Institut multidisciplinaire d'oncologie, Clinique de Genolier, CH-1272 Genolier, Switzerland.
Target Oncol. 2012 Mar;7 Suppl 1:S51-5. doi: 10.1007/s11523-011-0193-6. Epub 2012 Jan 19.
Until recently, prescribers had to deal with generics, considered to be simple molecules that are easy to copy. But as discussed in this paper, the biodisponibility of generics remains a source of uncertainty. And now there are biosimilars, limited for the time being in the cancer setting to granulocyte-colony stimulating factors (G-CSFs) and epoetins. Soon there will be biosimilar monoclonal antibodies with anticancer activity. Prescribers will ask, as they did for generics, if such drugs have the same activity as originators, if their safety profile is the same, if quality of the production process is guaranteed. Prescribers will want to know if their patients are indeed receiving the prescribed product, and not another. Finally prescribers will want to check that the lower cost of biosimilars will allow them to adhere to international guidelines. This should benefit patients and the community.
直到最近,医生还不得不处理仿制药,这些药物被认为是易于复制的简单分子。但正如本文所讨论的,仿制药的生物利用度仍然是一个不确定的来源。现在有生物类似药,目前仅限于癌症领域的粒细胞集落刺激因子(G-CSF)和促红细胞生成素。很快就会有具有抗癌活性的生物类似单克隆抗体。医生会像对待仿制药一样询问,这些药物是否与原研药具有相同的活性,其安全性是否相同,生产过程的质量是否有保证。医生希望知道他们的患者是否确实使用了处方药物,而不是其他药物。最后,医生还会检查生物类似药的较低价格是否能使他们遵守国际指南。这将使患者和社会受益。