Bill Overview
Title: Biologics Competition Act of 2022
Description: 2022 This bill requires the Food and Drug Administration (FDA) to evaluate (1) the differences between the requirements that apply to interchangeable biologics and the requirements that apply to therapeutically equivalent ratings for generic drugs, and (2) the effects of these differences on the approval of interchangeable biologics. The FDA must update the Purple Book with changes that better align the ways these requirements are communicated while still maintaining each distinct approval pathway. The Purple Book is an FDA publication that lists approved biological products, including biosimilars and interchangeable biologics. Interchangeable biologics are biologics that may be substituted for the original product without consulting the prescriber, similar to how generic drugs may be substituted for brand-name drugs based on therapeutic equivalence.
Sponsors: Rep. Miller-Meeks, Mariannette [R-IA-2]
Target Audience
Population: patients using biologics, healthcare providers, and pharmaceutical stakeholders
Estimated Size: 25000000
- The bill primarily targets the biologics market which includes manufacturers of biologic drugs and biosimilars.
- Patients who use biologics for treatment, as this may eventually affect competition and availability of interchangeable biologics.
- Healthcare providers and pharmacists may be impacted due to changes in regulations around biologics' interchangeability.
- Changes in the Purple Book may affect how biologic treatments are chosen and administered.
Reasoning
- The policy impacts are likely to be felt by manufacturers of biologics, patients who require these treatments, healthcare providers, and pharmacists.
- The population affected by the policy is substantial in size given the prevalence of biologic treatments for conditions such as cancer and autoimmune diseases.
- Only a portion of the $5,000,000 year 1 budget will directly influence patients and providers initially, as much of the effort would be administrative or research-focused.
- The simulated interviews will cover a mix of people: directly impacted (patients, healthcare providers) and those less impacted (general population) to capture a range of perspectives.
- Wellbeing scores are assessed based on policy's impact on affordability, accessibility, and ease of prescribing biologics.
Simulated Interviews
Oncologist (New York, NY)
Age: 57 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- I always want what’s best for my patients, and more competition in biologics could lower costs.
- There's a learning curve when it comes to understanding which biosimilars are truly interchangeable.
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 | 8 | 6 |
| Year 20 | 7 | 5 |
Retired (Phoenix, AZ)
Age: 65 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- I'm hopeful that this policy might make my treatment more affordable in the future.
- Having cheaper alternatives to brand-name drugs would ease my financial burden.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 4 |
Pharmacist (Chicago, IL)
Age: 42 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 8/20
Statement of Opinion:
- It'd be great to have more biosimilar options for our patients.
- Clearer guidelines on interchangeability can simplify our work and improve patient outcomes.
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 | 9 | 7 |
| Year 10 | 9 | 6 |
| Year 20 | 8 | 6 |
Biotech Engineer (Boston, MA)
Age: 28 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Aligning requirements might make it easier to get our products to market.
- I am excited about the potential for this to level the playing field.
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 | 10 | 8 |
| Year 20 | 9 | 7 |
Patient Advocate (Cleveland, OH)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- I see this as a positive step towards broader access for patients.
- There will be logistical challenges at first, but the outcome should be beneficial.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
Primary Care Physician (Seattle, WA)
Age: 34 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- The more options we have for biologics, the better for treatment strategies.
- Patients often ask me about cost-effective alternatives, so this policy is welcomed.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
Insurance Analyst (Miami, FL)
Age: 40 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- I believe this will reduce insurance costs over time if more interchangeable biologics become available.
- The immediate impact on premiums might not be noticeable, but long-term savings are possible.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 5 |
Health Economist (San Francisco, CA)
Age: 38 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- This policy is a step towards reducing healthcare costs overall.
- It will create more research opportunities and shape future drug policy.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Patient with multiple sclerosis (Houston, TX)
Age: 60 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- There's always anxiety about treatment costs rising, so more options mean more peace of mind.
- We need these treatments to live fuller lives, and any help is important.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 4 |
Public Health Official (Atlanta, GA)
Age: 48 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- This alignment is needed to keep pace with drug developments and ensure public health safety.
- I'm optimistic that this creates a more efficient healthcare system.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 6 |
Cost Estimates
Year 1: $5000000 (Low: $4000000, High: $6000000)
Year 2: $4500000 (Low: $3500000, High: $5500000)
Year 3: $4500000 (Low: $3500000, High: $5500000)
Year 5: $3000000 (Low: $2500000, High: $3500000)
Year 10: $3000000 (Low: $2500000, High: $3500000)
Year 100: $3000000 (Low: $2500000, High: $3500000)
Key Considerations
- The impact on pricing for biologic treatments due to increased biosimilar competition.
- Administrative burden on FDA for additional evaluations and updates necessary under the bill.
- Long-term changes in the market dynamics for biologics leading to potential savings.