Cloning: It’s not what you think – Changes to ANVISA’s “clone” procedure

Recently, ANVISA made changes to its simplified procedure for the approval, post-approval and renewal of generic drugs, branded copies of “similar” drugs, specific, dynamised (namely, homeopathic) and herbal drugs and biological products.  Specifically, on May 30, 2014, ANVISA’s Board of Director’s Rule #31 (Rule) was published in the Brazilian Federal Gazette.  The Rule revised ANVISA’s simplified procedure for the approval, post-approval and renewal of generic drugs, branded copies of “similar” drugs, specific, dynamised and herbal drugs and, for the first time, biological products, linked to technical and clinical reports of a “mother” application.  This simplified procedure is referred to as a “clone” procedure.

Under this procedure, a primary “clone” application for a “clone” drug is filed with ANVISA.  A “primary clone application” is a simplified application that is linked to the technical and clinical reports of a mother application (namely, a reference or “mother” drug).  The clone drug may only differ from the reference drug in brand name, packaging layout and in the wording of the package insert and labeling. The clone drug must be of the same dose, form and presentation as the reference drug.  A primary mother application is an application containing all the information necessary for the request for approval of a reference drug.  A primary mother application that has been amended is a “supplemental” mother application.

A key requirement of the clone procedure is that the primary clone application and any amendment to such an application (an amended primary clone application is referred to as “supplemental” clone applications) be filed electronically on ANVISA’s website.  Approval of a clone application is based on the analysis of the following:

1.  Receipt of payment of the necessary administrative fees;

2.  Forms FP1 and PF2 (available on ANVISA’s website);

3.  A declaration of linkage to the mother application, pursuant to Annex I (Annex I is a form submitted by both the mother and the copy requesting marketing authorization for the copy under the cloning procedure;

4.  Package insert wording;

5.  Package layout; and

6.  The drug name and differential supplement (a differential supplement is supplementary designation of a tradename of a drug used to distinguish the drug from another drug previously approved with the same name and from the same company), when applicable, to the category of drug.

Other important considerations under the Rule include the following:

1.  The owner of the mother application must authorize the use of its data in a clone application.

2.  ANVISA is required to issue the same decision (namely, issue an approval) in a clone application as in a mother application if the clone application satisfies the requirements of items 1-6 discussed above.

3.  In the event a mother application has not yet been approved by ANVISA, then ANVISA is required to examine both a mother application and the clone application simultaneously.

The Rule provides a number of benefits both for the clone and mother applicants.  For example, partners in Productive Development Partnerships (PDPs) are able to receive marketing authorization for a clone drug very quickly, such as in few days compared to months or years under traditional pathway. This time savings is significant, particularly for biologics.  Additionally, in patent infringement litigation, if a Patentee can demonstrate that a mother drug infringes one or more patents, every clone drug would also be considered to be infringing the patent(s) as well. In such an instance, a Patentee would have an easier time obtaining an injunction.

This post was written by Lisa Mueller of Michael Best & Friedrich LLP and Roberto Rodrigues of Licks Advogados.

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