What are Generic Drugs?

A generic drug is a copy that is the same as a brand-name drug in terms of dosage, safety, and strength (regardless of how it is taken) , quality, performance, and intended use . There will be more than 150 kinds of patent drugs in the world with a total value of more than 34 billion US dollars. After the expiry date, other countries and pharmaceutical factories can produce generic drugs.

On March 6, 2016, the General Office of the State Council recently issued the "Opinions on the Consistency Evaluation of the Quality and Efficacy of Generic Drugs", which requires that generic drugs approved for marketing before the new registration classification of chemicals are implemented. Approval by the principle of consistency shall be carried out for consistency evaluation.

Generic drugs are drugs that have the same active ingredients, dosage forms, routes of administration and therapeutic effects as the original drugs. To conduct a consistency evaluation of quality and efficacy, it is required that the generic drugs that have been approved for marketing should be consistent with the original drug in quality and efficacy, and can be replaced with the original drug clinically, which is conducive to saving medical costs in society.

The national solid medicine list (2012 edition) of the oral solid preparations of generic drugs for chemicals approved for marketing before October 1, 2007 should be evaluated for consistency by the end of 2018. For other generic drugs approved for listing before the implementation of the new registration and classification of chemical drugs, since the first product has passed the consistency evaluation, the same product of other drug manufacturers should, in principle, complete the consistency evaluation within 3 years; registered. ^[1]

In January 2019, 12 departments, including the National Health and Health Commission and the National Development and Reform Commission, jointly issued the "Work Plan on Accelerating the Implementation of the Supply and Use Policy of Generic Drugs", and proposed to publish the first batch of generic drug catalogs by the end of June 2019 to guide Enterprise R & D, registration and production. According to the demand for clinical drugs, starting from 2020, a catalog of drugs to encourage imitation will be released before the end of each year ^[2] .

Introduction to Generic Drugs

Generic drugs are substitute drugs with the same active ingredients, dosage forms, administration routes and therapeutic effects as the generic drugs. They have important economic and social benefits such as reducing medical expenses, improving drug accessibility, and improving medical services.

Relevant US FDA documents point out that a generic drug that can obtain FDA approval must meet the following conditions: it must contain the same active ingredients as the generic product, and the inactive ingredients can be different; and the indication, dosage form, specifications, and route of administration of the generic product Consistent; bioequivalent; quality meets the same requirements; GMP standards produced are as stringent as the imitation products.

History of generic drugs

The origin of generic drugs is attributed to the Waxman Act passed by the FDA in 1983. The bill benefits both generic and innovative drugs. For generic drugs, it is not necessary to repeat the years of preclinical animal studies and human clinical studies conducted before the approval of innovative drugs, but to obtain approval through proof and bioequivalence of original drugs. For innovative drugs, an extended period of protection beyond the patent protection period has been obtained. The bill benefits patients even more. Generic drugs accounted for only 11% of the US pharmaceutical market in 1983, and reached about 50% in 2012, greatly saving patients' drug costs.

Differences in generic drugs

China is a country that mainly produces generic drugs, and the original R & D drugs have only been valued after China's entry into the WTO. Developed countries coexist. Therefore, the concept of the difference between the efficacy of the original drug and the generic drug has penetrated into the minds of doctors and patients in developed countries. In a foreign country, when a patient goes to a pharmacy with a doctor's prescription for dispensing, the pharmacist will ask the patient, do you want the original drug or a generic drug? Patients can make their own choices based on their condition and doctor's recommendations.

The American College of Family Physicians published a "White Paper on Generic Drugs" at the 1998 Annual Meeting based on the conclusions of the American Drug Use Committee's two-year research on generic drugs. The White Paper details the problem of drug substitution and emphasizes random changes. Drug dangers.

"In the generic drug license, its bioavailability means that the generic drug has a tested response of +/- 20% of the original research and development product." Therefore, it is difficult to fully guarantee the effectiveness and safety of the generic drug.

"Many generic drugs contain different additives and intrinsic ingredients, which are different from the drugs of the original research and development pharmaceutical factory, so they are not considered to be bioequivalent." The generic drugs just copied the molecular structure of the main components of the original research and development drug. The addition of other ingredients in the original drug is different from that of the generic drug, so there is a difference in efficacy between the two.

"For critically ill patients, drugs needed in critical situations, and critical illnesses, imitation drugs cannot be replaced compulsively." In emergency patients, try to use the original research and development drugs. "The American Academy of Family Physicians believes that generic drugs have limited permits to replace original drugs."

Although the White Paper of the American College of Family Physicians is non-regulatory, the research report uses facts to show that the efficacy and safety of the originally developed drugs are irreplaceable with generic drugs, especially when treating critical patients and critical diseases.

However, the original research and development medicine is too expensive, and it does not meet the needs of ordinary people. Doctors should not vigorously talk about the original strengths in front of ordinary people. After all, the price strength lies in the generic medicines.

Generic drug protection period

In the future, China's pharmaceutical market will usher in the period of the most expired patented medicines in the history of pharmaceuticals, and there will be more than 160 kinds of patented medicines with a total value of more than $ 34 billion in the world.

Relevant statistics show that China's pharmaceutical market will usher in the most expired period of patent drugs in the history of pharmaceuticals. There will be more than 150 types of patent drugs with a total value of more than 34 billion U.S. dollars in the world. Some "heavy bombs" such as imipenem / cilastatin and atorvastatin, and 2005-2007 will be the peak period for patent medicines to expire. At present, China's pharmaceutical companies have entered the climax of applying for generic patent drugs. However, in terms of generic drugs, there is still a big gap between China and some developed or developing countries. Foreign generic drugs in full swing

The United States is the most developed country in the pharmaceutical industry in the world. It is also the country with the strongest ability to create pharmaceutical products and the loudest patent protection in the world. However, 40% to 50% of prescription drugs used by Americans are generic drugs, and generic drugs are increasing at an annual rate of 15%. Because of the production of so many generic drugs, the increase in the price of pharmaceuticals in the United States has slowed. In 2002, the 200 popular generic drugs in the United States sold a total of 28.53 billion U.S. dollars. Generic drugs can be used by 40 million medical insurance providers in the United States a year. With a savings of $ 14 billion, it is no wonder that the United States has become the world's largest generic drug market.

Generic market

Not only in developed countries, but also in developing countries. Although China's close neighbor, India, is also a large developing country like ours, the role of generic drugs in the global pharmaceutical market is increasing. According to Indian customs statistics, most of the drugs exported by India each year are generic drugs. In 2000, The export value of generic drugs has reached 1.6 billion U.S. dollars and is expected to reach 5 billion U.S. dollars in 2005. Except for the export of a few traditional Chinese medicine products, the export of chemical preparations in China is only tens of millions of dollars.

It is understood that the Indian pharmaceutical industry has attracted attention. In 2012, at least 20 pharmaceutical companies in India passed the US FDA certification. Among them, Nanxin and Cipla are growing into multinational pharmaceutical companies. Nanxin's generic drugs in 2012 Has achieved 10% market share in the United States.

Relevant experts believe that the biggest benefit of generic drugs is greatly reduced drug prices. If there is a medicine, the inventor would sell it for $ 6,000 per ton and copy it in India after the protection period. It would only sell for $ 60 per ton, which greatly stimulated consumption. For another example, in February 2011, CIPIN, headquartered in Mumbai, announced that it would reduce the price of the original three-in-one drug for AIDS to US $ 350, which is less than US $ 1 per day, which is significantly lower than the price of the original drug. This move Multinational pharmaceutical giants have been shocked that India s anti-AIDS drugs have been killed in Africa and Latin America and other non-patent countries.

Not long ago, foreign media reported that the pharmaceutical giants had abandoned the "blockbuster" drugs and turned their attention to generic drugs. China's generic drugs need to be improved.

Although the pharmaceutical industry in China has made great progress since the founding of the People's Republic of China, from the basic blanks of the pharmaceutical industry to 2012, it can basically meet the needs of citizens in general use. However, we have to admit that China's pharmaceutical industry is a weakness in the creation of new drugs. Creating a new drug requires huge financial, material and human resources, as well as great risks. Based on China's national conditions, limited financial resources and weak pharmaceutical research capabilities, it is impossible to make a fuss about creating new drugs.

Therefore, from 1950 to 2012, the vast majority of new drugs marketed in China were generic products, with generic drugs accounting for more than 97%. However, the gap between the production of generic drugs in China and the United States, India and other countries lies in the low-level imitation and low-margin melee. At present, there are more than 6,000 pharmaceutical factories in China, but most of these manufacturers compete at a low level of price level. In this case, the average profit of generic drugs is only 5% to 10%, which is 40% to 60% of the international average. Profit margins are not comparable. Generic drugs are also being developed.

In response to the above-mentioned phenomenon, relevant experts have called for even the "new" word to be an article, even for generic drugs. Zhu Baoquan, former president of Shanghai Pharmaceutical Industry Research Institute and dean of Shanghai Jiao Tong University School of Pharmacy, at the "2003 International Pharmaceutical Conference" held in Shanghai on November 4, 2003, called for the focus of imitation on new dosage forms and new processes. In the development of new technology, it is necessary to choose the original brand medicine with a certain market, less patent disputes, and a certain degree of difficulty in the process to avoid competition. He also believes that vigorously developing generic drugs will be the first choice for Chinese pharmaceutical companies. Eastern European, Indian, South American and other companies producing generic drugs are grabbing the European and American markets at low prices. There is no reason for Chinese pharmaceutical companies to stand still. The country should encourage domestic enterprises and scientific research. The unit strengthened the research and development of generic drugs.

Of course, in the long run, the combination of imitation and innovation is the only way for China's chemical and pharmaceutical production. Yu Mingde, former deputy director of the Economic Operation Bureau of the State Economic and Trade Commission, said that the Chinese pharmaceutical industry is currently encouraging the development of generic drugs. Yu Mingde believes: "China's national conditions determine that drug research and development will take three steps. The first step is complete imitation, the second step is imitation innovation, and the third step is to achieve independent innovation." I believe that the development of non-patent Drugs, which are generic drugs, can play a significant role in China's pharmaceutical products entering the international market. The key is to improve the technical grade and product quality of generic drugs.

Analysis of the generic pharmaceutical industry

The cake of China's generic drug market is sour and sweet for foreign pharmaceutical companies. On the one hand, China is the world's largest generic drug market, and on the other hand, foreign pharmaceutical companies face difficulties in bidding for essential drugs. However, this still cannot stop the pace of foreign pharmaceutical companies entering the Chinese market.

Following the merger and acquisition of Guangdong Become Pharmaceutical, AstraZeneca spent US $ 230 million (about 1.45 billion yuan) to set up the world's largest independent production base in Taizhou, Jiangsu, which will mainly produce brand generic drugs. And this cake is not only AstraZeneca's family. In 2012, Pfizer, GlaxoSmithKline, Novartis and many other foreign pharmaceutical companies are actively planning.

Generic drugs are huge

The global generic drug market size in 2011 has exceeded USD 130 billion. In the past 10 years, the growth rate of the global generic drug market has more than doubled that of patented drugs. The next few years will be the peak of drug patent expiration, and from 2011 to 2015, it is estimated that 77 billion US dollars of patent drugs sold will expire. With this huge market, many foreign-funded pharmaceutical companies, mainly new drugs, have begun to readjust their strategic plans.

Although China is the world's largest generic drug market, this cake is sour and sweet for foreign pharmaceutical companies. Under the new medical reform policy, China has increased its support for primary medical institutions, which will greatly boost the demand for high-quality and cheap generic drugs. According to the forecast of IMS Health Consulting, the annual growth rate of generic drugs in China will exceed 25%.

Huang Bin, executive director of AstraZeneca's pharmaceutical affairs and brand generic drugs, said that foreign companies do face difficulties in bidding for essential drugs, but this mainly depends on the affordability of the company. If the price is lowered by reducing costs, foreign companies can also seize the market.

Acquiring small factories into focus

The acquisition of a small pharmaceutical company in China is conducive to quickly obtaining a market approval for the product and can also quickly cut into the original market. AstraZeneca said it will acquire small Chinese pharmaceutical companies to enter generic drugs. AstraZeneca has signed a purchase agreement with Guangdong Beikang Pharmaceutical Co., Ltd., a private generic drug manufacturing company in Guangdong Conghua, in January 2012. It intends to focus on the production and sales of anti-infective drugs.

The measures to build production bases and acquire Chinese small and medium-sized pharmaceutical companies are not only adopted by the AstraZeneca family. Data from the Pharmaceutical Research and Development Industry Committee (RDPAC) of the China Association of Foreign-Invested Enterprises shows that in 2012, more than 70% of the 37 member companies of the association had set up production plants in China and the number of factories reached 50. In terms of mergers and acquisitions, Novartis signed a strategic agreement with Huahai Pharmaceutical. The main direction of cooperation is drugs with expired patents. Pfizer also established a joint venture with Zhejiang Hisun Pharmaceutical with a total investment of US $ 295 million. The company is positioned to produce branded generic drugs. ^[3]