(Adds background, details on study, shares)
Nov 29 U.S. biotech Momenta Pharmaceuticals Inc
said on Tuesday its experimental biosimilar version of
AbbVie Inc's top-selling autoimmune drug, Humira, met
the main goal in a late-stage trial involving patients with a
form of psoriasis.
Humira, considered the world's biggest-selling medicine,
generates $15 billion in annual sales and treats rheumatoid
arthritis, Crohn's disease and psoriasis, among other
Biologics including Humira are manufactured in living cells,
then extracted and purified. As they are more complex than
traditional medicines and cannot be copied with precision, their
knock-off versions are called biosimilars, rather than generics.
Several companies are developing biosimilar versions of
top-selling biotech medicines for rheumatoid arthritis and
In September, Amgen Inc's Humira biosimilar was
approved by the U.S. Food and Drug Administration - the first
one to win U.S. regulatory nod for the drug. But AbbVie is
trying to block its launch, contending that Humira's patents
should protect it until at least 2022.
In Momenta's trial, adult patients with moderate-to-severe
chronic plaque psoriasis received up to 48 weeks of treatment
with Momenta's drug, called M923, Humira itself, or Humira
alternating with M923.
The percentage of patients that achieved at least a 75
percent reduction on an index of psoriasis severity was
equivalent between M923 and Humira, meeting the main goal of the
Momenta developed M923 in collaboration with Baxalta - which
is now part of Shire Plc - but in September, Shire
decided to end its biosimilars program, and is in the process of
transitioning the drug to Momenta.
Momenta's shares were up 7.9 percent at $15.00 in premarket
trading on Tuesday.
(Reporting by Natalie Grover in Bengaluru; Editing by Sai