According to industry sources, multinational pharmaceutical companies are hindering the growth of the global biosimilar market by using their patents.
AbbVie’s Humira has been the best-selling medicine in the world for years and the American pharmaceutical company recorded US$16 billion in sales last year with this item alone. Key U.S. patents related to this medicine expired in December last year and three biosimilar products based on it have been approved by the U.S. and European health authorities, including Samsung Bioepis’ Imraldi. Still, no Humira biosimilar is currently available in the U.S. and European markets. This is because AbbVie is blocking the release of such products by means of more than 100 related patents and patent lawsuits.
“At present, AbbVie is demanding exclusive sales rights valid until 2022,” said an industry source, adding, “According to legal experts, the first Humira biosimilar is likely to become available in the market in 2022 at the earliest in view of the company’s well-organized defense.”
Amgen, in the meantime, has yet to set the date of release of Mvasi despite the U.S. FDA’s recent approval of the anti-cancer biosimilar. This is for fear of litigation. The U.S. patents related to Avastin, on which it is based, are scheduled to expire in 2019.
Amgen obtained the FDA approval for its Humira biosimilar Amgevita late last year, but had to put off the release of the medicine indefinitely due to a lawsuit filed by AbbVie. More recently, AbbVie filed a suit against Boehringer Ingelheim late last month, claiming that it infringed upon 74 patents with regard to its Humira biosimilar Cyltezo.
Under the circumstances, only three out of the seven biosimilar products that have been approved by the U.S. FDA are currently available in the U.S. market.
Experts point out that the South Korean government’s role is critical for South Korean companies such as Samsung Bioepis and Celltrion to maintain their dominance in the global biosimilar market. The two companies have obtained about 10 approvals in the global biosimilar market and this number is equivalent to approximately 30% of the global total. This implies they can maintain their dominance in the market once they formulate successful patent strategies.