* Abasria is first biosimilar insulin to win EU green light
* Copycat medicine seen likely to be launched in mid-2015
* Sanofi hit may be limited as EU market smaller than U.S.
(Adds comment from Lilly, more on competition)
By Ben Hirschler
LONDON, June 27 European regulators have for the
first time recommended approval of a copycat insulin for
diabetics, posing a threat to French drugmaker Sanofi
whose top-selling Lantus is now set to face a cheaper rival in
The new drug, known as Abasria, is made by U.S. rival Eli
Lilly, which has developed it as a so-called biosimilar
version of Sanofi's $8 billion-a-year Lantus, or insulin
The green light from the European Medicine Agency (EMA) for
Lilly and its partner Boehringer Ingelheim marks another step
forward for biosimilar medicines, which are copies of biotech
drugs that promise to cut the cost of treatment.
Biosimilar versions of drugs such as EPO, used to boost red
blood cells, and human growth hormone, for treating certain
growth abnormalities, have been available for several years,
while the first antibody-based biosimilar, for rheumatoid
arthritis, was approved in Europe last September.
The evolution of such medicines represents a long-term
challenge to makers of complex biological drugs, which are given
by injection and have been largely immune to generic competition
up until now.
Industry analysts expect Lilly's version of insulin glargine
to be priced significantly lower than Lantus, in order to
attract patients and healthcare providers.
Enrique Conterno, president of Lilly's diabetes division,
said his company's product would provide "an important new
option for the millions of patients in the EU who need basal
insulin to help manage their diabetes."
Basal insulin is intended to provide long-lasting blood
sugar control between meals and at night. Lantus currently
dominates the market for such products, out-selling a rival
treatment called Levemir from Denmark's Novo Nordisk.
Because biotech drugs are made from living cells it is
impossible to manufacture exact copies, as happens with simple
chemical medicines, so European regulators have devised an
approval process for products that are similar enough to do the
The EMA, which announced its recommendation on Friday at the
end of a monthly meeting of experts in London, said clinical
studies had shown Abasria to have a comparable quality, safety
and efficacy profile to Lantus.
The positive recommendation from the agency's Committee for
Medicinal Products for Human Use (CHMP) will now go to the
European Commission for final approval, but Lilly will not be
able to launch immediately as Sanofi still has patent
With the European compound patent on Lantus set to expire in
May 2015 in most markets, Deutsche Bank analyst Mark Clark said
he expected Lilly to start rolling out the drug for type 1 and
type 2 diabetes from around the middle of next year.
Although a challenge for Sanofi, Clark said the financial
impact of European approval of biosimilar Lantus would be
limited as Europe accounted for only 14 percent of the product's
global sales of 5.7 billion euros ($7.8 billion) last year.
The U.S. market accounts for two-thirds of Lantus sales and
the rules for biosimilars are different there, suggesting no
direct read-across from the EMA decision.
Sanofi is also developing an improved successor to its
long-running cash cow. This follow-on, Toujeo, could also be
ready for launch in mid-2015 and Sanofi is expected to work hard
to shift patients on to the new medicine.
The EMA said a pharmacovigilance plan would be implemented
for Lilly's product as part of its marketing authorisation.
Lilly's drug was previously known as LY2963016.
($1 = 0.7359 Euros)
(Editing by Kate Kelland, Sophie Hares and Pravin Char)