Health Canada consulting on new biosimilar guidance document
Health Canada has published a draft amended guidance document covering information and submission requirements for biosimilar biologic drugs. If implemented, Health Canada...Read More
FDA’s biosimilar stakeholder submission roundup – Part IV
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the...Read More
FDA’s biosimilar stakeholder submission roundup – Part III
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the...Read More
FDA’s biosimilar stakeholder submission roundup – Part II
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the...Read More
FDA’s biosimilar stakeholder submission roundup – Part I
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the...Read More