Oral solid preparation usually refer to the general term for the preparation of tablets, capsules, granules, etc., after natural medicines are crushed and extracted. This article will briefly introduce the difficulty of evaluating the consistency of generic drugs and the competitive landscape of oral solid preparations.
It is understood that oral solid preparations are difficult to evaluate the consistency of generic drugs, which are mainly reflected in three aspects.
The preparation technology requires high. The era of low-level imitation in the past is gone. For oral solid preparations companies to pass the consistency evaluation, they need higher requirements in the formulation and technology of the preparation.
Medicilon's preparation laboratory and workshop area is about 4,000 square meters, with 100 professional R&D teams, of which more than 40% are masters/doctors, and more than 95% are undergraduates. The team has rich experience in successful research and development of innovative drugs, consistency evaluation, and improved new drugs, and experience in China-US dual filing and project management. The Medicilon pharmaceutical preparation R&D team has successfully cooperated with well-known large and medium-sized pharmaceutical companies worldwide, and has accumulated 18 years of experience in the research and application of innovative drugs and generic drugs. We provide one-stop and systematic preparation R&D services covering innovative drugs and generic drugs to meet the needs of customers at different stages of R&D.
The evaluation cost is high. According to a statistics in the industry, 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 addition, when clinical data is scarce, the varieties to be evaluated are clustered together. The cost of evaluation will increase further.
Time pressure is great. According to the requirements of the relevant documents, after the original 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 granted after the deadline.
At present, as most of the large-scale oral preparations in China have been declared or even passed by many enterprises, the industry judges that the market space for oral solid preparations is relatively small, and the consistency evaluation competition is in a fierce state.
At the same time, the industry believes that the consistency evaluation of injection products may become a new battlefield for generic drug companies to compete in the future. It is expected that the competition after the evaluation will be more moderate, and the risk and return of the first opportunity will be relatively high.
The “Relevant Policies on Encouraging Drug and Medical Device Innovation and Implementing the Full Life Cycle Management of Drugs and Medical Devices (Draft for Comment)” issued in May 2017 mentioned that it will take about 5 to 10 years to basically complete the re-evaluation of marketed injections. Those who pass the re-evaluation can enjoy the relevant policies for the consistency evaluation of the quality and efficacy of the oral solid preparations of chemical generic drugs.
Facing the current policy environment for the consistency evaluation of generic drugs and the trend of domestic drug policy review, some companies have decided to follow an international development strategy after thorough discussion and certification, and invest in the construction of oral solid preparations production bases that comply with European and American cGMP standards.
According to the industry, high-level oral solid preparations products have passed European and American certifications and entered the international market, which will help to further improve international sales and profitability, and also help speed up the review of international to domestic reports.
It is worth noting that, because the construction of the cGMP system requires a large amount of capital and material resources, it also has high requirements on the company’s research and development capabilities, and requires the company to continuously invest in financial and material resources.
At present, domestic companies that have established cGMP certification systems are mainly large-scale enterprises such as Chenxin Pharmaceutical, Huahai Pharmaceutical, Puli Pharmaceutical, Hengrui Pharmaceutical, and Renfu Pharmaceutical.
The author has learned that Renfu Medicine recently issued an announcement stating that the oral solid preparations workshop of the company’s subsidiary Ren Fulikang has passed the U.S. Food and Drug Administration (FDA) certification. The oral solid dosages workshop mainly produces medicines in tablet and hard capsule preparations, with a designed production capacity of 1 billion tablets (tablets) per year. The cumulative investment of RenFulikang in this FDA certification is about 5 million yuan.
According to the company, the FDA certification of RenFulikang oral solid preparations workshop is conducive to the company’s simultaneous application of generic drugs and new drugs in China and the United States, and will have a positive impact on the company’s expansion of international business.
Analysis on the Composition and Preparation Process of Oral Solid Dosage Forms
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