Coalition for Safe and Innovative Medicine

The Coalition for Safe and Innovative Medicine
was founded to work toward creating a process for review and approval of safe and effective follow-on versions of revolutionary biologic medicine that:

• Maintains the current high scientific standards to ensure patient safety
• Preserves incentives for innovation; and
• Lowers consumer costs

We believe that the current high standards of clinical testing must be maintained for life-altering biologic drugs. Congress should create a process for approval of new follow-on biologics that lowers consumer costs while ensuring patient safety and preserving incentives for innovation.

We support legislation currently being considered by Congress that would establish a safe and secure process for developing less expensive versions of complex biologic drugs.

We oppose a legislative approach that would lower standards of patient safety and undermine confidence in this life-saving field of new medicines by not ensuring these drugs are independently tested for safety and efficacy.

• Overview of the bills
• Pathway for Biosimilars Act
• S. 1505 and H.R. 1956 details
• H.R. 1038 details
• Difference between biologics and drugs
• The complexities of making follow-on biologics
• Safety concerns
• The European Model

Read recent articles about follow-on biologics in the news. This issue is getting more and more coverage; stay tuned to read the latest news here.

Join us on this important issue. You can become an individual member or an organizational member.