officially promulgated the technical guidelines for research, development and evaluation of bio similar drugs (Trial) on February 8, 2015 Since then, the domestic market of self-produced biological similar drugs has begun to sprout Looking around the world, biological analogues have gradually gained more recognition It is reported that in 2018, the U.S FDA approved a total of 7 biological analogues, which is the total number of approved drugs in previous years With the expiration of more original research patents, the number of biological similar drugs will continue to increase, and with the price advantage, its scale will also show a high-speed growth trend According to the research report released by Southwest Securities, Frost & Sullivan predicted that from 2016 to 2021, the global growth rate of biological similar drugs will be 53.7% with a compound annual growth rate, and the sales volume will reach 36.6 billion US dollars in 2021 At present, only one drug, rituximab of Fuhong Hanlin, has been approved in China, and the market of similar biological drugs is still a blue ocean According to the application of biological similar drugs in China, many enterprises, such as Xinda biology, Zhejiang Haizheng, Jiahe biology, Fuhong Hanlin, etc., are obviously aware of this Up to now, more than 200 clinical trials of biological analogues have been approved in China, which occupies a leading position in the world According to the statistics of drug intelligence data, among the more than 200 approved clinical records, the biological analogues with the largest number of clinical approval and the largest number of clinical three-phase drugs include adalimumab, trastuzumab, bevacizumab, rituximab and infliximab In addition, the top four drugs in the five varieties are the top 10 in global drug sales The sales of the five drugs in 2018 have reached 45.993 billion US dollars, about 307.652 billion yuan In addition to the approval of rituximab injection of Fuhong Hanlin, 6 of the 5 approved clinical biological analogues have submitted listing applications and been accepted, and 24 have entered phase 3 clinical trials These 31 biological similar drugs will also become the first batch of troops with market sales of more than 300 billion yuan 1 The original manufacturer of adalimumab: EBV trade name: Humira (sumil) global sales volume in 2018: 19.936 billion US dollars indications: rheumatoid arthritis, ankylosing spondylitis and other autoimmune diseases adalimumab is a tumor necrosis factor (TNF) antagonist, through specific combination with TNF - α, to prevent TNF - α from activating p55 and TNF receptor on the surface of p75 cells After being approved by FDA on December 31, 2002, it was listed in Europe and Japan successively, and it was approved by CFDA on February 26, 2010, and listed in China In 2018, global sales reached US $19.936 billion, an increase of 8% over 2017 As the drug with the highest sales volume in the world, adamumumab biological similar drug has also been sought after by many domestic enterprises, with nearly 30 enterprises applying for it Among them, rhTNFR: FC and ubp1211 of Qilu pharmaceutical and Jiangsu Zhonghe pharmaceutical have also entered three phases of clinical practice The former has been declared as ankylosing spondylitis and the latter as moderate to severe active rheumatoid arthritis The application for listing of related drugs of four enterprises, namely, baiaotai, Haizheng pharmaceutical, Xinda biology and Fuhong Hanlin, has been accepted, and the first three enterprises have been included in the priority review The listing is imminent, and the completion time is expected to be in October 2019 Adalimumab biological analogues enter clinical phase 3 / application details 2 Trastuzumab single antigen manufacturer: Roche trade name: Herceptin (Herceptin) global sales in 2018: 7.032 billion USD indications: treatment of breast cancer with HER2 overexpression, metastatic gastric cancer with HER2 overexpression or adenocarcinoma at the esophageal gastric junction Trastuzumab is a HER2 receptor antagonist, which binds to HER2 on tumor cells and mediates antibody dependent cytotoxicity (ADCC) The drug was approved by FDA on September 25, 1998 and CFDA on September 5, 2002 Global sales in 2018 were $7.032 billion, down 4% from 2017 There are more than 10 domestic enterprises applying for the biological similar drugs, among which Fuhong Hanlin, Jiahe biology and Haizheng pharmaceutical have entered the stage 3 clinical stage, and the indications are breast cancer The fastest is Sansheng Guojian, whose listing application has been accepted by the State Administration of pharmaceutical supervision on September 10, 2018, and has been included in the priority review It is expected that the approval will be completed in October 2019 Trastuzumab biological analogues enter clinical phase 3 / details of application for listing 3 Original manufacturer of bevacizumab: Roche trade name: Avastin (avidin) global sales in 2018: US $6.898 billion indications: colorectal cancer, lung cancer, etc Bevacizumab is a vascular endothelial growth factor (VEGF) inhibitor, which can specifically bind to VEGF, thus blocking the binding of VEGF and its receptors (flt-1 and KDR) on the surface of endothelial cells, so as to inhibit tumor angiogenesis The drug was approved by FDA on February 26, 2004 and CFDA on February 26, 2010 Global sales in 2018 were $6.898 billion, down from $6.99 billion in 2017 Bevacizumab is another popular monoclonal antibody after adamuzumab At present, there are more than 20 domestic enterprises applying for it, and the drug is also the most variety in the third phase of clinical enterprises, reaching 11, with fierce competition Only the listing application of Xinda bio ibi305 was accepted on January 31, 2019, and it is expected to be approved in December 2019 Bevacizumab biological analogues enter clinical phase 3 / application details 4 The original manufacturer of rituximab: Roche trade name: rituxan (rituximab) global sales in 2018: US $6.801 billion indications: non Hodgkin lymphoma, rheumatoid arthritis, etc Rituximab is a kind of monoclonal antibody targeting at CD20 It combines with CD20 antigen expressed on the surface of B lymphocyte and kills tumor B cell through complement dependent cytotoxicity (CDC) and antibody dependent cytotoxicity (ADCC) The drug was approved by FDA on November 26, 1997 and CFDA on April 21, 2008 Global sales in 2018 were $6.801 billion, down 12% from 2017 More than 15 domestic enterprises have applied for letuximab biological analogues, among which the indications of non Hodgkin's lymphoma (diffuse large B-cell lymphoma) applied by Fuhong Hanlin needle have taken the lead, and have been approved for listing in the first place Five enterprises, including Zhengda Tianqing, Haizheng pharmaceutical and Cinda biology, have entered into three stages of adaptation In addition, another indication of rheumatoid arthritis declared by Fuhong Hanlin has entered clinical stage 3 Letuximab biological analogues enter clinical phase 3 / details of application for Listing 5 Original manufacturer of infliximab: Johnson & Johnson trade name: REMICADE (Lek) global sales in 2018: 5.326 billion USD indications: rheumatoid arthritis, ankylosing spondylitis, psoriasis arthritis, etc Infliximab is a tumor necrosis factor (TNF) blocker It binds to soluble and transmembrane TNF α with high affinity and inhibits the binding of TNF α to its receptor It was approved by FDA on August 24, 1998, and then approved by CFDA on May 17, 2007 In 2018, its global sales volume was US $5.326 billion, down 16% compared with 2017 Compared with the top four drugs, it was the most declined one In addition, compared with the first four drugs, there are relatively few companies applying for the biological analogues of infliximab However, as long as the companies applying for the drugs have almost entered the clinical phase 3, including Jiahe biology, bemebo and Haizheng pharmaceutical The first two indications were rheumatoid arthritis and the last one was plaque psoriasis Infliximab biological analogues entering clinical phase 3 / details of application for listing