By Se Young Lee
Samsung Bioepis Co Ltd, which aims to become a force in the fledgling biosimilar drugs industry, has filed a lawsuit against the originator of the world's best-selling drug, to stop it blocking the launch of its own version.
The unit of South Korea's Samsung Group, along with partner and minority shareholder Biogen, filed suit in Britain on March 24 against AbbVie Inc, maker of rheumatoid arthritis drug Humira, which generated sales of US$14 billion (NZ$25.25 billion) in 2015.
It is the company's first suit against a drug originator.
Interest in biosimilars - lower-cost copies of complex biotech drugs - has soared in recent years as copies of some of the world's best-selling prescription medicines have hit the market.
Unlike generic versions of simple chemical medicines, biotech drugs are made from living cells, so it is impossible to manufacture exact copies.
The IMS Institute for Healthcare Informatics says biosimilars could save healthcare systems in the United States and Europe's top five markets as much as 98 billion euros (NZ$161.57 billion) by 2020.
The South Korean conglomerate hopes for big things from the unit - including a revenue target of one trillion won (NZ$1.22) by 2020 - amid sagging profits at its electronics business, Samsung Electronics, the world's biggest maker of smartphones and televisions.
Success in the endeavour is seen as key for de facto Samsung Group leader Jay Y Lee, 47, to prove himself as steward of the family-run smartphones-to-insurance empire. His father, group patriarch Lee Kun-hee, has been hospitalised since a 2014 heart attack.
The composition patent for Humira lost its exclusivity in the US in December 2016, and loses it in Europe in October 2018, but Illinois-based AbbVie, which earned 61 percent of its 2015 net revenue from Humira, has been filing new patents in a bid to push back sales of biosimilars.
In addition to Samsung Bioepis and Biogen, more than a dozen firms have challenged AbbVie's strategy through patent authorities or the courts.
"We believe that AbbVie has been attempting to obstruct market entry of competing products by applying for a large number of overlapping patents around Humira, which could affect patient access to affordable medication," Samsung Bioepis told Reuters.
"We believe competition should take place in the market, and not through such misuse of the patent system," it added.
AbbVie told Reuters it was aware of the lawsuit filed by Samsung Bioepis and Biogen.
"As we have said, we intend to defend our intellectual property," it said.
Samsung Bioepis, which brought its first drug to market in late 2015, has a pipeline of 13 biosimilars, versions of existing drugs with similar efficacy at much lower prices, and is initially focusing on six of them to get out in front of the market.
The Samsung Group has a track record of moving fast. Late to enter the smartphone market, Samsung Electronics quickly rose to become the industry leader. The group is also one of the world's most active patent filers and has over the years tried to move beyond its image as a "fast follower".
"The first drug to hit the market takes the most market share, so this is the right strategy to go with," said Kang Yang-ku, analyst at HMC Investment & Securities.
There are potentially rich pickings for early movers; more than 10 blockbuster biological drugs with combined yearly sales of $US60 billion (NZ$86.78billion) are on track to see their US and European patents expire over the next four years, according to Allied Market Research.
Biosimilars are a source of consternation for investors in firms such as AbbVie, however, as the cheaper copies threaten to undercut profits for the original drug makers.
In December, Bioepis began selling a biosimilar of Amgen's arthritis drug Enbrel in South Korea, and the drug has since launched in some European markets including Germany and Britain in early 2016. The European Medicines Agency also has recommended the Bioepis copy of another blockbuster drug Remicade for approval in Europe.
Samsung Bioepis is 91 percent-owned by Samsung Biologics, which manufactures biological drugs and is in turn mostly owned by Samsung C&T Corp and Samsung Electronics.