"Like her, but not her", biopharmaceuticals also play "substitute stalks"?

"Biomimic or Biocopy", this topic around different biopharmaceuticals should start with this new term.

Presumably, many people see the first reaction of the word "biological approximation medicine": what is the difference between it is similar to biological drugs? Speaking of biological medicines, it is impossible to go around the original biological research. So what is the relationship between the three?用小说里常见的设定打个可能不太恰当但让人一听就明白的比方：生物原研药像是“白月光”，生物类似药和生物近似药则像是“替身”，像她， It's not her.

There is an incredible gap behind the difference between the difference

According to domestic and foreign biological drug -related management standards, biological preparations can be divided into:

(1) Original Biology, which is the original biological products used by regulatory agencies for specific indications.

(2) Biosimilar, that is, biological products approved by the similarity of similar drugs in terms of quality, safety, and effectiveness by regulators. Regarding the definition of similar biological drugs, the standards of each region are slightly different. my country's Drug Administration (NMPA) stipulates that biological drugs are similar to the original research medicine in terms of quality, safety and effectiveness. The European Drug Administration (EMA) pointed out that the two are similar. The US Food and Drug Administration (FDA) pointed out that there are small differences between the clinical non -active components of biological drugs and the original drug, but there is no clinical difference in safety, purity, and product performance. It is not difficult to find that the standards in each region are not difficult to find. The recognized criteria for biological similar drugs in the world are: similarity to reference biological products in terms of quality, safety and effectiveness.

(3) Biomimic (biomimic or biocopy), which is defined as: biological products that are similar to the original biological drug, but do not follow strict regulatory approval procedures. There are more or less different aspects of quality, stability, efficacy, safety and other aspects. It may be understood that it has not performed similarity with the quality, safety and effectiveness with the original drug of biological research.

Similar and similar, the difference between the word becomes different. If you compare biological similar drugs and biological approximate medicines from various aspects, the conclusion is very obvious.

First of all, it should be clear that similar drugs are similar to biological approximation medicines.

As far as concepts are concerned, although the biological approximation medicine emphasizes that although it has been approved by the market, its approved time is before the implementation of biological pharmaceutical regulations, or in accordance with relevant regulations, and belongs to non -innovative biological products.

From the perspective of review procedures, the biological approximation medicine has not been reviewed by the corresponding regulatory agency. Without regulatory channels, it is "not regulated", and the biological similar drugs and the original drug are strictly reviewed by the corresponding institutions.

In terms of safety, taking Lichell Mipida as an example, when the original drug transitions used the approximate drug, many patients had an allergic reaction and were recalled. It is not uncommon for similar "not necessarily safe" biological approximation drug accidents. Essence

But biological approximation medicines and similar medicines are not an insurmountable gap. Some experts pointed out that all biological approximation medicines need to be proved their effectiveness and safety through carefully designed clinical trials, and they are approved by the approval of biological similar drugs recommended by WHO. Similar biological medicines. It is not difficult to see that this process is time -consuming and consuming a lot of money. Because of this, some creatures may not necessarily choose to complete the relevant tests.

All in all, the key to cross -gaps in the gap is that according to the approval process of various countries, the study of the equivalent of comparison with the "head opposite" of the original biological research drugs has achieved certain requirements.

A original research medicine that does not want to be "heat"

Understand the connotation of these three nouns, and emphasize: The quality, stability, curative effect, and safety of some biochemical drugs may not be satisfactory. It must also be admitted.

Back to this topic today. In one sentence, it is: this biological original medicine does not want to be "hot".

If the original biological research will speak, the first sentence it says may be: "I am me, I am unique, don't confuse me with other medicines."

For a long time, the natural existence of tissue iconic iconic activation protein (TPA) derivatives obtained by the RT-PA as DNA reorganization technology, in the field of thrombolysis, especially acute ischemic stroke (AIS), Patients play an irreplaceable role in thrombolysis. In recent years, the original thrombolysis biological drug produced by Bollinger Yingehan Company has also paid attention to the treatment of acute ischemia. Compared with Achinase, it has a longer semi-life period, has a higher specificity to fibrin, and has higher resistance to fibrobine-oligomer inhibitors-1, showing that it will be used in acute ischemic stroke thrombolysis in the future Treatment potential.

In various studies in the treatment of acute ischemia (AIS), biological research TNK shows certain potential advantages. For example, TASTE-A studies at random, open labels, and blind method evaluation have been included in 104 patients. The results show that compared with TPA, patients with the original TNK in the mobile stroke unit (MSU) were used for early-stage thrombolytic treatment. The re-pass rate is higher and there is no security risk; when Extend-IA TNK (LVO ≤4.5H) confirms that patients who receive the original TNK before taking the embolism are higher and the prognosis is better. Tempo-1 (MINOR-Steke) studied the conclusions of the original TNK treatment with light strokes with intracranial occlusion. Safe and effective drugs are more likely to be favored. Based on the above studies, domestic and foreign guidelines are mainly made of TNK -related recommendations among large blood vessel occlusion (LVO) and light stroke patients, and relevant evidence is based on Boliner's original TNK -related research. However, for the overall AIS patients, the domestic and foreign guidelines are still recommended by Class I, and the recommendations of TNK are also based on Boliner's original research evidence of TNK.

In contrast, no other TNK has any clinical research as a guideline evidence.

At present, there is a biological approximation of biological research TNK in foreign countries. For example, in India's trademark name ELAXIM®, in the published studies, compared to the biological activity and thrombolytic performance of Boliner's original TNK drugs, ELAXIM® -TNK's thrombolysis activity is inferior. The reason is that the relative abundance of the ELAXIM®-TNK dual chain form is half less than that of Boliner's original TNK, so the dissolution activity is low. At the same time, the differences in the structure, impurities, and related fibrous soluble activity shown by the institute may be converted into the difference in efficacy and safety.

At present, TNK has not been listed in the current research of biological Biolinge, but there are other TNK biomedicine listed. At present, it is only approved for myocardial thrombolysis, but no study has been conducted to confirm that it is equivalent to the original TNK of Bollinger. , TNK cannot be pushed to TNK at this time, nor can it be used to use the effectiveness and safety of the global clinical research on TNK.

TNK currently listed in China is not a biological similar medicine for biological medicines

Drug clinical trial registration and information publicity platform shows that TNKs listed in China have completed two studies. Trace I (≤4.5h) is one of them. The study is designed with multi -center, random, open label, and blind evaluation endpoint (Probe), which is included in 240 patients. Although the research results show that similar to white people, Chinese acute stroke patients have good tolerance for TNKs that involve dosage within 3 hours of symptoms, but the best effective dose of this TNK still needs to be in the future large sample sample The study is further clarified. At the same time, the sample volume of the study is small, and the source of the patient is too concentrated (about 1/3 from a single hospital).

Another Chablis-T research, incorporated into 86 patients, testing for forward-looking, multi-center, random, and open label random test. The safety and effectiveness of simple thrombolytic groups have a better trend than the bridge connection group. However, this is contrary to the conclusions of clinical research of many similar designs.

In summary, TNK, which has not been approved by the domestic listing, is not a biological drug of Boliner's original TNK. It cannot be used to use Boliner's original TNK -related research evidence to extract its efficacy and safety. At the same time, domestic and foreign guidelines have recommended the use of TNK for patients with AIS. The relevant evidence is based on Boliner's original research TNK international research, which has nothing to do with this TNK.

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