Avastin: Roche vs Amgen, spear and shield

On February 20, 2017 local time, Genentech, a subsidiary of pharmaceutical giant Roche, sued Amgen Inc in the U.S court, claiming that the latter had hidden relevant information that may cause patent litigation in the application materials of biosimilar, which imitated Genentech's Avastin, so it was not in conformity with the biological product price competition and innovation act (hereinafter referred to as "the law") "Bpcia") Genentech cited historical data in its litigation materials, saying that the same reason was used when Amgen sued hospita in order to protect its own market of biological products, eoetinalfa Genentech's lawsuit against Amgen can be said to be "spear of Amgen, shield of Amgen" Avastin (commonly known as bevacizumab, bevacizumab) is a heavy-duty anti-tumor product of Genentech company Since it was approved by FDA in February 2004, its indications have covered colon cancer, breast cancer, lung cancer, kidney cancer, brain cancer and ovarian cancer In 2016, Avastin's total sales volume was about US $6.8 billion, which was coveted for its high profits and exclusive market power Amgen took the lead in the attack on Avastin market In November 2016, Amgen and its partner, Allergan, submitted Avastin's biological product license application (BLA) to FDA, which was accepted in January 2017 According to the requirements of bpcia, Amgen will send the BLA application submitted to FDA and the description of the production process of bio generic drugs to Genentech within 20 days from the date of acceptance Genentech will have 60 days to organize experts to review and determine the possible infringement With the 60 day deadline coming to an end, Genentech urgently needs to find information that may infringe Avastin's patent in the BLA submitted by Amgen Extended reading guide - the increasingly white hot biological analogues compete for biological analogues The English name is biosimilar, which is highly similar to the FDA approved biological products, and there is no significant difference between the safety and effectiveness of the products and the original products in clinical In recent years, the share of biological products in the pharmaceutical market has become larger and larger According to the 2016 annual financial report of major pharmaceutical companies, the main global sales of biological products in 2016 are shown in the table below Sales volume of generic name in 2016 (year-on-year change): Johnson & Johnson's REMICADE infliximab was $6.966 billion (+ 6.2%), Stella ustekinumab was $3.232 billion (+ 30.6%), xarlto was $2.288 billion (+ 22.5%), simponi golimumab was $1.745 billion (+ 31.4%), procrit / efrex epoetin alfa was $1.105 billion (+ 3.5%) and Pfizer was $prevnar pneumococcal 7-value adjust $5.718 billion (- 8%) Enbrel $2.909 billion (- 13) Bayer company (only counting sales in the first three quarters of 2016) eylea Aflibercept € 1.199 billion kogenate antihemophilic factor € 878 million Roche company Avastin bevacizumab CHF 6.783 billion (0%) Herceptin trastuzumab CHF 6.782 billion (+ 4%) Mabthera / rituxan (Oncology) rituximab 5.823 billion Swiss francs (+ 2%) perjeta pertuzumab 1.846 billion Swiss francs (+ 26%) acetmra / roactemra trazumab 1.697 billion Swiss francs (+ 16%) xolair omalizumab 1.498 billion Swiss francs (+ 15%) mabthera / rituxan (immunization) rituximab 1.477 billion Swiss francs (+ 5) Lucentis CHF 1.406 billion (- 10%) activise / tnase alteplase: CHF 1.108 billion (+ 16%) Lucentis rezumab from Sanofi company: USD 1.835 billion (- 11%), Sandostatin octreotide: USD 1.646 billion (1%), cosentix secukinumab: USD 1.128 billion (- -) Lantus insulin glargine: EUR 5.714 billion (- 9.4%) lovenox enoxaparin: EUR 1.636 billion (- 1.7%) Myozyme / lumizyme alglossidase alfa: 725 million euros (+ 13.5%) Cerezyme immunoglucerase: 748 million euros (+ 5.3%) fabrazyme agalsidase beta: 674 million euros (+ 14.7%) Merck Gardasil series cervical cancer vaccine: 2.173 billion dollars (+ 14%) ProQuad, M-M-R Ⅱ and Varivax combined vaccine: US $1.60 billion (+ 9%), keytruda pembrolizumab: US $1.402 billion (+ 148%), REMICADE infliximab: US $1.268 billion (- 29%), pneumovax 23: US $641 million (+ 17%), aimira adamab: US $16.078 billion (+ 16.1%), imbruvica ibrutinib: US $1.832 billion (> 100%), synagis Palivizumab: US $730 million (- 0.4%) Creon pancrelipase: US $730 million (+ 15.5%) kaletra litonavir + lopinavir compound: US $549 million (- 16.9%) ambrel etanercept; US $5.965 billion (+ 11%) neulasta pegfilgrastim: US $4.648 billion (- 1%) Aranesp darbepoetin alfa: US $2.093 billion (+ 7%) Prolia denosumab US $1.635 billion (+ 25%) xgeva Denosumab US $1.529 billion (+ 9%) Lilly company Epogen epoetin alfa US $1.282 billion (- 31%) Humalog Pro insulin US $2.769 billion (- 3%) humalin recombinant human insulin US $1.366 billion (+ 4%) BMS company opdivo nivolumab us $3.774 billion (- -) orencia atacept US $2.265 billion (+ 20%) yervoy ipilimumab With the growing market of biological products, more and more enterprises have joined in the competition of biological analogues, including pharmaceutical giants In 2016, aimira (adamumumab) of Abercrombie was once again the king of drug sales with a sales volume of US $16.078 billion Although it is reported that the sales volume of Humira will reach US $17.6 billion in 2017, a number of imitations have been coveting the huge market of Humira, among which amjevita, the Humira biological analogue of amjevita, is the leading company It was approved by FDA in September, 2017 and will be available in March 2017 In addition, m923 of momenta pharmaceutical and sirukumab of Johnson & Johnson will also have a share in the original market of Humira from 2018 When Johnson & Johnson and Amgen are aggressively setting up the market of biological analogues, their own biological products and drugs are facing competition from other companies' biological analogues In April and August 2016, FDA approved the infactra of celltrion and erelzi of Novartis The two drugs are the biological analogues of Johnson REMICADE (infliximab, sold jointly with Merck, with a total sales volume of US $8.2 billion in 2016) and embrel (enacep, sold jointly with Pfizer, with a global sales volume of about US $8 billion in 2016) 。 Lantus, Sanofi's basic insulin (global sales volume in 2017: 5.714 billion euros), is also a competitor of many biological analogues Among them, basaglar of Lilly and bringer Ingelheim has been approved by FDA in December 2015 Merck's biological analogues are still in the research and development stage, and will be added to Lantus's competition later Roche's other two heavyweight biological products, Herceptin and rituxan, have also been targeted by Amgen, believing that their biological analogues will be available in the next few years Note: This article is original by the author of yaozhi.com, welcome to reprint, please indicate the source and author when reprint, thank you!