Tragedy of Aberdeen, MSD / Johnson! EMA accepts the listing application of two bio generic drugs of Sandoz

Source: Sina pharmaceutical 2017-06-01 Sandoz, a generic unit of Novartis, recently announced that the European Drug Administration (EMA) has accepted the application for marketing permission (MAA) of two bio generic drugs submitted by the company, one of which corresponds to the original research drug Humira (sumil, generic name: adalimumab, adalimumab), the flagship product of Aberdeen, and the other to the original research drug mo REMICADE, a heavy-duty anti-inflammatory drug of Sadong and Johnson & Johnson, is used to treat immune diseases The regulatory documents submitted by Sandoz seek the approval of the European Commission (EC) for all indications of the two bio generic drugs for their respective reference drugs Dr mark levitk, global head of biopharmaceutical development at Sandoz, said that patients with autoimmune diseases (such as rheumatoid arthritis [RA] and inflammatory bowel disease) rely on biological agents such as adalimumab and infliximab to maintain their health, but unfortunately, patients' access to such basic drugs is still limited EMA accepted the regulatory application documents of two bio generic drugs submitted by the company, marking an important step towards improving patients' access to important biological preparations The submission of these two biosimilars MAA is based on two comprehensive clinical development projects, including pharmacokinetic / pharmacodynamic, efficacy and safety data of analytical, preclinical / clinical studies These projects respectively proved the biosimilarity of these two bio generic drugs compared with their reference drugs The research in the development project of adamumumab biosimilars includes: pharmacokinetic (PK) research, and a phase III validated efficacy and safety study in patients with moderate to severe chronic plaque psoriasis Studies in the infliximab biosimilars development project include a PK study and a phase III validation efficacy and safety study in RA patients Up to now, Novartis has three kinds of bio generic drugs on the market In April this year, the biosimilar rituximab and biosimilar etanercept developed by Sandoz also received positive suggestions supported and approved by the EU CHMP Sandoz has planned to launch five important biosimilars of oncology and Immunology biological preparations in key geographical regions of the world by 2020, targeting brands of drugs: Enbrel (Amgen, 2016 global sales $6 billion), Humira (ebwi, 2016 global sales $16.1 billion), neulasta (Amgen, 2016 global sales $4.65 billion), REM ICADE (Johnson & Johnson, with global sales of nearly $7 billion in 2016), rituxan / mabthera (Roche, with global sales of $7.3 billion in 2016), the total sales of these brand drugs in 2016 reached $41 billion (data from Sina pharmaceutical article: sales data of core products of 16 foreign pharmaceutical companies in 2016) in recent years, biological agents have completely changed the clinical treatment of many disabled and even life-threatening diseases However, the reality is that whether developed or developing countries, drug access is still the largest unmet medical demand It is estimated that at least 400 million people worldwide do not have access to basic medical services, and more than 2 billion people cannot afford the medicines they need The high-quality bio generic developed by Novartis Sanders has clinical comparability with the original research drug, and can provide up to 75% discount in some cases Its purpose is to significantly expand the global patients' access to high-quality and low-cost bio generic drugs Currently, there are about 1000 molecules in Sandoz pipeline assets, covering all important treatment areas In 2016, sales of Sanders products reached $10.1 billion, and the number of patients treated exceeded 520 million At present, the pharmaceutical industry is very optimistic about the market prospect of bio generic drugs According to a report released by the IMS, expanded access to biosimilars in Europe and the United States will save the health system as much as $110 billion by 2020.