(Repeats Oct 2 story with no changes to text)
* Drugmakers protect own medicines while challenging rivals
* Drugmakers' last resort to wring exclusivity from
* Novartis CEO predicts biosimilar discounts of up to 75 pct
By John Miller
ZURICH, Oct 2 The line dividing makers of
brand-name drugs and copycat medicines is blurring as companies
known for innovative treatments queue up to peddle copies of
rivals' complex biological medicines.
These drugmakers are now increasingly straddling both sides
of the courtroom, too, protecting their high-price products from
biosimilars - biopharmaceutical drugs with the treatment
properties of medicines they seek to mimic - while
simultaneously challenging rivals' patent claims.
Biologics, manufactured in living cells, then extracted and
purified, are more complex than traditional medicines and cannot
be copied with precision, and so their knock-off versions are
called biosimilars instead of generics.
The allure of biosimilars is clear, with insurers and other
payers counting on the steep discounts. U.S. pharmacy benefit
managers are already trimming brand-name drugs from their
With Novartis Chief Executive Joe Jimenez
predicting biosimilar discounts of up to 75 percent, in part
based on developments in Europe, makers of innovative drugs are
fighting tooth and nail to protect their higher-priced products
for as long as possible. [
For instance, AbbVie has sued in Delaware claiming
patent protection for its arthritis drug Humira, the world's
best-selling prescription medicine, until at least 2022 as it
seeks to delay an Amgen replica that won U.S. approval last
Meanwhile, Amgen has gone to another U.S. federal court
seeking to protect its own arthritis medicine, Enbrel, from a
Novartis biosimilar until 2029.
With lawsuits pitting Big Pharma against Big Pharma piling
up, lawyers said the legal landscape has gotten a lot more
"One of the biggest surprises has been the number of
innovator biopharma companies, like Amgen, now developing
biosimilars to compete with the products of other innovator
companies," said Don Ware, an expert on biosimilars at U.S. law
firm Foley Hoag in Boston.
"This creates conflicts for law firms like ours, because
suddenly the clients we advise are adverse to each other," Ware
said. "And it makes it hard for the companies to retain top
outside counsel without having to give them conflict waivers."
Sanofi, Merck, Eli Lilly, Pfizer
, Johnson & Johnson and Biogen are also
embroiled in lawsuits over biosimilars.
For a Factbox on major suits see:
NOT BITTER ENEMIES
Even so, some analysts say the lawsuits are business as
usual and are unlikely to spill over into other areas, including
Novartis and Amgen may be at each other's throats in court
over the Swiss drugmaker's Enbrel copy, but the two are still
cooperating on a drug for migraines.
"It's not like these companies are bitter enemies," Zuercher
Kantonalbank analyst Michael Nawrath said. "These court cases
are simply the last resort of original drug makers to wring a
few more months or a year of exclusivity from their
Conflicts pitting big drugmakers against each other may have
been inevitable after Europe in 2006 and the United States in
2010 created separate biosimilar approval rules.
After all, Big Pharma's financial clout and expertise made
large, sophisticated drugmakers the natural candidates to
manufacture complex biosimilar copies that cost hundreds of
millions to bring to market, far more than for generic
off-patent copies of simpler, small molecule drugs.
Some smaller companies and generics makers have jettisoned
biosimilar programmes after originally underestimating hurdles
to entry, Richard Francis, head of Novartis's Sandoz division
that makes biosimilars, said earlier this year.
Just this week, Shire abandoned two biosimilar
candidate drugs that accompanied its Baxalta takeover, copies of
Amgen's Enbrel and AbbVie's Humira, to focus on rare diseases.
"The realisation of what it's going to take to stay in this
market and be successful has led to a change in the landscape
and the players in it," Francis said.
($1 = 0.9699 Swiss francs)