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Biopharm Development & Manufacturing on biologics by the Brazilian government. Recently, the government Surprisingly, once approved, biosimilars are legally interchangeaided creation of two joint public/private partnerships (PPP); Bionovis able and substitutable with their branded biologic counterparts (Ache, EMS, Hypermarcas, and Chemical Union) and Orygen (Biolab, that also have received Russian regulatory approval. Eurofarma, Cristália, and Libbs). Brazil has heavily invested in PPPs as The approval of Russian biosimilars without clinical testing has a means to help the country improve its biotechnology and biomanuraised safety concerns. This has been complicated by the fact that the facturing capabilities and reduce its reliance on high-priced, foreign Russian government is legally required to accept the lowest tendered branded biologics. While the Brazilian biosimilar market continues to expand and remains attractive, safety concerns persist, and many Brazilian healthcare professionals are not familiar with biosimilars or their use. Further, the Brazilian healthcare market is difficult A better way to a better outcome. to navigate, and foreign biosimilar companies will have a challenging time doing business in Brazil unless they partner with domestic biotechnology companies or the Brazilian government. Generic Pharma 2.0's Wolf offered, "Brazil is a vibrant and unique market opportunity. However, if the appropriate relationships are not established TM locally, then commercial success can be elusive." GUESS WHO JUST HAD AN AMRI SMARTSOURCING MOMENT? RUSSIA Russia is an emerging pharmaceutical market with a 2011 market size of roughly $25 billion. Moreover, the size of the 2012 Russian generics market was estimated to be $3.5 billion, making it one of the fastest-growing generic drug markets in the world. Finally, according to Roman Ivanoff, VP R&D; at Biocad, a Russian biosimilar manufacturer, the size of Russia's 2012 biologics market was almost $2.1 billion. Like many other emerging countries in the world, Russia's reliance on high-priced foreign biologics is growing and is causing an enormous financial strain on the country's nationalized healthcare system. Because of this, "The Russian government is very open to discussions about substituting lower-cost biosimilars for high-value biologics," offered Ivanoff. At present, Russia lacks a clearly defined regulatory framework for the approval of biosimilars, which has created some confusion among domestic and foreign biosimilar developers. Interestingly, despite the lack of a defined regulatory approval process, biosimilar versions of EPO and G-CSF are currently commercially available in Russia. "Prior to 2010, there were no clear requirements for clinical trials for biosimilars. So, there are biosimilars on the Russian market today that were approved without clinical trials," explained Ivanoff. "I was worried about our supply chain. AMRI can manufacture the starting materials at a competitive cost to ensure the reliable delivery of the API they make for our new drug. The AMRI SMARTSOURCINGTM strategy lets me sleep better at night." Global Headquarters: 26 Corporate Circle, Albany, New York, USA 12203 T: 1.518.512.2345 | E: james.grabowski@amriglobal.com | www.amriglobal.com www.amrismartsourcing.com | July 2013 linkedin.com/company/amri | @amriglobal LifeScienceLeader.com 29