Knuts B
J Pharm Belg. 2016 Dec(4):24-29.
Biologicals are omnipresent in the current therapeutic arsenal for treating several chronic and life-threatening diseases. Following expiry of patent, 'generic' versions of biological medicines are being developed, so-called biosimilars. In view of their potential to reduce the continuous economic pressure of biologicals on the healthcare system, the eagerness to introduce them at fast rate as alternative treatment options is huge. For all parties involved (patients, physicians, pharmacists and other healthcare professionals), it is of utmost importance to get acquainted with the features of biosimilars. Biosimilars differ from generic drugs as they are, as a result of a complex production process in living organisms, never 100% chemically identical to the originator drug. However, the stringent regulatory pathway for approval requires similarity to the reference biological medicine in terms of biological activity, safety and efficacy. Knowledge on immunogenicity, interchangeability and substitution is constantly evolving. As more biosimilars - possibly of the same reference biological - will entrance the market, traceability becomes key for an efficient pharmacovigilance system. Pharmacists, in their role to advice and support patients, should be adequately trained and have access to relevant information about all aspects on biosimilars.
生物制品在当前用于治疗多种慢性和危及生命疾病的治疗手段中无处不在。专利到期后，生物药品的“仿制药”版本正在被开发，即所谓的生物类似药。鉴于它们有可能减轻生物制品给医疗保健系统带来的持续经济压力，人们急切希望尽快将其作为替代治疗选择引入。对于所有相关方（患者、医生、药剂师和其他医疗保健专业人员）来说，了解生物类似药的特性至关重要。生物类似药与仿制药不同，由于其在生物体中的复杂生产过程，它们与原研药在化学上永远不会100%相同。然而，严格的批准监管途径要求在生物活性、安全性和有效性方面与参比生物药相似。关于免疫原性、可互换性和替换性的知识也在不断发展。随着更多生物类似药（可能是同一种参比生物药的）进入市场，可追溯性成为高效药物警戒系统的关键。药剂师在为患者提供建议和支持时，应接受充分培训并能够获取有关生物类似药各方面的相关信息。
