Injection vs. Oral Solid Preparations

From the perspective of various stages, there are big differences between domestic generic drug injections and oral solid preparations in terms of generic drug consistency evaluation, competition pattern, and overall market size.

Domestic sales of injections account for too much

From the PDB sample data, injections account for more than 60% of domestic prescription drug sales. Among them, on the one hand, the unique domestic traditional Chinese medicine injections have increased the proportion, on the other hand, there is a phenomenon of excessive use of injections in domestic prescriptions.

Injections include three categories: chemicals, biological products, and Chinese patent medicines. Among them, chemical injections accounted for 72%, mainly including antibiotics glucose, sodium chloride, etc.; biological product injections accounted for 16%, mainly including monosialotetrahexose ganglioside sodium, calf blood deproteinized extract, Insulin, etc.; while the share of traditional Chinese medicine injections is 12%, mainly Xueshuantong and Ginkgo biloba.

Large variety comparison: The proportion of domestic injection preparations far exceeds that of the United States

In the case that there are multiple preparations of the same product, the domestic clinical preference is to choose injections, and the proportion is much higher than that of the United States. The reasons may be: the cost of injections of the same therapeutic amount is higher than that of oral preparations, and the prescription power is stronger; injections have quicker effects and are more suitable for the domestic medical environment where the relationship between doctors and patients is strained.

Consistency evaluation of generic drugs: Oral preparations and injections have different gold contents

At present, the consistency evaluation of generic drugs is mainly for oral solid preparations, and the consistency evaluation of injections is officially launched. However, since the CFDA’s draft for comments on injections has been released, I believe that the formal standardization of injection consistency evaluation will not be too far. From the perspective of evaluation methods, oral solid preparations have issued evaluation guidelines for pharmaceutical research + BE testing; injections have no dissolution and absorption problems, and the main concern is impurity control and safety, and the evaluation is relatively simple.

It is difficult to evaluate the consistency of oral solid preparations

The preparation process requires high: Before 2007, a large number of generic drugs were put on the market without strict review, and the quality was uneven, which was also the focus of this consistency evaluation. If the enterprise wants to put forward higher requirements on the formulation process through the consistency evaluation, the era of low-level imitation in the past will be gone forever.

High evaluation cost: According to the quotations of 1 to 2 million for pharmaceutical research and 2 to 3 million for bioequivalence evaluation, the cost of single-variety evaluation is about 5 million. In the case of shortage of clinical data and the clustering of varieties to be evaluated, it will be further Increase.

Time is tight: the guidance document requires “289 basic drug varieties to complete the consistency evaluation in 2018”, “After the first product has passed the consistency evaluation, the consistency evaluation of the same varieties of other companies should be completed within 3 years, and no re-registration will be allowed after the deadline.” .

Time is tight and tasks are heavy, and companies’ demand for CRO continues to increase

With the development of generic drug consistency evaluation, the attitudes of pharmaceutical companies of different scales and companies in different regions to CRO have been improving. Especially in Asia, the positive attitude of companies has increased significantly, and the enthusiasm for R&D outsourcing is increasing. . In the past ten years, the penetration rate of CRO has gradually become clear. The current global penetration rate of CRO has reached 40%. Frost & Sullivan predicts that there is still a large room for increase in CRO penetration in the future.

It can be seen from the data that the CRO penetration rate continues to rise due to the implementation of the generic drug consistency evaluation work, which can also indicate that my country’s CRO industry will continue to benefit. According to incomplete data, China’s domestic pharmaceutical market has maintained a high industry growth rate in the past ten years, and the domestic CRO industry has also achieved rapid development. For example, Tiger Pharmaceuticals, my country’s first CRO company, and WuXi AppTec, Kanglong Chemical, Medicilon Biologics, and Herui Sunshine, which have already exceeded 50 million sales at the age of 3, have already submitted the prospectus.

From the perspective of the domestic market structure of modern pharmaceutical products to be evaluated, injections vs. oral solid preparations: two dosage forms, and two markets are gradually becoming clear. This also increases the broader opportunities that my country’s CRO industry is facing, and the generic drug consistency evaluation policy will bring a definite market increase for my country’s CRO industry.