2015 global biopharmaceutical industry event!

China's pharmaceutical industry has undergone extensive and profound changes in 2015, which makes people feel shocked and at a loss For example, the consistency evaluation of generic drugs continues to deepen , the new policies of drug administration came one after another (in-depth observation of the 2015 China drug regulatory policy storm), and the clinical self-examination was vigorous (collapse, drug companies withdraw varieties like the tide!) The filing system of bioequivalence test was put into effect on December 1 Are you ready To strengthen the communication of evaluation (how do children in other families communicate with CDE?) Children's drug priority review has nothing to say The first sentence we met was to ask each other, "how are you doing?" Hi.. 2016 is coming, can it be worse? The atmosphere at home is very depressing What's the situation abroad? What else do you know, besides the tumor immunotherapy that has been swiped, Pfizer's acquisition of Allergan, the arrest of bad boy Martin shkreli, and the FDA's annual approval of new drugs that will soon be swiped? Today we use 5 key words to show you the style of global biopharmaceutical industry this year! Drug prices and drug prices have attracted attention throughout 2015, and are more lively than in previous years Sovaldi and harvoni, the hepatitis C drugs, still sold $14 billion (in the first nine months of this year) along the way, indicating that patients have just needed the landmark drug, while the government and healthcare payers have little way to do with Gilead's strength Martin shkreli, CEO of Turing pharmaceutical company, raised the price of daraprim, an old patent expired drug, from $13.50 to $750, which was even more offensive As American pharmacies decided to use $1 alternative drug and Martin shkreli was arrested by the FBI for financial fraud, Martin shkreli's farce finally came to an end（ How can drug pricing be described as "industry conscience" Michael Pearson, one of the worst CEOs of the year, is also constantly "messing up" on drug prices and teasing the nerves of the U.S government (CEO of the world's "worst" biopharmaceutical company in 2015) In addition to being criticized by JAMA dermatology magazine for the soaring price of two dermatology drugs (the price of dermatology drugs in the United States has increased by 400% compared with 2009), Valeant has always adhered to the business operation idea of "acquisition monopoly price increase" and played a vicious role in collusion with pharmacies, which attracted the investigation of Congress of the United States, the securities and Exchange Commission of the United States and the Justice Department of Canada Of course, British nice refuses to use new drugs from major pharmaceutical companies on the grounds of low cost performance (what is the experience of foreign "1.1 new drugs" failing to enter the medical insurance?) almost every day What's more noteworthy is that ASCO published a "cancer drug value framework" in JCO in June this year, which helps clinicians and express s s cripts, the US pharmacy welfare management agency, score cancer drugs to cope with the increasing cost of cancer drugs In recent years, one of the driving forces of global pharmaceutical enterprises' large-scale M & A is to reasonably avoid taxes through tax inversion Many American pharmaceutical enterprises will move their headquarters to countries with lower taxes through M & A Although there are deals and mergers every year, Pfizer bought Allergan with us $160 billion this year, setting a record in the history of pharmaceutical enterprises' Mergers and acquisitions, which is still worthy of us to list "deal and merger" as one of the key words of the pharmaceutical industry in 2015 Some politicians in Washington are still calling for Pfizer and Allergan to stop the transaction The U.S government is also considering amending the current tax law to increase the cost of future tax reverse transactions This may avoid the big companies like Lilly, Gilead and Amgen easily moving their headquarters overseas, which has little impact on the implementation of Pfizer Allergan transactions (pharmaceutical company vs Biotech Corp: recovery or bubble? In addition to the merger and acquisition between enterprises, pharmaceutical companies are also sparing no effort in drug and technology transactions to strengthen the strength of pipeline products (2015 global heavyweight drug trading market), not to mention the outrageous act of spending 350 million dollars to buy a priority review coupon (Disclosure of FDA priority review coupon: Novartis is the most tragic, Sanofi is the most fun!) Over the years, FDA has spared no effort to instill in pharmaceutical companies the idea that "the promotion of drugs with super labels is a serious violation of regulatory rules" In 2012, the U.S Federal Court of appeal rejected the accusation against a pharmaceutical representative of orphan medical (now Jazz pharmaceutical) to promote drugs with super label according to the first amendment, which made the pharmaceutical industry expect the FDA to loosen its policy of strictly prohibiting the promotion of drugs with super label, but there was no breakthrough in this respect in the following years In May this year, amarin, an Irish pharmaceutical company, formally filed a lawsuit with the federal court against the FDA, arguing that the FDA's ban on discussing indications other than the label of vascepa (ethyl eicosapentaenoate) violates the First Amendment's right to freedom of speech, which prevents amarin from sharing "true and non misleading" information with clinicians and patients Vascepa is only approved by FDA and combined with diet to reduce the TG level of patients with hypertriglyceridemia (TG ≥ 500mg / dl) Amarin believes that the FDA's prohibition of its propaganda of vascepa can reduce the TG level of patients with Hypertriglyceride and reduce the risk of coronary disease violates citizens' right to freedom of expression On August 6, amarin won the federal court Amari's "unprecedented" victory may be seen as a turning point for the FDA in managing the promotion of drug super labeling In 2012, the postoperative analgesic experel of pacira pharmaceutical company was only approved for the treatment of pain after cyst resection and hemorrhoidectomy In September 2014, FDA issued a warning to pacira pharmaceutical company that it would promote experel for various types of surgery Pacira then sued the FDA, citing the First Amendment's right to freedom of speech Finally, the two sides reached a settlement on December 16 The sales restriction of experel was lifted, and the drug label was changed to be applicable to any postoperative site analgesia It's not clear how the FDA's attitude will change, but these two events in 2015 will definitely prompt the FDA to reflect on how to supervise the drug companies to promote "correct and non misleading information" behavior Compared with the United States, the European Union is more open in the treatment of biological analogues As early as September 2013, the European Union approved the first biological analogue, infactra, which mimics the disease drug REMICADE (infliximab) of Johnson / MSD For the United States, the world's largest drug market, although in August 2014, FDA also tentatively approved Lilly / bringer's Lantus generic drug (peglispro, a long-acting insulin with better efficacy than Lantus, how was it abandoned by Lilly in phase III?) But the first real biological analogue is that Sandoz, a subsidiary of Novartis, which was approved by FDA in March 2015, imitates Amgen's heavy-duty chemotherapy adjuvant, fegeristine Amgen also filed an application for listing ABP 501, the first biological analogue of Humira, the world's best-selling drug, to the FDA on November 26 FDA's embrace of biosimilars means that the spring of biosimilars is coming With the listing and application of biosimilars such as fegeristine, insulin glargine, etanercept, adalimumab, etc., biosimilars will play an increasingly important role in the global drug market after 2016 (the trend of research, development and application of Chinese monoclonal antibodies) When innovative politicians and mass media criticize Biopharmaceutical Enterprises for their profit-making, one of the most easily forgotten things is the breakthrough that pharmaceutical enterprises bring to medicine driven by their interests Large pharmaceutical enterprises (such as BMS and MSD) have played a key role in the promotion of tumor immunotherapy In 2015, biotechnology companies were generally regarded as the main force of technological innovation in the pharmaceutical industry ("Roche, who left behind in the tumor immunotherapy competition, was playing the second generation car-t therapy?) In the past 12 months, a series of new technologies of tumor immunotherapy, including car-t cell therapy and gene therapy, have made great progress, showing you a lot of practical clinical data of new technologies used in blood tumors (car-t disclosure: understand the global R & D pattern of car-t therapy in one article!) In 2015, CRISPR gene editing technology known as "magic scissors" was also dazzling The new company CRISPR therapeutics based on this technology has been favored by Bayer, Novartis and other giants Although there are still doubts, the slow and fluctuating development of these new technologies still proves that innovation is the inexhaustible power of medical progress.