yanlev-shutterstock-com-1
YanLev / Shutterstock.com
3 December 2015AmericasGerard Norton and Michael Montgomery

To dance or not to dance: biosimilar strategies post Amgen v Sandoz

The Biologics Price Competition and Innovation Act (BPCIA) is a landmark piece of legislation signed into law by the Obama administration in 2009. The BPCIA provides for a regulatory approval pathway for biosimilar products, which are like generic pharmaceuticals in that they are based on already approved ‘name brand’ biologics.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Americas
15 December 2015   Parties are required to provide 180 days’ notice to a patent owner before marketing a biosimilar version of its drug, a US district court has ruled.
Americas
6 April 2016   The US Food and Drug Administration has approved a biosimilar version of Janssen Biotech’s drug Remicade.

More on this story

Americas
15 December 2015   Parties are required to provide 180 days’ notice to a patent owner before marketing a biosimilar version of its drug, a US district court has ruled.
Americas
6 April 2016   The US Food and Drug Administration has approved a biosimilar version of Janssen Biotech’s drug Remicade.

More on this story

Americas
15 December 2015   Parties are required to provide 180 days’ notice to a patent owner before marketing a biosimilar version of its drug, a US district court has ruled.
Americas
6 April 2016   The US Food and Drug Administration has approved a biosimilar version of Janssen Biotech’s drug Remicade.