NOVARTIS Sandoz wants the US
Supreme Court to reconsider the
ruling that biosimilar makers have
to wait an extra six months after
Food and Drug Administration
(FDA) approval before the product
can be launched on the market.
Sandoz’s Zarxio drug which
came to the market as a biosimilar
version of Amgen’s Neupogen
(fligrastim) is at the centre of the
appeal.
The FDA approved Zarxio in
Mar 2015 but it didn’t come to
the market until Sep because of
the ruling on a provision in the
Biologics Price Competition and
Innovation Act.
Sandoz claims in its petition it
provided Amgen with more than
180 days’ notice (minimum period
of notification) of its intent to put
the drug on the market.The above article was sent to subscribers in Pharmacy Daily's issue from 22 Feb 16 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 22 Feb 16
IN WESTERN Australia, Michael’s Chemist Group has started stocking therapeutic Nicotine Vaping Products (NVPs), pursuant to the Federal Government’s new vaping laws (PD 25 Mar).
FREE Pharmacy Daily subscription - never miss another story!
to top
Subscribe to Pharmacy Daily
Pharmacy Daily subscription confirmation
Thank you for signing up! Check your email inbox – you should shortly receive a message with a link which must be clicked to confirm your subscription.
Once you’ve done that you will begin receiving Pharmacy Daily as soon as the next issue is published.