Refers to original research, self-research and new drugs. Produced by an enterprise with a drug patent right. For example, Sophie Buvir and Havoni, the specific drugs for the treatment of hepatitis C produced by Gilead Company in the United States, are typical original research drugs that have not been approved for listing in China at present.
Second, what is a generic drug?
Not original, just copied the main components of the original medicine. The manufacturer has no patent right for drugs. The price is only 1/3 of the original drug.
Generic drugs contain the same active ingredients as the original drug, which is bioequivalent and consistent with the original drug in dosage form, specification and route of administration.
So, what is the real difference between two drugs that look very similar?
One is production. Similarity: it is the reproduction of the main components. Differences: purity of raw materials, addition of other ingredients, and manufacturing process. The above three differences directly lead to the difference in the degree and speed of drug entering the target tissue.
The second is safety. Because of the long time of test and clinical examination, the efficacy and safety of the original drug are guaranteed A large part of the actual effects and side effects of generic drugs have not been tested for a long time, and the cases are limited, so it is difficult to fully and accurately reflect their actual performance.
The third is the price difference. Article 6 of China's "Measures for Government Pricing of Drugs" stipulates that GMP and non-GMP drugs, original drugs and generic drugs, new drugs and famous drugs, and common drugs should be distinguished, with high quality and good price.
In June 2004, the state approved the latest retail price of products. 10, the lowest price difference is 49% (nifedipine tablets) and the highest price difference is 52.6% (ceftriaxone sodium injection).
Domestic situation: Although the market share of generic drugs is high, patients still require to use the original drug. Shanghai's pharmaceutical industry is also dominated by generic drugs. At present, there are 5430 approval numbers in the city, of which generic drugs account for more than 95%. Peking Union Medical College Hospital will import an original drug or a domestic generic drug when purchasing drugs.
According to pharmacopoeia standards, the quality of generic drugs listed in China is basically qualified, which is chemically equivalent to the original drug, but not completely bioequivalent and clinically equivalent.
Take "metformin, a hypoglycemic drug produced by Sino-American Shanghai Squibb Pharmaceutical Co., Ltd." (trade name Gehuazhi, domestic generic drug is generally called metformin) as an example. Although hundreds of enterprises in China imitate metformin, Gehuazhi's annual sales in China exceed 200 million US dollars, accounting for 70% of the whole metformin market in China. This is because the domestic metformin looks no different from the original drug, and the price is much cheaper than the original drug, but there are still many patients who require to use the original drug in clinic.
Another example is vitamin C effervescent tablets that people often eat. The original drug is put in a glass of water, which has good solubility, like a glass of orange juice; However, the imitations of some domestic enterprises are put in water cups, but they get together and have poor solubility.
In this regard, the hospital's approach is-"For critically ill patients, the original drug is the first choice for emergency rescue."
During the Twelfth Five-Year Plan period, the quality of generic drugs in China has been significantly improved. Especially in 20 13, the state food and drug administration of the United States issued a notice on the quality consistency evaluation of generic drugs, and the approval standards of generic drugs in China were in line with international standards. However, those drug varieties approved before the implementation of the revised Measures for the Administration of Drug Registration in 2007, although in line with the Pharmacopoeia standard (also known as the national standard), only copied the chemical structure and dosage form, lacking the study of bioequivalence and clinical equivalence, which is far from the international standard.
If the original drug is 10, the generic drug is 6.