Biosimilars & Biologics
AFRA / Panama
The key facts about biosimilars & biologics in Panamanian Pharma. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75.
BIOSIMILARS AND BIOLOGICS in Panama are regulated by Law 1 January 10, 2001, Executive Decree No. 95 of May 14, 2019
1. Are biosimilar medicines considered the same as generic medicines in your country?
No. Generic medicines are defined as medicines distributed or sold that are marked with the generic name of the active principle.
Biosimilar medicines are neither defined nor regulated by Panamanian Law, however, in general terms biosimilar medicines are biologic medical products highly similar to another already approved biological or biotechnological medicine.
Therefore, they are not considered the same, since generic medicines are derived from a pre-existing active principle and biological or biotechnological products must evidence a better or superior effectiveness, quality and safety from the reference product from which they are derived.
2. Are all biologic medicines, including biosimilar medicines patentable in your country?
Biological medicines can be patentable provided that are a new invention, resulting from an inventive activity that is susceptible of industrial application.
3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?
No. Biosimilar medicines are neither defined nor regulated by Panamanian Law.
N/A
4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?
Please refer to Question 3.
5. What are the requirements for the choice of the reference comparator product?
Please refer to Question 3.
6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?
Please refer to Question 3.
7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?
Please refer to Question 3.
8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?
Please refer to Question 3.
9. Does biosimilar competition impact the reimbursement policy of the originator reference products?
Please refer to Question 3.
10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?
Please refer to Question 3.
11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?
Please refer to Question 3.
12. What are the post – authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?
Please refer to Question 3.
13. Are there specific policies and requirements in terms of biosimilar medicines labelling in the event of second medical use patents? Is this any different to the requirements for the original Biologics drug?
Please refer to Question 3.
14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)
No to the best of our knowledge.
15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?
No to the best of our knowledge.
