The market for Humira is a large one: the med raked in $11.02 billion last year to top the list of the world's best-selling drugs. So it's no surprise that biosimilar developers are going after a piece of that market--including Amgen ($AMGN), which released some head-to-head data last week that could help it make its regulatory case.
Without laying out any actual data, the California biotech last week announced a win in the first of two planned Phase III trials comparing its Humira biosimilar--ABP 501--with the megablockbuster. Its version hit its efficacy and safety equivalency targets as a treatment for plaque psoriasis, R&D head Sean Harper said in a statement.
The results bode well for Amgen, which will likely have to compete with a slew of new psoriasis therapies by the time Humira loses U.S. patent protection in 2016. Eli Lilly ($LLY) and Novartis ($NVS) have both topped Pfizer ($PFE) and Amgen's star treatment Enbrel in Phase III studies, and Celgene's ($CELG) oral apremilast has an FDA decision date set for September. Amgen and AstraZeneca ($AZN) trail behind it with an IL-17A inhibitor, brodalumab, that put up impressive Phase III results in May--and the list goes on.
Of course, Humira is approved for more than just psoriasis. The chart-topper boasts indications in a range of other diseases, including rheumatoid arthritis, Crohn's disease and ulcerative colitis. But Amgen isn't alone in the race to bring a copy to market. Novartis' Sandoz unit embarked on Phase III trials for its knockoff last December, and Boehringer Ingelheim and Virginia-based Coherus Biosciences are working on their own versions, too.
As PMLiVE notes, however, Amgen's biologics know-how and marketing muscle could help it outdo those competitors in the marketplace and grab a slice of the pie from AbbVie ($ABBV). All told, analysts expect biosimilars to take a 20% to 30% chunk out of biologics sales.
While that's nothing like the generics take-down Big Pharma has suffered lately as top small-molecule drugs hit the patent cliff, it's still a sizeable sales hit for a company like Illinois-based AbbVie. Spun off from Abbott Laboratories early last year, the company generated 57% of its 2013 sales through its star drug, and a recent effort to diversify its product lineup--a $54 billion deal for Ireland's Shire ($SHPG)--may now be in jeopardy thanks to a U.S. crackdown on tax inversions.
Still, AbbVie may have more time to gear up for the biosimilars hit. In Europe, where biosimilar versions of other meds are already on the market, Humira has an extra two years of patent protection. And with all the unknowns surrounding their U.S. launch, Novartis CEO Joe Jimenez doesn't expect biosims to make much of an impact until around 2020.
It'll take about that long for companies to navigate regulatory hurdles and costs, and for doctors and patients to get comfortable with the idea, Jimenez figures. Despite his own company in July becoming first to file a biosimilar application with the FDA, "I think in two to three years you're not going to see a big difference," he told Reuters in August.
- read the release
- get more from PMLiVE
- read FierceBiotech's take
Special Report: The 10 best-selling drugs of 2013 - Humira