Posted by Michael Wonder on 14 Jul 2016
Gormley’s take: road to launching ‘biosimilar’ drugs just got longer
13 July 2016 - Small companies developing lower-cost copies of expensive biotechnology drugs already faced a tough road launching their products. A new court ruling could make that journey even tougher, and longer.
Biotech drugs such as proteins and antibodies draw billions of dollars in sales for companies like AbbVie Inc., the maker of Humira, a $14 billion product that treats rheumatoid arthritis and other autoimmune diseases. Patents are now expiring on many biotech drugs, including the main one on Humira, which lapses in December.
Until recently, U.S. biotech companies didn’t have to worry about generic competition. Biotech drugs are made in living cells and, unlike conventional drugs, they can’t be copied exactly. That changed with the federal health-care law in 2010, which created a pathway for close copies of biological drugs, or “biosimilars,” to earn FDA approval.
