As new pharmaceutical drugs enter the market, they may secure a financially promising disease indication, especially if there are no available treatment options. Their specific formulation, manufacturing standards and proven efficacy eventually then lead to a substantial market share. This is also driven by companies protecting their R&D investments via patents. However, finally, the patents expire, giving rise to generic competitors. According to the same specifications, these drugs are produced and, therefore, have virtually identical safety and efficacy, but by different pharmaceutical manufacturers. This is also true for antibody medicines, which, upon patent expiry, face competition from biosimilars.
By Pavel Ryzhov, Ph.D.
Avastin, a brand name for bevacizumab, produced by Genentech, is a recombinant humanized monoclonal antibody that functions as angiogenesis inhibitor (against human vascular endothelial growth factor). After its initial FDA approval in 2004 for metastatic colon cancer (mCRC) combined with standard chemotherapy, its indication was since expanded to include renal, ovarian, certain lung cancers and others. However, due to patent expiry in the US in 2019 and in the EU set for 2022, it faced competition from biosimilars.
In the recent press-release, 3SBio Inc, a Chinese biopharmaceutical company with a diverse portfolio of product candidates in oncology, and many other diseases, announced that investigational new drug application for SB8, a biosimilar of bevacizumab, collaborating with Samsung Bioepis, has been accepted by the National Medical Products Administration (Chinese agency for regulating drugs and medical devices). The announcement comes on the hills of the marketing authorization for SB8 by the European Commission in August 2020. The authorization allows SB8 to be used across multiple oncology indications, such as mCRC, metastatic breast cancer, non-small cell lung cancer (NSCLC), epithelial ovarian, fallopian tube, primary peritoneal, cervical cancer and advanced/metastatic renal cancer.
The authorization in Europe and acceptance of IND in China come after the Phase III trial’s positive results in 2019. It was a randomized, double-blind, multi-center study that recruited 763 patients with metastatic or recurring non-squamous non-small cell lung cancer. It showed no clinically meaningful differences between SB8 and Avastin when it comes to safety, efficacy, pharmacokinetics and immunogenicity.
3SBio’s biosimilar of bevacizumab is pursuing mCRC and NSCLC as the main indications in China. These indications are due to the somber trends, as reported by Chinese National Cancer Center (CNCC). According to CNCC, in 2015, 376,000 cases of CRC and 191,000 CRC-caused deaths and 733,300 cases of lung cancer and 610,200 deaths were reported in the same year. Predominant lung cancer type was NSCLC, with more than 85% case rate. Concerning bevacizumab’s financial outlook, Frost & Sullivan report projected significant growth of its biosimilars in Chinese market, reaching a market share of RMB 9.9 billion by 2030. In light of the news announcement, Dr. Jing Lou, Chairman of 3SBio also reflected on the company’s position in China and abroad: “3SBio looks forward to accelerating the clinical development of SB8” and “will continue to strengthen its leadership status […] through internal R&D initiatives and strategic collaborations”.
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