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Response to the Editorial "Building a wall against biosimilars" April 2013 Issue of Nature Biotechnology

THOUSAND OAKS, Calif., (Apr. 8, 2013)

Biosimilars can offer additional choices to patients, doctors and pharmacists as well as the potential for increased access and reduced cost. Development and manufacturing of these complex biological medicines is proving to be scientifically challenging and capital intensive. This challenge is intrinsic to the nature of biologics, not a construct imposed through regulatory barriers. We believe biosimilar companies need significant expertise, infrastructure and investment capital to successfully develop and manufacture these molecules, and these are acknowledged areas of strength for the Amgen and Actavis' oncology biosimilar collaboration. Other companies also have the necessary capabilities, and there is nothing inconsistent between maintaining high standards and fostering robust competition.

Regarding regulatory standards, the editorial omits that generics/biosimilar manufacturers were also involved in the consultation process for the European biosimilars pathway. As biosimilars are introduced into the U.S. healthcare system, and continue to grow in Europe, there must be an ongoing and uncompromising commitment to patient safety. As has been the case in the European Union (EU), this starts with science-based and patient-focused regulatory approval standards and ongoing manufacturer accountability.

Actavis and Amgen are committed to ensuring that these complex biosimilar medicines become a reality for patients by supporting science-based regulatory decisions that will ensure biosimilars are a long term and growing therapeutic alternative for patients world-wide.

We therefore support the regulatory authorities' viewpoint in the U.S and EU that pharmacists should not switch one biologic medicine for another without involving the prescribing physician unless –as in the U.S. – there is a regulatory designation that the two biologic medicines are interchangeable with each other. Currently, the U.S. is the only country to formally allow an interchangeable designation for biologic medicines. In the EU for example, the European Medicines Agency does not make recommendations on whether a biosimilar could be used interchangeably with its reference medicine. In its 2012 Q&A document on biosimilars, the Agency directs patients to speak to their doctor and pharmacist on questions related to switching from one biological medicine to another.

Scott Foraker, Vice President and General Manager, Biosiomilars, Amgen
Fred Wilkinson, President, Actavis Specialty Brands (formerly Watson Pharmaceuticals)