摘要：Biosimilars, also known as follow on biologics, are complex biotechnology drugs that are similar, but not identical, to original biologic drug forms, and represent potential lower cost versions that may improve access. Yet biologics and their biosimilar forms have a key safety concern: unwanted immunogenicity. Emerging markets have tremendous interest in biosimilars, but are at a tipping point: they are moving from developing country concerns (e.g., communicable disease) to developed country needs (e.g., cancer therapies) that require biologic drugs. Production, however, is at lower than current Good Manufacturing Practice levels standard in highly-regulated markets. Emerging market public-private partnerships between public agencies, local producers, and global pharmaceutical firms, can incentivize biosimilar production at higher quality levels than required for local markets as well as position themselves for entry into developed markets. Public health goals can be reached while increasing economic opportunities in these markets to benefit global health.
关键词：emerging markets;biosimilars;follow-on biologics;immunogenicity;patient safety;public-private partnerships;global health
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