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Original research drugs, imitation drugs, biological agents: mantis catching cicadas, after the yellow finch?

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  In the previous 20th century, the pharmaceutical industry was dominated by small molecule drugs. Determine a relatively simple can heal a group of patients with compound, the nature of the patent, obtain profits stable structure means of pharmaceuticals to the progresses day by day, 2012 years later, the total value of $53 billion in the original drugs lose patent protection, and there will be $2014 and $34 billion of the patent medicine patents on bottleneck.

  Original drugs, such as lipitor, celebrex, such as long-term market inspection, curative effect, the patients have very understand these life-saving drugs, the technical advantages, but can"t avoid the generic drug patents expire after market, generics saves expensive r&d and clinical trials of a long, so the price have more advantages than the original drugs on positioning, and market development can even reach the original medicine a points of market share. Generics mantis catching cicada (original drugs) has become the means of many pharmaceutical enterprise success, quickly search for new drugs to replace the drug patents expire, this letter hand to knead to things in the 21st century is more and more difficult, and generic drugs that the mantis may now be a yellowbird goal.

  In 2015, many mature companies and emerging companies sought help in biotechnology. As with other types of drug development, the development of biologics is half a failure and half a success. But "biological agents" the stability of the development process has been gradually established, the biological preparation is composed of large molecules, molecular size is hundreds of traditional drugs, they are in animal cells or microorganisms such as bacteria in production. In 2015, a wave of new biologics is expected to be approved by the FDA and may be prescribed by doctors.

  It is bound to disrupt the 2015 pharmaceutical market

  Tholometrum, a drug used to treat rheumatoid arthritis and related conditions, was approved in the United States in 2002 by the American company abbev. The company, which sold $11 billion in 2013, is the world"s largest prescription drug by sales, according to EvaluatePharma. The huge success of xiolomei has injected a powerful stimulant into pharmaceutical companies, which are scrambling to invest in the development of new biological agents.

  In 2015, several biologic agents for treating high cholesterol will reach millions of patients who have lost their ideal therapeutic benefit from traditional therapies. Evolocumab, an amgen drug, may be the first, followed by sanofi-regeneron, a cholesterol drug, and bococizumab, a powerful early-stage drug.

  According to investment research firm DamienConover of Morningstar, biologics accounted for 22% of the sales of large drug companies in 2013 and 32% by 2023. Pharmaceutical companies such as bristol-myers squibb, Merck, eli lilly and sanofi, whose core businesses include biologics, have seen their revenue growth depend almost entirely on the contribution of biologics. As many as 900 biologics are under development in the United States, where more than 100 diseases are studied.

  In the next five years, a new generation of biological agents has brought new treatments, such as passing through the virus "gene therapy", namely by transferring correct genetic defects to the patient"s cells, replacing the original abnormal genes, cells get normal genes. China has tried gene therapy for a certain type of tumor in 2013. In 2015, the western countries first Glybera gene drugs, will take the lead in Germany as a treatment for lack of lipoprotein lipase genetic disorders (LPLD), developed by the Dutch pharmaceutical companies uniQure, expect a period of treatment need $1.3 million.

  Pharmaceutical companies are scrambling to grab the market

  In order to preempt the gene therapy in the market, Pfizer SparkTherapeutics to establish relations of cooperation, with a biological company aiming at providing a normal gene through gene therapy for patients with hemophilia, make its can produce clotting factors. The scientific literature has reported that 10 patients with severe hemophilia B can live for years with gene therapy. Milo Biotechnology, another pharmaceutical company, is also developing genetic drugs for muscular dystrophy. Regeneron has several will be allowed to biological agents, the boss of LenSchleifer points out that the main advantages of gene medicines is its specificity: they do what they should do, only rarely cause side effects, while traditional small-molecule drugs often cause side effects, it also cause them to gradually abandoned.

  Biological agents in the research process at the same time, will gradually from small arms to common diseases, its strategy when dealing with small arms, will be decomposed into common diseases of various kinds of diseases, so as to realize common diseases and segment of the market, will be on its specificity, targeted biological agents, and the advantages of no side effect to grab the traditional small-molecule drugs market. The near future, eating into traditional patent medicine market is not only the generic drugs, biologics will become traditional patent medicine market and the generics market late winner-take-all "yellowbird", but this only yellowbird before struggling to blow itself there are still many questions waiting for solving.

  1. The development process is fraught with difficulties

  However, the development of the biological preparation of all the difficulties, its usage is also the difficulty, oral will be destroyed in the stomach, must be used for injection, infusion, or suction, which may in some cases hinder the doctor prescribed according to the prescription. Jos carlosgutierrez-ramos, a senior scientist at Pfizer, said the delivery of genetic drugs into the body would continue to be improved so that biopharmaceuticals would one day be as readily available to patients as tablets.

  The advent of biological agents, like other types of drugs, cannot be without obstacles. Shares in roche, the Swiss pharmaceutical giant, fell sharply on December 19th, when it published disappointing results from a combination of Kadcyla and Perjeta2 biologics for cancer patients. In addition, the national institute for health and clinical excellence (NICE) statement, Kadcyla a course of treatment costs about $140000, it is more than the NICE tumor drug price range, the medical insurance is hard to bear with this high price drugs used to treat breast cancer.

  Market development is heavily influenced by price

  Like all new drugs, biopharmaceuticals have not only the problem of competing with the distant effects of existing drugs, but also the problem of whether patients can afford them. For patients who need to take a long-term treatment for rheumatoid arthritis, the cost per person per year is as high as $12,000, and the cost of Humira is much higher. For the developed world, the health care system can no longer afford to pay so much, let alone the poor. As the market share of biologics increases, its price and efficacy will be under strict supervision. By roche, novartis sold two same biological agents used in the treatment of cancer and macular degeneration disease Lucentis and Avastin as an example, although the Italian and French government has found that Avastin can lead to blindness, Italy and France 2 governments or Avastin approved for the treatment of macular degeneration disease, because Avastin price is far lower than Lucentis. In this case, Avastin would save France"s health-care system $273m a year compared with the expensive Lucentis, according to one French lawmaker. That has been a source of frustration for drugmakers. Lucentis is two years behind Avastin, but its sales growth is slowing, probably because of its high prices.

  Research and development costs are getting higher

  When patents on traditional medicines expire, other firms are free to sell generic drugs with the same ingredients. Similarly, when a maker of biologics loses patent protection, rival firms can develop equivalent biologics, known as biosimilars. But biosimilars are much harder to develop than traditional medicines. Biosimilars, as their name suggests, are similar to but not the same as the drug being copied: they can be worse or better, says BenPerkins of EY, a consultancy. In the United States, the lack of clear regulations for approving biosimilars has slowed the development of the market for biosimilars.

  Things are changing, however: Apotex, a Canadian firm, said in more than December that the us FDA had considered its biosimilars, a copy of Neulasta. Neulasta is produced by amgen, an American company, to help cancer patients fight infection. A research and development institutions RAND company in guess that FDA regulations will be how to development, points out that according to the situation that in the next 10 years biosimilars will save $44 billion for the U.S. department of health system. This is a happy number.

  But the overall cost savings from biosimilars are less dramatic than the cost savings from traditional medicines. The first is the high cost of developing and producing biosimilars. The second because of generic drugs is not the same replica, doctors and patients could accept to its speed is slow, so even if the patent expires is difficult to quantify in a short period of time to develop generic drugs, and low development costs than drugs.

  All this is good news for companies that have successfully developed biologics because they are allowed to continue selling them for long periods at high prices. They could face a patent on the revenue fell sharply, but in fact the "bottleneck" patent is not traditional medicines and steep, almost no trouble back at home, so, after the research and development of biological agents routing will gradually out of the small market, and then according to its specific eating traditional medicine market, mantis catching cicada yellowbird behind, there are both from the threat of generic drugs and traditional drugs as well as its generic drugs will face of biological agents it yellowbird market pressure.

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