How Much Do You Know About Biosimilar Exclusivity and Approval?

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Questions and Answers

What is the minimum amount of notice a biosimilar applicant must provide before commercial marketing?

120-day notice

90-day notice

180-day notice (correct)

240-day notice

What is the maximum amount of time that Supplementary Protection Certificates (SPCs) can add to a pharmaceutical product's patent-based exclusivity?

15 years

10 years

20 years

5 years (correct)

What is market exclusivity?

Confidential information provided to a regulatory authority for obtaining regulatory approval.

The right to block or delay the launch of equivalent competitor products, even without patent protection.

The period of time a pharmaceutical product can be sold without competition.

The exclusive right to market a product granted to the recipient of the first regulatory approval. (correct)

When does the Regulatory Data Protection (RDP) period start for a pharmaceutical product in the EU/EEA?

At the time of marketing authorization Signup and view all the answers

How long does the US FDA grant exclusivity for a pharmaceutical product containing a previously unapproved active moiety?

5 years Signup and view all the answers

How long does a biosimilar exclusivity period last for the first biosimilar product?

12 months Signup and view all the answers

What is the purpose of the two-year period that follows the Regulatory Data Protection (RDP) period for a pharmaceutical product?

To allow for generic competitors to enter the market Signup and view all the answers

What is the waiting period for subsequent biosimilars after the first biosimilar has been approved?

18 months Signup and view all the answers

How long is the market exclusivity period provided for pharmaceuticals that treat diseases affecting fewer than 200,000 individuals in the US?

7 years Signup and view all the answers

What is data exclusivity?

Confidential information provided to a regulatory authority for obtaining regulatory approval. Signup and view all the answers

How long is the data exclusivity period provided by the European Medicines Agency (EMA)?

8 years Signup and view all the answers

How long is the market exclusivity period provided by the European Medicines Agency (EMA)?

10 years Signup and view all the answers

How can the cumulative 10-year period of market protection be extended by 1 year?

By obtaining a new indication that provides additional clinical benefit over previous indications. Signup and view all the answers

What is the duration of the re-examination period in Japan?

4-6 years Signup and view all the answers

Does Australia provide market exclusivity protection?

No, it does not provide any market exclusivity protection. Signup and view all the answers

What happens if the confidentiality of the information associated with data exclusivity is not maintained?

The exclusivity period is reduced Signup and view all the answers

Study Notes

FDA may approve biosimilar if reference product's market exclusivity has expired.
Biosimilar applicant provides 180-day notice before commercial marketing.
Brand owner may seek preliminary injunction to prohibit biosimilar manufacture or sale.
Biosimilar can be launched while litigation proceeds if preliminary injunction is not granted.
Biosimilar applicant may still be liable for pre-launch infringing activities.
Biosimilar exclusivity grants 12-months of exclusivity to the first biosimilar product.
Interchangeable biologic exclusivity grants 12-months of exclusivity to the first interchangeable biologic product.
BPCIA provides an additional exclusivity period of up to 12 months.
Subsequent biosimilar must wait 18 months after approval of the first biosimilar.
Settlement agreements can be used to share the exclusivity period.

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Description

Test your knowledge on Biosimilar Exclusivity with this informative quiz! Learn about the FDA approval process, the role of the biosimilar applicant and brand owner, and the various exclusivity periods granted under the BPCIA. Discover the intricacies of launching a biosimilar product and find out how settlement agreements can impact exclusivity periods. This quiz is perfect for those looking to deepen their understanding of biosimilar exclusivity and the legal landscape surrounding it.