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Domestic biosimilars expected to be approved in 2020

Release date: 2020-01-06 Views: 0

Source: Medical Rubik's Cube

Since the State Food and Drug Administration formulated and issued the "Technical Guiding Principles for the Development and Evaluation of Biosimilar Drugs (Trial)" in February 2015, four domestic biosimilar drugs have been approved for marketing, including rituximab (Fuxhong Han Lin), adalimumab (Biotec), adalimumab (Hisense Pharmaceuticals), and bevacizumab (Qilu Pharmaceutical).

The PharmaGo database of PharmaGo shows that in addition to the four companies approved above, there are currently many domestic companies with multiple biosimilar drugs that have already been declared for marketing or are in phase III clinical stage, and some of them are expected to be approved in 2020.

Declaration of domestic biosimilar drugs in the market and in phase III

Rituximab

Rituximab is a human-mouse chimeric anti-CD20 monoclonal antibody developed by Roche. It is mainly used for hematological tumors such as non-Hodgkin's lymphoma and chronic lymphocytic leukemia and rheumatoid immune diseases such as rheumatoid arthritis. The drug entered China in 2000 under the trade name Merlot. In 2017, Merlot's global sales amounted to CHF 7.388 billion.

On February 25, Fuhong Hanlin's rituximab has been approved for sale under the trade name Hanlican, and the domestic bid price was 1,640 yuan.

Cinda Bio has submitted an application for listing on 2019/7/1 and has been included in the priority review. It is expected to be approved in mid-2020. In addition, there are many companies such as Shenzhou Cell, Hisun Pharmaceutical, Hualan Biological and other companies in the phase III clinical stage.

Bevacizumab

Bevacizumab is a recombinant humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody, which can be applied to the treatment of a variety of malignant tumors. The original researcher Roche, which was approved in China in 2010 under the trade name Avidin. In 2018, Anvitin's global sales were 6.849 billion Swiss francs, and sales in the Chinese market exceeded 2 billion yuan.

Roche bevacizumab has been included in the national medical insurance category B catalogue in 2017. The medical insurance payment standard is 1998 yuan / bottle. In 2019, the medical insurance negotiation was successfully renewed, and the payment price was kept confidential. On December 9, Qilu Pharmaceutical's bevacizumab biosimilar was approved for marketing in China under the trade name Ankada. At present, Ankda has already launched a network in Shandong, and the planned net price is 1266 yuan / bottle. Cinda Bio has submitted an application for listing on 2019/1/31 and has been included in the priority review. It is expected to be approved in 2020.

Bevacizumab belongs to the anti-tumor angiogenesis mechanism. It is the most widely used "wanjinyou" variety in clinical treatment of tumors. It can be used in combination with other chemotherapy, targeted drugs or immunotherapy drugs in many types of tumors. There is a very wide market space. It can also be found from the previous table that bevacizumab is the most biosimilar drug variety developed by manufacturers.

In terms of progress, after Qilu and Cinda, Dongying Pharmaceutical is likely to become the third company to apply for listing. The drug clinical trial registration and information disclosure platform shows that Dongying Pharmaceutical has recruited Phase III clinical trials for this product. Completed, also disclosed in its prospectus before listing, and the drug is expected to be launched from the end of 2020 to 2021.

Adalimumab

Adalimumab is the world's first fully humanized anti-TNF-α drug developed by AbbVie. The drug was first approved by the FDA in 2002, and entered China in 2010 under the trade name Xiumele. At present, four indications have been approved in China: rheumatoid arthritis, ankylosing spondylitis, moderate to severe chronic plaque psoriasis, and polyarticular juvenile idiopathic arthritis. In September of this year, Xiu Mei Le was included in the 2019 medical insurance category B catalog, and the medical insurance payment standard was 1,290 yuan / piece, limiting the first three indications mentioned above.

At present, two adalimumab biosimilars have been approved for marketing in China, including Biothai and Hisun Pharmaceutical, but the pricing has not been announced. Manufacturers that submitted listing applications include Cinda Bio, Fuhong Hanlin, and Junshi Bio. Among them, the first two have been included in the priority review and are expected to be approved in 2020. Manufacturers in the phase III clinical stage include Chia Tai Tianqing, Divine Cell and Tonghua Dongbao.

Trastuzumab

Trastuzumab is an anti-Her2 monoclonal antibody developed by Roche. It is mainly used in Her2-positive metastatic breast cancer clinically. The drug was approved for marketing in China in 2002 under the trade name Herceptin. Herceptin sales in 2018 were 6.982 billion Swiss francs. In 2017, Herceptin was included in the national medical insurance category B list through negotiation, and the price paid by medical insurance was 7,600 yuan / bottle. The medical insurance negotiations in 2019 have also been successfully renewed, and the payment price is confidential.

Domestically, Fuhong Hanlin has submitted its trastuzumab biosimilar drug marketing application on April 29, 2019, and has been included in the priority review. Companies in the Phase III clinical stage include Hisun Pharmaceutical, Jiahe Bio and Anke Bio.

Etanercept

Etanercept is the world's first TNF inhibitor for rheumatoid arthritis and ankylosing spondylitis. The original research company is Amgen and Pfizer. The drug was approved for marketing in China as early as 2010. Enbrel. In 2018, Enbrel sales reached $ 7.1 billion. The development of generic etanercept in China was earlier, and Sansai Guojian's Yisaipu was approved for listing as early as 2005. After that, similar products from Shanghai Saijin Biotech and Hisun Pharmaceutical Co., Ltd. were launched in 2011 and Approved for listing in 2015. In the strictest sense, however, these products are not considered biosimilars. Qilu Pharmaceutical submitted an application for the marketing of etanercept biosimilar on May 21, 2019, which is expected to be approved for marketing in 2020.

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