Amgen US Biosimilars Policy
Experience that can’t be replicated
When the Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010, creating the biosimilars approval pathway, Amgen embraced the opportunity to extend our mission to serve patients. We recognized that biosimilars would become an important part of broadening patient and physician options for biologic treatments and foresaw that our expertise in developing and manufacturing biologics also would apply to biosimilars.
Today, we remain fully committed to the success of the biosimilars market and to our portfolio of 10 biosimilars in development (two of which already have received FDA approval)*, which target serious diseases. Amgen is unique in the biosimilars space in that we have a 40-year heritage of discovering and developing novel biologic medicines. This experience gives us valuable insight into what is needed for biosimilars and originator biologics to succeed for patients, physicians, and payers.
*As of December 31, 2018.
Building a robust and sustainable market through science-based policies
To achieve the promised savings in the US health care system from biosimilars, we need to advance science-based policies that instill physician and patient confidence, create a level playing field for reimbursement, and foster biosimilar competition.
Amgen believes that to create and grow a robust and sustainable biosimilars marketplace over the long term:
- Regulators must maintain scientifically appropriate development standards for biosimilarity and interchangeability that will instill physician and patient confidence, while ensuring patient safety and efficacy
- Robust competition on a level playing field must be established with respect to reimbursement to achieve lower costs in a manner that builds stability over the long term
- Policies must support both innovation in biological products and widespread acceptance of biosimilars
- Science-based education for stakeholders is needed to promote uptake and proper use
- FDA Biosimilars Action Plan
- Amgen’s Comment to the FDA Biosimilars Action Plan
- FDA Patient and Prescriber Outreach Materials
- Circle the Suffix Campaign
Biologics prescribers collaborative:
- Physician Survey Findings on Current Interchangeability Standards
- Physician Confidence Is Cornerstone to Biosimilars Success
National conference of state legislatures:
Amgen in the News
Note: a subscription may be required for some of the following links:
- Morning Consult: A Level Playing Field for Biosimilar Success December 18, 2018
- BioWorld: Interchangeability Not in the Driver’s Seat for Biosimilars November 19, 2018
- Financial Times: Rivals Line Up to Take on World’s Best-Selling Drug October 14, 2018
- Pink Sheet: Biosimilar Bridging Study Waivers: Public Health Prerogative or Trade Secret ‘Taking’? September 10, 2018
- Scrip: From Interchangeability to Exclusivity: US FDA Looks for Ways to Make Biologics Market More Competitive, Sue Sutter September 7, 2018
- S&P Global Market Intelligence: Drugmakers, Public Weigh in on Efforts to Boost US Biosimilar Competition, Donna Young September 4, 2018
- Regulatory Focus: Companies Discuss Biosimilars, Suggest Reforms at FDA Public Meeting, September 4, 2018