Alvotech公司宣布,已重新向美国食品药品监督管理局提交了其生物类似药产品Avt05与Avt06的生物制品许可申请。
Avt05是参照原研药Simponi®及Simponi Aria®开发的生物类似药候选产品。而Avt06则是参照原研药Eylea®开发的生物类似药候选产品。
此次重新提交申请,标志着该公司在推动这些重要生物类似药于美国市场上市的过程中迈出了关键一步。
Alvotech公司宣布,已重新向美国食品药品监督管理局提交了其生物类似药产品Avt05与Avt06的生物制品许可申请。
Avt05是参照原研药Simponi®及Simponi Aria®开发的生物类似药候选产品。而Avt06则是参照原研药Eylea®开发的生物类似药候选产品。
此次重新提交申请,标志着该公司在推动这些重要生物类似药于美国市场上市的过程中迈出了关键一步。
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