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 Novartis's Sandoz generics unit aims to be selling eight biosimilars,
compared with three now, as patents on original drugs expire.
Sandoz head Richard Francis said his versions of AbbVie's $13
billion blockbuster Humira, Amgen's Enbrel and Neulasta, Johnson &
Johnson's Remicade and Roche's Rituxan would arrive in pharmacies
over the next four years, barring stumbles.
The five original drugs booked $44 billion in annual sales in 2015,
combined.
Francis is wagering biotech copies that work like their forerunners
despite slight variations - no biologic drug can be exactly
duplicated - will be irresistible for insurers, health care systems
and governments aiming to contain costs.
"We think we can become a real partner for payers and health care
systems in making sure they can manage their budgets," Francis said
in an interview at his new 150 million euro ($169 million) facility
in Austria's Tyrolia region.
Again and again, governments are rebelling against the cost of
medicines.
Francis's factory, with its white-washed clean rooms, towering
freezers, robots, conveyors and 100 green jumper-clad workers, was
erected to fill 18,000 syringes per hour, 10 million per year.
He has room to expand, too.
"Biosimilars are not something you dip your toe into," Francis said.
"We're full on into it."
His boss, Novartis Chief Executive Joe Jimenez, predicts biosimilars
may cost 75 percent less than the drugs they mimic, a deeper
discount than originally expected.
What he loses on price, however, Jimenez aims to make up in volume.
According to consultancy IMS Health, cheaper biosimilars will save
health systems in the United States and European Union between 50
billion and 100 billion euros by 2020 - especially as doctors
overcome reservations about copies.
Convincing physicians remains a work in progress, said Sandoz
biopharma development head Marc McCamish. When many U.S. doctors
hear regulatory terms like "highly similar", he said, what they hear
is "different".
'CONSTANT FIGHT'
“Those are terms we constantly have to fight,” McCamish said.
Biosimilars arrived in Europe a decade ago, though their American
introduction dragged until last year, when Novartis's Zarxio, a copy
of Amgen's Neupogen drug to fight infection risk in cancer patients,
became the first U.S. Food and Drug Administration (FDA) approval
after a protracted court fight.
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On Sandoz launches through 2020, biosimilars head Carol Lynch
declined to give her specific launch schedule, or say which would be
first. That is partly in regulators' hands, she said, with at least
eight biosimilars including from other companies awaiting the FDA's
green light.
"Right now, there is a delay for many files," Lynch said.
While the European Medicines Agency has approved more than 20
biosimilar drugs including three from Novartis since 2006, the FDA
has approved just two: Zarxio last September and more recently,
Celltrion's version of Remicade for autoimmune diseases.
Beyond regulatory hang-ups, Novartis's 2020 aspirations are also
exposed to lingering legal hurdles, though the company is optimistic
those will be resolved.
In one case, Novartis has petitioned the U.S. Supreme Court to
reconsider a lower court ruling forcing biosimilar makers to wait
six months after FDA approval before starting sales.
"We expect to hear about that over the course of the summer," Lynch
said.
Original drugmakers are extending their elbows. As the main patent
on arthritis treatment Humira, the world's best-selling drug,
expires in December, AbbVie has warned imitators it believes
additional patents protect it until 2022.
($1 = 0.6989 pounds)
($1 = 0.8866 euros)
(Editing by Mark Potter)
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