Brazil: The Brazilian Ministry Of Health Announces Its Preliminary Review Of PDP Projects For MABs And Etanercept

Last Updated: 26 October 2017
Article by Licks Attorneys

Once again, the Ministry of Health (MoH) changes the market share of PDPs involving monoclonal antibodies and etanercept.

The MoH made its announcement through Ordinance #1992, published in the Official Register on August 4, 2017. It contained the result of the MoH's preliminary review of the PDP projects involving monoclonal antibodies (adalimumab, bevacizumab, infliximab, rituximab and trastuzumab) and etanercept.

The review conducted by the MoH took into consideration the last market share allocation related to these products, announced through its Ordinance #542 of 2017 on July 14, 2017 (for more information regarding this allocation, please check our client alert here).

The table below contains a summary of the result of the MoH's review, indicating which projects or approved or rejected. For the approved projects, it also indicates their market share of the non-commercial public market of those products. For the first time the MoH has been clear on which public institution (Biomanguinhos, Butantan and Tecpar) has partnered with which company (Bionovis, Libbs, Orygen/Pfizer and Axis Biotech):

Products Biomanguinhos
+
Bionovis
Butantan
+
Libbs
Tecpar
+
Orygen/Pfizer
Tecpar
+
Axis Biotech
Adalimumab 40% 10% 30%
Bevacizumab 25% 25% 50%
Etanercept 60% 20%
Infliximab 50% 50%
Rituximab 50% 30% 20%
Trastuzumab 40% 20% 40%

Comparing Ordinance #1,992's market share allocations with Ordinance #542's, one can note that the Brazilian company Cristalia was taken out of all its PDP projects (trastuzumab and etanercept). For instance, apparently its 40% market share previous allocated to Tecpar's PDP project was transferred to Axio Biotech. Likewise, the Russian drug manufacturer Biocad also lost the 25% market share of its PDP project for bevacizumab. A table summarizing the evolution of the market share allocation of PDP projects related to MABs and etanercept is can be downloaded here.

Nevertheless, this is not a definitive result. Further changes are still possible especially in view of article 2 nd of Ordinance #1,992, which requires public institutions to submit to the MoH the necessary amendments in their PDP Projects. The public institutions have a 30 day-term, starting from the day that the MoH's formal communication is received, to submit their amended PDP projects. It's not clear tough, if said changes refer only to companies` replacement or if it refers to other changes not disclosed by the MoH.

Finally, Ordinance #1,992 provides that the new proposals of PDP projects can be submitted aiming the remaining non-allocated market share. The problem is that Ordinance #1,992 is not clear if a new term will be opened for interested parties to submit their proposals.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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