So far Abbott Laboratories ($ABT) is having to fly solo in its challenge to the legality of the biosimilar provision in the Affordable Healthcare Act.
In a citizens petition filed with the FDA in April, the biologicsmaker claimed that its rheumatoid arthritis drug Humira cannot be copied because it would be illegal to require Abbott to cough up the trade secrets that it has spent "massive amounts of money" to develop, The Wall Street Journal reports. Further, it contends that no biologic drug approved before passage of the law should be considered for biosimilar approval.
There has been plenty of opposition from those groups that want to see consumers benefit from cheaper biologic drugs coming to market sooner and are concerned the challenge will hold up a new market for biosimilars. There also has been a dismissal of the effort by Hospira ($HSP), which is in line to be a major biosimilar manufacturer. But as the WSJ points out, there has been no support from the other biologics companies, or even trade groups. Even the Biotech Industry Organization (BIO), which this week concluded its annual meeting, has expressed support for the law. Of course its members include drug companies who benefit on both sides of biologics.
"We continue to believe that the biosimilars law applies, and should apply, to all biological products, whether the reference product was approved pre- or post enactment of the law," BIO said in a statement.
There is no secret as to why Abbott must try to protect Humira. It was the company's top-selling drug last year with about $3.4 billion in revenue. EvaluatePharma predicts that Humira will be the No. 1 selling drug this year with sales reaching an astounding $9.3 billion.
Still, some of the strategy for the challenge may be positioning with investors ahead of its planned pharma company spinoff of AbbVie later this year. According to documents filed for that, Humira will account for 45% of the new company's sales and perhaps 85% of its profit, the WSJ reports. In those documents, Abbott pointed out that sales could be affected by biosimilars. The patent on Humira expires in December 2016, so that kind of competition would be a real drag on a new company that draws most of its profits from a single drug that faces generic competition.
- here's the Wall Street Journal story