Introduction
Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy and safety outcomes similar to the originator biologic.1
在全球范围内，积极发展中的生物仿制性的数量从2011年的大约70岁到2016年大约290岁，阶段1和23％的候选人中大约16％的候选人。3.截至2016年9月，大约197个生物仿制物在全球范围内发动，其中23例用于治疗类风湿性关节炎（RA）。3.RA is the most active indication within the biosimilar pipeline.3.As of May 2017, there were approximately 27 planned/ongoing Phase 1-3 biosimilar RA studies.4.AbbVie’s Humira (adalimumab) is the lead reference biologic with the highest number of biosimilar candidates (27 in global development – preclinical through to Phase III trials), as of September 2016.5.
As a consequence of regulatory authorities in some emerging markets having a less rigorous approval pathway for “biosimilars” (i.e. not requiring head to head data that compares their product to the innovator/reference biologic) and thus not meeting the rigorous requirements of established bodies (e.g. US, EU, WHO, etc.) for demonstrating “biosimilarity,” a large number of “similar biologics” are already on the market in some developing countries ‒ by August 2016 India had approved more than 60 “similar biologics”.5.
Key Issues for Study Recruitment
As competition for RA patients increases with new, innovative RA therapies in development and an increasing number of RA studies being conducted to assess the efficacy and safety of biosimilar agents, it is becoming more difficult to identify sufficient top tier sites with available patients and resources. Consequently, studies are requiring more sites than would be suggested by historical enrollment data, and/or extended recruitment windows.
Another factor heavily impacting on the most efficient recruitment strategy for RA biosimilar trials is whether to include only biologic naïve vs biologic experienced RA patients. This choice will drive the mix of geographic locations for planned sites, since targeting biologic-naïve patients will require a bias towards countries outside of the most established markets (e.g. US.. and Western Europe), where a significant portion of patients with moderate-to-severe RA have already been treated with biological agents.6.此外,对仿生物药品的热情,一个extent experience/comfort in using them, is much higher in emerging markets where access to the originator biologics has typically been constrained due to cost. In contrast, within North America and Western Europe, there is little incentive for patients to participate in biosimilar clinical studies, since significant levels of reimbursement for biologics already exists through government funding and/or private healthcare insurance.7.
正如以前博客所讨论的那样7., the existing pool of RA Investigators is saturated with clinical studies particularly focusing on innovative new treatments. Added to this, a proportion of these investigators will simply not be interested in participating in clinical studies of biosimilars, because their mechanism of action, efficacy and safety profiles are (by definition) well established.
招聘解决方案
It is obvious that the successful delivery of a biosimilar RA study requires a different approach. Covance is dedicated to assisting our clients in the development of biosimilars and offers a number of recruitment solutions including:
- 全球范围，使国家在新兴市场的目标，如果需要，可以获得对生物学的患者仍然大于发达市场，以及对生物仿制性的更大热情。
- A recent global outreach to RA investigators has established a database of >1000 investigators that have confirmed their interest in participating in RA biosimilar studies (see table 1). This database will allow Covance and our clients to immediately target a receptive group of physicians for future RA biosimilar studies, thus saving considerable time, effort and expense during study-specific site identification activities.
Table 1: Regional Distribution of Sites Interested in RA Biosimilar Studies
| Region | 对生物仿制性研究感兴亚博全站官网趣的研究人数 |
| 北美 | 234. |
| 拉丁美洲 | 17.8. |
| Western Europe | 152. |
| Eastern Europe | 358. |
| Asia Pacific | 117. |
| MENA | 6. |
| South Africa | 17. |
| TOTAL | 1062 |
- 与具有专业知识的专家招聘供应商建立了关系，以提高风湿病学家，患者和患者倡导群体的临床试验的概况。
- Perhaps an under-utilized resource in historical RA studies, possibly due to disease prevalence, the current RA trial landscape is now demanding their involvement.
- 更大的医生目前particip教育ating in, or interested in doing clinical research. In particular, the concept of biosimilars and the rigorous type of data required to demonstrate that biosimilars are comparably efficacious and safe in order for them to be licensed for use in RA or other indications.
- 在美国，我们的母公司（Labcorp）专有数据库包含> 324,000名未识别的RA患者;因此，Covance能够确定与治疗非活跃调查人员的医师的簇相对的指示特异性患者密度/热点。亚博全站官网将这种强大的数据与上述医生教育倡议联系在一起提供了识别新调查人员以及邻近的推荐网站。亚博全站官网此外，利用Labcorp的实验室设施的患者正在提供“选择”的机会，即“选择”，即直接联系参加临床试验。已经在这项倡议的婴儿期内，> 1300名患者选择了。
与创新商产品相比，生物仿制率为15％至35％的价格折扣的早期估计值得提供，但有很多折扣的实例就会得到更高的折扣。8.无论折扣的程度如何，就明显，生物仿制性可以显着提高患者对RA高效治疗的能力。遵守适当的强大监管途径和雇用正确的战略招聘举措，将确保尽可能快地制定生物仿制性候选人，从而高得多的RA患者获得了许多生物治疗所提供的福利。
References
- rompas s，goss t，amanuel s，et.al.al.证明生物仿制物的价值：概念框架。担任健康药物益处。2015年5月;8（3）：129-139。
- US Food and Drug Administration. Drugs: information for healthcare professionals (biosimilars). Updated March 6, 2015. http://bit.ly/2gWwWM3
- Trends – Hot Topic; Datamonitor Healthcare; DMKC0166679; Published 18 November 2016
- Citeline Trialtrove
- 新兴市场的生物仿制性;Datamonitor Healthcare;DMKC0172273
- Lai Z, La Noce A. Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example. RMD Open 2016; 2: e000154. doi:10.1136/rmdopen-2015-000154
- Regional Availability of and Reimbursement Models for Biologic Therapies to Treat RA Patients with Moderate to Severe Disease (Covance.com)
- Yu B. Am J Manag Care. 2016;22(5):378
