“It’s not like these companies are bitter enemies,” Zuercher Kantonalbank analyst Michael Nawrath says. “These court cases are simply the last resort of original drug makers to wring a few more months or a year of exclusivity from their blockbusters.”
Conflicts pitting big drug makers against each other may have been inevitable after Europe in 2006 and the United States in 2010 created separate biosimilar approval rules.
After all, Big Pharma’s financial clout and expertise made large, sophisticated drug makers the natural candidates to manufacture complex biosimilar copies that cost hundreds of millions to bring to market, far more than for generic off-patent copies of simpler, small molecule drugs.
Some smaller companies and generics makers have jettisoned biosimilar programs after originally underestimating hurdles to entry, Richard Francis, head of Novartis’s Sandoz division that makes biosimilars, said earlier this year.
Just this week, Shire abandoned two biosimilar candidate drugs that accompanied its Baxalta takeover, copies of Amgen’s Enbrel and AbbVie’s Humira (adalimumab), to focus on rare diseases.
“The realisation of what it’s going to take to stay in this market and be successful has led to a change in the landscape and the players in it,” Francis says.