The ins and outs of biosimilars & biologics in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75.

1. Are biosimilar medicines considered the same as generic medicines in your country?

No, they are different. On one side biosimilar products are biologically synthesized products which require a much more complex procedure to elaborate due to the fact that bigger molecules are being synthesized (such as growth hormones) while generics have more simple chemical structures and are considered identical to an already existing product.

2. Are all biologic medicines, including biosimilar medicines patentable in your country?

There is no prohibition for the patentability of biosimilar medicines provided they comply with inventive requirements.

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?

Yes, there is a specific regulatory framework for the marketing authorization of biosimilar medicines in Peru, Supreme Decree N° 013-2016-SA, Regulation for the Filing and Content of the Required Documents in the Registration of Biologic Products that Opt for the Similar Way.

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?

Yes, the approval of biosimilar drugs requires the filing of additional documents such as the comparison with the Biological Product of Reference.

5. What are the requirements for the choice of the reference comparator product?

The following requirements must be considered:

1. Registration in Peru or a country of high sanitary surveillance
2. It cannot be a biosimilar
3. The same BPR must be used during the entire process
4. The Pharmaceutical Active Ingredient of the Biosimilar and the BPR must show the similarity.

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

Yes, provided it has been registered for commercialization in a country of high sanitary surveillance.

7. How are the prices of biosimilar medicines regulated? Is this any different to the requirements for the original Biologics drug?

The prices of biosimilars are not regulated.

8. What is the reimbursement policy for biosimilar medicine? Is this any different to the requirements for the original Biologics drug?

Reimbursement policies are determined by the company selling the product and are not regulated.

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

Reimbursement policies are determined by the company selling the product and are not regulated.

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?

There is no special framework for the prescription or dispensing of biosimilars. Consequently, general health laws apply.

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

Yes, it considers physician-led switching and/or pharmacy-level substitution.

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?

The post authorization requirements are not different from Biologic drugs and, being that in both cases, the fabricants and importers must report any suspicions of adverse reactions or events.

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?

Second Use Patents are not allowed in Peru.

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)

There have been no recent developments.

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?

There is no proposal to reform or significantly change the procurement of biosimilars.