Attack or defense? The pharmaceutical market is going to change
In 2018, China's pharmaceutical industry will usher in a decisive year of consistency evaluation. Whether it's the aggressive offense or the defensive choice of the rafer in the big wave, it's a sign that the overwhelming consensus is about to shake things up.
The forerunner's victory is in sight
In fact, a large number of generic drug companies have started to evaluate the consistency of their key varieties. However, the competitive listed pharmaceutical companies have already rearranged and distributed their generic drugs, even if many of them are not in the "289 catalogue", after all, big enterprises have more gaming chips.
By November 20, the general administration had accepted all applications for 30 varieties, including 8 applications for not changing the prescription technology and 22 applications for changing the prescription technology. The first batch of approval results of varieties accepted by CDE could be issued as early as December this year or January next year. That means the companies will be the first to feel the benefits of the policy.
As is known to all, the consistency evaluation brings structural adjustment to the generic drug industry, which will break the original market pattern and then reshape it. In short, the enterprises that pass the final test first will redistribute the market space previously occupied by the eliminated pharmaceutical companies and original research manufacturers.
For example, jingxin pharmaceutical co., LTD., which has a strong momentum of consistency evaluation, has three products of ruisuvastatin, zuoethacillin and sertraline hydrochloride accepted by CDE. Among them, risuvastatin belongs to a large variety with wide market space. Whoever can win the position war in the consistency evaluation can seize the market high ground.
Therefore, about 20 enterprises, including zhengda tianqing and baiyunshan pharmaceutical co., LTD., have registered the BE experiment on this variety, but Beijing new pharmaceutical co., LTD., which took the initiative, has submitted it to CDE and has a good chance to pass the consistency evaluation. As a result, astrazeneca, a former research firm, has about 68 per cent of the market and is expected to take a slice of the bargain.
And strong research and development strength, a variety of rich companies will benefit from the improvement of industry concentration in the medium and long term. For example, he now has the largest number of prescriptions, according to the number of drug registrations, which some in the industry have pointed out will give Shanghai pharma a chance to overtake on a curve.
In addition, species such as clopidogrel with clopidogrel and dzhan health with atorvastatin tablets, which have the advantage in consistency evaluation, have a great opportunity to greatly surpass other pharmaceutical companies in terms of policy dividends.
Giving up is not death
There has been talk in the industry that a consistent assessment would kill a large number of drugs. There is some truth in this, but not all of it. Let's be clear, giving up is just another option, not death.
As the rules of the game for consistent evaluation become clearer, the industry has become more aware that the high cost of time and money is not just rhetoric.
On the one hand, the completion of the consistency evaluation will take about 2 years. In the process, the delay caused by additional risk problems will be assumed.
On the other hand, the BE test price of the consistency evaluation has been rapidly increased, with the average level reaching 2 million to 3 million yuan. Combined with the cost of a preliminary pharmaceutical evaluation, the cost of completing a single generic drug consistency assessment would exceed $5 million.
The evaluation cost of generic drug consistency is too high, which will take a long time to recover. From the perspective of input-output ratio, a large number of pharmaceutical companies will give up due to economic problems.
More importantly, according to some statistics, only 43 percent of the drug companies in the "289 catalogue" have less than 10 approvals for a single variety. In other words, there are a lot of competitors on a variety of tracks.
In the face of such fierce competition situation, it is advisable to selectively abandon some varieties and select the ones that contribute more to the strategic development of the company for consistent evaluation.
According to the general administration of the state administration of pharmaceutical administration of China, released in August, the basic information on the consistent evaluation of quality and efficacy of generic drugs in the 289 catalog of enterprises, many of the top varieties have given up on the consistent evaluation.
Among them, the largest number of enterprises holding the document, the number of compound sulfamethoxazole tablets, the number of enterprises giving up the evaluation reached 391. The number of companies abandoning the corresponding varieties of norfloxacin capsules, metronidazole tablets, berberine hydrochloride discs and vitamin B6 tablets was 234, 212, 232 and 187 respectively.
At present, there are still some enterprises that are not sure whether to give up or not. It is believed that over time, more enterprises will see the situation clearly and make decisions.