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Response to Letter from Dr. Jorge Revilla Beltri dated 22nd March, 2013
VALUE IN HEALTH REGIONAL ISSUES 2 (2013) 333
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/vhri
Response to Letter from Dr. Jorge Revilla Beltri dated 22nd March, 2013 The letter from Dr. Revilla Beltri, a Medical Director at Probiomed, raises two points. First, that we cited a newspaper article interview with a source who appears to have been an industry lawyer. On this basis, we withdraw the paragraph in question. Second, Dr. Revilla Beltri states that there are inaccuracies in the published article with regard to the Mexican regulatory framework surrounding biosimilars. We stand by our assertion in the article that a new regulatory pathway had only been recently created in Mexico to reflect the increasing number of biosimilars coming into that market and at the time the article was submitted for publication, that regulatory pathway was still evolving. In fact, the October 2011 Decreto referenced in Dr. Revilla Beltri’s letter specifies that biosimilar regulation in
Mexico should be addressed by a subcommittee on a caseby-case basis but did not specify the regulatory structure that would surround such subcommittees. The second regulation quoted by Dr. Revilla Beltri was enacted after our article was accepted for publication.
Erik Sandorff, MA, MBA PriceSpective, Blue Bell, PA, USA Copyright & 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. http://dx.doi.org/10.1016/j.vhri.2013.05.005
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/vhri
Response to Letter from Dr. Jorge Revilla Beltri dated 22nd March, 2013 The letter from Dr. Revilla Beltri, a Medical Director at Probiomed, raises two points. First, that we cited a newspaper article interview with a source who appears to have been an industry lawyer. On this basis, we withdraw the paragraph in question. Second, Dr. Revilla Beltri states that there are inaccuracies in the published article with regard to the Mexican regulatory framework surrounding biosimilars. We stand by our assertion in the article that a new regulatory pathway had only been recently created in Mexico to reflect the increasing number of biosimilars coming into that market and at the time the article was submitted for publication, that regulatory pathway was still evolving. In fact, the October 2011 Decreto referenced in Dr. Revilla Beltri’s letter specifies that biosimilar regulation in
Mexico should be addressed by a subcommittee on a caseby-case basis but did not specify the regulatory structure that would surround such subcommittees. The second regulation quoted by Dr. Revilla Beltri was enacted after our article was accepted for publication.
Erik Sandorff, MA, MBA PriceSpective, Blue Bell, PA, USA Copyright & 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. http://dx.doi.org/10.1016/j.vhri.2013.05.005