View Exam | PowerPak

1. The Biologics Price Competition and Innovation Act of 2009 was enacted to:

A. Provide a pathway for biosimilars, thus increasing competition with biological medications B. Decrease price and increase access to biological medications C. Provide an incentive for manufacturers to develop new and innovative treatments D. All of the above

2. According to the FDA draft guidance on biosimilars, which of the following serves as the “foundation” for the stepwise approach towards demonstrating biosimilarity?

A. Studies evaluating structure and function B. Human pharmacokinetics and pharmacodynamics studies C. Clinical safety and effectiveness D. Post-marketing studies, including pharmacovigilance

3. The regulatory requirements for approval of biosimilars “are stringent and require thorough evaluation of safety and efficacy.” However, the process is abbreviated compared to innovator products and the pool of patients and clinical data is smaller.The integration of biosimilars into the US market is based off of the European experience; which of the following therapies have shown the largest biosimilar integration into Europe?

A. Human Growth Hormone B. Epoetin C. G-CSF D. Infliximab

4. Which of the following measures will help address outcomes with integration in both the US and European markets?

A. Extrapolation B. Pharmacovigilance C. Interchangeability D. Immunogenicity

5. The PLANETRA and PLANETAS studies showed which of the following outcomes?

A. Similar infection rates among both study arms B. Greater immunogenicity profiles between the reference product arm and the biosimilar CT-P13 in the PLANETAS Study C. No statistically significant differences in clinical responses between both the reference product arm and the study arm D. All of the above E. A and C

Evaluation Questions

6. This educational activity included faculty speakers who were knowledgeable and engaging:

A. Agree B. Disagree

Maintenance is scheduled for 5/15/2024 5:00 PM EST - 5/16/2024 5:00 AM EST.

{{recommendationsA.Title}}

{{recommendationsB.Title}}

1. The Biologics Price Competition and Innovation Act of 2009 was enacted to:

2. According to the FDA draft guidance on biosimilars, which of the following serves as the “foundation” for the stepwise approach towards demonstrating biosimilarity?

4. Which of the following measures will help address outcomes with integration in both the US and European markets?

5. The PLANETRA and PLANETAS studies showed which of the following outcomes?

Evaluation Questions

6. This educational activity included faculty speakers who were knowledgeable and engaging:

« Return to Activity

Maintenance is scheduled for 5/15/2024 5:00 PM EST - 5/16/2024 5:00 AM EST.

The shopping cart is empty

Customers who Purchasedthis Activity also Purchased

{{recommendationsA.Title}}

{{recommendationsB.Title}}

1. The Biologics Price Competition and Innovation Act of 2009 was enacted to:

2. According to the FDA draft guidance on biosimilars, which of the following serves as the “foundation” for the stepwise approach towards demonstrating biosimilarity?

4. Which of the following measures will help address outcomes with integration in both the US and European markets?

5. The PLANETRA and PLANETAS studies showed which of the following outcomes?

Evaluation Questions

6. This educational activity included faculty speakers who were knowledgeable and engaging:

« Return to Activity

Customers who Purchased
this Activity also Purchased