In the bio-similar drug market, who is in charge of the Chinese and foreign scuffle?

Biosimilar drugs (Biosimilar) are undoubtedly a hot spot in the global pharmaceutical field in recent years. Although compared with chemical generic drugs, both technical requirements and investment costs are much higher, they still attract the attention of numerous Chinese and foreign pharmaceutical companies because of their bright prospects.

Novartis alone Glatopa this product. Since its launch in 15 years, it has already achieved sales of US $0.142 billion. Based on its current sales situation, it is expected that sales will reach US $0.262 billion by the end of this year. And Novartis's four-drug portfolio is expected to exceed $1 billion in sales.

At the same time, Pfizer invested in the construction of the first biotechnology center in Asia in Hangzhou in June this year. Based on this base, it will not only shorten the approval time of its biosimilar drugs in China, but also reduce the cost of logistics and other costs, so as to obtain a larger market.

On the other hand, major domestic pharmaceutical companies have also seen the great potential of biosimilar drugs and have joined the ranks of R & D and sales. The recent clinical trial of Ranibizumab (Ranibizumab) was approved by Qilu Pharmaceuticals, which is suitable for the treatment of "wet" age-old macular degeneration.

Jiahe Bio has just received clinical approval for bevacizumab (Bevacizumab), which is mainly indicated for metastatic colorectal cancer and non-small cell lung cancer. Another number of enterprises at the same time to obtain or declare the variety of clinical trials. Adalimumab (Adalimumab), the star product of biosimilar drugs, is preferred by more enterprises. It has been approved for eight indications worldwide, including adult moderate to severe active rheumatoid arthritis and severe active ankylosing spondylitis.

According to the current Thomson Reuters data, my country's preclinical research drugs rank first in the world, and the number of core patents ranks third in the world, second only to the United States and the European Union. Areas of interest focus on cancer, diabetes, and the immune system. As a result, many drugs are imitated by many companies at the same time, while others are unattended, which not only causes a waste of resources, but also is not conducive to the effective growth of the biosimilar drug market.

In addition, although China has issued the trial document of "technical guiding principles for research and development and evaluation of biosimilar drugs" in February 2015, the specific standards and relevant rules for evaluation have not yet been issued. At present, the approval process of biosimilar drugs still follows the approval of new drugs for biological products, and still faces the problem of complex and time-consuming approval procedures.

At the same time, technical difficulties and high investment costs also limit the progress of biosimies. The patent issue is even more of a problem that biosimilar drugs can't get around, and the problems surrounding patents of biosimilar drugs and original drugs are hindering the listing of biosimilar drugs. In the United States, for example, the FDA has approved four biosimilar drugs, but only one has been successfully marketed. Patent barriers severely limit biosimilar.

In any case, the future of biosimilars remains bright. Rejection IMS Health predicts that by 2020, the annual sales of biosimilars will reach 25 billion US dollars, accounting for 10% of the total biopharmaceutical market share. And in the next five years, a large number of blockbuster biopharmaceutical patent protections have expired or are about to expire, and biosimilars will capture 20% of the global pharmaceutical market. It is hoped that Chinese enterprises can seize the opportunity, give full play to the market advantage, seize the opportunity, and stand out in the fierce competition.

News source:http://www.y-lp.com/pages/Article.aspx?id=4877992744286549370

This news was re-edited and reorganized by the Huaxun team and added analytical comments.