Bill Overview
Title: Interchangeable Biologics Clarity Act
Description: This bill provides a statutory definition for first interchangeable biosimilar biological product and makes other technical changes with respect to the provisions that establish the corresponding periods of market exclusivity.
Sponsors: Sen. Kaine, Tim [D-VA]
Target Audience
Population: People reliant on biologic medical treatments
Estimated Size: 30000000
- Biological products are medical products such as vaccines, blood, or blood components, gene therapies, tissues, and recombinant therapeutic proteins.
- Biosimilars are biological products that are highly similar to an FDA-approved reference product, with no clinically meaningful differences.
- Health professionals and pharmacies are directly involved in prescribing and dispensing biosimilars and will be impacted by clarity in regulations.
- Patients who require treatments that involve biologics will be affected by changes in market exclusivity which can influence the availability and cost of these products.
- Pharmaceutical companies that manufacture biologic and biosimilar products will be impacted by regulations affecting market exclusivity.
Reasoning
- The policy is expected to primarily affect individuals who rely on biologic treatments, health professionals, and pharmaceutical companies.
- Patients reliant on biologic treatments, especially for chronic conditions like diabetes and cancer, may experience changes in drug prices and availability.
- Healthcare professionals, including doctors and pharmacists, are likely to see changes in prescribing patterns and potentially reduced drug costs, impacting their practice operations.
- The pharmaceutical industry may experience adjustments in market strategies due to altered exclusivity periods, impacting their finances and drug development plans.
Simulated Interviews
Rheumatologist (Houston, TX)
Age: 58 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- I welcome the clarity the policy brings. It could make biologics more affordable and accessible, which is crucial for my patients.
- Market exclusivity issues have been a barrier to prescribing more cost-effective biosimilars.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 8 |
Biotechnology Researcher (Los Angeles, CA)
Age: 36 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- This policy is critical for the biotech field. It allows for more innovation and competition, which can lower healthcare costs.
- Clarified regulations help us plan product development schedules better.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 7 |
Retired teacher (Miami, FL)
Age: 67 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- I hope this leads to lower prices for my medication. It’s hard to keep up with the cost on a fixed income.
- Access and affordability are major concerns for people like me.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Pharmacist (Chicago, IL)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This regulatory clarity is a step forward for pharmacists. It helps us ensure we are complying with laws while offering the best meds to patients.
- Biosimilars being more accessible can lead to cost savings for our hospital.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 7 |
Oncologist (Columbus, OH)
Age: 52 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- I'm optimistic that this policy will help my patients get the treatments they need at a more reasonable cost.
- Exclusivity has been a challenge in getting affordable biosimilars.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 9 | 7 |
Healthcare Policy Analyst (New York, NY)
Age: 29 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- This will likely encourage more biosimilars into the market, which is favorable for healthcare systems.
- Keeping an eye on pharma responses to these changes is crucial.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Patient Advocate (Nashville, TN)
Age: 40 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 5/20
Statement of Opinion:
- The policy might improve drug access for patients, which is fundamental.
- Market exclusivity has often prevented the introduction of more affordable options.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 8 | 7 |
Biopharmaceutical Executive (San Francisco, CA)
Age: 32 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 3.0 years
Commonness: 3/20
Statement of Opinion:
- The policy provides clearer paths for product approvals and market entry.
- We anticipate more competition, but this can drive innovation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 8 | 8 |
Chronic Illness Patient (Seattle, WA)
Age: 50 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 12.0 years
Commonness: 4/20
Statement of Opinion:
- I hope this policy leads to more affordable treatment options.
- Clarity is essential to help track what drugs will be available and when.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Pharmaceutical Sales Representative (Atlanta, GA)
Age: 61 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 7.0 years
Commonness: 3/20
Statement of Opinion:
- Policy shifts might impact our sales strategies, but clearer regulations can be beneficial.
- Educating clients about new options is an ongoing challenge that might ease.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Cost Estimates
Year 1: $5000000 (Low: $3000000, High: $7000000)
Year 2: $4000000 (Low: $2000000, High: $6000000)
Year 3: $3000000 (Low: $1000000, High: $5000000)
Year 5: $2000000 (Low: $1000000, High: $4000000)
Year 10: $1000000 (Low: $500000, High: $2000000)
Year 100: $1000000 (Low: $500000, High: $2000000)
Key Considerations
- The policy primarily affects market clarity and regulatory compliance, with no direct monetary cost burden on significant government spending programs.
- The main impacts will revolve around indirect savings from increased competition and reduced drug prices over time.
- Regulatory adjustments may take time to implement and fully integrate into the existing framework, causing initial transitional expenses for industry stakeholders.