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Biological similar drugs will be the next gold mine
Market potential is limitless
From 2011 to 2017, it was another peak period for the patent of trademark drugs in the history of the world pharmaceutical industry. Some large multinational pharmaceutical companies have expired more than half of the $77 billion of drug patents in succession, and the new medical reform in the United States will consume about 1 trillion dollars in the next 10 years. These two figures all stimulate the sensitive God of pharmaceutical companies. The classics. However, limited to the new drug research and development technology and the first imitation of the country's first imitation policy, although the pharmaceutical market is wide, the related enterprises are still difficult to successfully drink "generic drug sweet soup".
With the insight into the market predicament of the generic drugs, more and more pharmaceutical companies are now turning their attention to the market of biosimilars. In addition to Zarxio, Johnson (Remicade, 2013 global sales of US $8 billion 400 million), SB2 (Remicade), SB3 (Herceptin), SB4 (Enbrel), SB5 (Humira), MK-1293 (Lantus)), 100 time American Shi Guibao and other powerful foreign companies, China CITIC health and Beida Huahai, Hai Zheng, Heng Rui, Li Zhu, Ren Fu, Hua Lan and a number of local enterprises with bio pharmaceutical development capabilities are also making efforts in the market of bio similar drugs.
For many pharmaceutical companies to exert themselves in the market of biological analogues, they are related to the encouragement of relevant policies.
Take China as an example, in February 28, 2015, the CFDA Drug Evaluation Center (CDE) issued the guiding principles for the development and evaluation of biological analogues (Trial). The regulatory framework for biopharmaceutical drugs has been identified, which provides another way for biopharmaceuticals to be listed in China. Similar to the regulatory authorities in the United States and the European Union, CDE also hopes that pharmaceutical companies will submit detailed structural and functional properties of similar drugs in order to compare with the reference drugs. In addition, CDE has adopted a gradual approach similar to that in developed countries by comparing pharmacological data, non clinical studies and clinical studies to evaluate similarities.
Similarly, a draft guide to labelling of similar products was issued in FDA2016 March 31st. In the draft guide, FDA clearly pointed out that biological similar product labels should not include a description of clinical studies that only support the evidence of similar products and reference products for the discrepancy of approved indications without clinical significance.
The promulgation of relevant policies of various countries has undoubtedly brought confidence to a large number of pharmaceutical enterprises to enter the market of bio similar drugs.
In fact, the reality is expected to go to pharmaceutical companies with similar drug markets. According to the latest data, the market for biological similar drugs will reach $110 billion by the year 2020 only in Europe and the United States. With the expiration of the patent drug, in the next 5 years, biological similar drugs will seize 20% of the market, and it is expected that the price difference between the related brand biologics and biological generic drugs will be further promoted.
Technology restricts the development of enterprises
Although the prospect of biological analogues is good at present, the industry also reminds that its future faces many challenges and risks.
One is that similar drugs are facing the market. Such as the resistance of the biological original research drug enterprises. In December 2015, Amgen announced that it would submit bio products licensing application (BLA) to biosimilars ABP501 to FDA. In fact, the drug is biosimilars for Miller's super heavy drug repair Miller (Humira, generic name: adalimumab). The move is interpreted by the industry as "Ai Ai patent war", which has a great impact on the market.
The two is that the technical advantage needs to be upgraded. According to the statistics, from the field of treatment, even the largest share of immune stimulations and diabetes, high technical content of biological products is very few, or a low technical content of biochemical drugs as the dominant. According to the product category, the polypeptide and synthetic insulin, which occupy the largest share, are low - tech products, and the high - tech biodrugs such as mAb are very limited. Therefore, biotechnology related technologies have solved or decided the future development path of pharmaceutical enterprises.
The three is that the price advantage is not obvious. The characteristics of biologic drugs determine that the cost of development and production is much higher than that of chemical generic drugs. According to the related reports, the degree of its profit depends mainly on the supervision of the policy, but it is difficult to occupy the market with low price strategy in the mainstream market of Europe and America.