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生物类似物的研发在过去的十几年,以及在可预见的未来的很长一段时间内,都将是生物制药产业研发的一个热点。作为当前全世界在生物医药产业方面最先进的国家,美国在生物类似物的产业政策方面有着更复杂的考量和利益纠葛。一方面,持续的创新,需要更强有力的市场保护,以保证创新的企业获得高利润,以维持其继续进行高风险的创新药物研发的能力。而其创新的成果,最终会带来科学的进步,健康领域的变革,最终使人类获益。另一方面,创新药物上市初期高高在上的价格,也可能阻碍很大一部分人群获得相关治疗。而生物类似物有望帮助患者以较低的成本获得相对有效的药物,从而可能带来很好的社会效益。因此,平衡鼓励创新和患者利益之间的关键在于设定合理的生物类似物的监管要求和市场准入条件,这将最终确定开发和使用生物类似物是否能造福社会。
The development of bio-analogues will be a hot spot in the biopharmaceutical industry for more than a decade and for a long time in the foreseeable future. As the most advanced country in the biomedical industry in the world at present, the United States has more complicated considerations and conflicts of interest in the industrial policy of bio-analogues. On the one hand, continuous innovation requires stronger market protections to ensure that innovative companies generate high profits in order to sustain their ability to continue research and development of high-risk, innovative drugs. The result of its innovation will eventually bring about scientific progress, changes in the field of health, and ultimately benefit human beings. On the other hand, the high initial price of innovative drugs may also hinder the access of a large proportion of people to treatment. The biological analogues are expected to help patients get relatively effective drugs at lower cost, which may bring good social benefits. Therefore, the key to balancing the need to encourage innovation and patient welfare lies in setting regulatory requirements and market access conditions for sound biological analogues, which will ultimately determine whether the development and use of biological analogues can benefit the community.