Qilu Pharmaceutical Andee was approved, and the third member of the domestic biosimilar family was welcomed.
Release time:
2020-01-21 19:50
On December 9, the application for marketing registration of bevacizumab injection (trade name: Anda) developed by Qilu Pharmaceutical Co., Ltd. was approved by the State Drug Administration. This drug is the first domestic product developed and declared to be produced in accordance with the biosimilar drug route with the original research and development of bevacizumab as a reference drug. It is the first domestic approved bevacizumab biosimilar drug, mainly used for advanced, Treatment of patients with metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer.
This means that Qilu Pharmaceutical's blockbuster product, which has lasted nearly 10 years of scientific research, recombinant anti-VEGF humanized monoclonal antibody injection (trade name: Ankeda) is about to enter clinical use, which will improve the accessibility of such drugs and provide a new choice for the treatment of domestic patients.
The original research bevacizumab (Avastin) is a humanized anti-VEGF monoclonal antibody. It is Roche's first anti-angiogenic drug in the world that can be widely used in a variety of tumors. It inhibits tumor angiogenesis by blocking VEGF, cuts off the blood supply to the tumor area, and inhibits tumor growth and metastasis, thus producing anti-tumor effects.
The drug was first approved by FDA in 2004, approved in Europe in 2005, marketed in China in 2010 for the treatment of metastatic colorectal cancer, and approved by NMPA in 2015 for the treatment of non-small cell lung cancer. As of today, approved including colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, fallopian tube cancer, peritoneal cancer and other solid tumor indications. The efficacy and safety of bevacizumab have been confirmed by a large number of clinical studies, and its application in multiple tumor species has been included in many guidelines and diagnosis and treatment standards at home and abroad, and the corresponding levels of recommend are carried out according to the level of clinical research evidence.
As one of the three giants of Roche monoclonal antibody, the drug has dominated the sales list for many years, with global market sales of about 6.849 billion Swiss francs in 2018. Insight sales database shows that domestic bevacizumab sales in 2017 are about 1.5 billion yuan.
The patent protection of bevacizumab in China expires in 2018, and the number of manufacturers participating in the development of such a super-heavy variety is increasing. Apart from the first approved Qilu Pharmaceutical, which was accepted by the Drug Evaluation Center of the State Drug Administration in August 2018, Cinda Biology immediately submitted a listing application in January 2019 and was accepted. At present, a total of 12 enterprises are in clinical phase III, which is regarded as the second echelon; five are in Phase I and are considered to be in the third tier.
The 2017 national health insurance negotiations resulted in a significant reduction in the price of bevacizumab, from $5210 per bottle (100 mg/4 ml) to $1998, greatly improving accessibility. In the future, with the introduction of domestic biosimilars, the pressure on Chinese cancer patients to pay for bevacizumab will be further reduced.
The first domestic bevacizumab biosimilar is the third member of the domestic biosimilar family. Following its approval, three Chinese-made biosimilars have been approved in 2019, all of which are heavyweight products. They are the first domestic rituximab biosimilar from Fuhong Hanlin, the first domestic adalimumab biosimilar from Baiotai Bio, and the first domestic bevacizumab biosimilar from Qilu Pharmaceuticals. This is the major progress and breakthrough made by China's biomedical industry in the field of biosimilar drug research and development in the coming year.
Biosimilar drugs refer to therapeutic biological products that are similar to registered reference drugs in terms of quality, safety and effectiveness. Generally, the listing of biosimilar drugs is considered to help improve the accessibility and reduce the price of biologic drugs, and can better meet the public's demand for biologic therapeutic products.
However, due to high barriers to the development and production of biopharmaceuticals, no domestic biopharmaceuticals have been approved for marketing in China until 2019. In February 2015, China's drug regulatory authorities formulated and issued the Technical Guidelines for the Development and Evaluation of Biosimilar Drugs (Trial). This provides direction for research and development enterprises, and some Chinese pharmaceutical research and development enterprises are rapidly deploying biosimilar drug development.
Until February this year, China's first biosimilar, rituximab biosimilar developed by Fuhong Hanlin, was approved, making the field successfully break the ice. After that, Baiaotai Biology and Qilu Pharmaceutical also won the "first" title of blockbuster bio-similar drugs. It is worth mentioning that, according to the data released by the State Food and Drug Administration of China earlier, China has become the country with the largest number of biosimilar drugs under research. Nearly 200 clinical applications for biosimilar drugs have been approved, and some of the products under research have completed phase 3 clinical trials and submitted applications for listing.
China has made significant progress in the field of biosimilar drug research and development in 2019, which is inseparable from the efforts of a group of Chinese biomedical enterprises and R & D scientists, as well as the support of policies such as encouraging pharmaceutical equipment innovation and encouraging the research and development of biosimilars, as well as the efforts made by China's State Drug Administration in recent years to speed up drug review and approval and solve drug accessibility problems. These drugs will certainly bring new treatment options for patients, and it is hoped that more new drugs and good drugs will play a greater role in the treatment of diseases and human health in the future.
Third, biological, similar, monoclonal antibody, China, research and development, domestic, treatment, listing, clinical
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