Department of Neurosurgery Hunterian Laboratories, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Curr Med Res Opin. 2021 Jan;37(1):83-88. doi: 10.1080/03007995.2020.1840971. Epub 2020 Nov 24.
Regulations for new drug approvals require stringent safety testing and efficacy trial programs. The approval process for generic drugs, however, is significantly streamlined. Bioavailability data can substitute for new rounds of efficacy trials, thereby both decreasing time to approval and reducing the costs required for new studies. This regulatory choice has not been available when generic drugs are offered in a controlled release format such as a subcutaneous depot, transdermal patch or implant. The purpose of this review is to suggest that the approval of generic drugs in inert controlled release envelopes should be eligible for similar regulatory relief. Proof for this concept is provided by the example of the numerous controlled release buprenorphine products. Buprenorphine is a generic opioid used since the 1980s in tablet form to treat pain and to treat opioid addiction. Long-acting, inert delivery vehicles for the drug have become available for the same indications. Safety and bioavailability profiles of the long-acting products are the same or improved over the parent product. A review of the long-acting drugs provides compelling evidence to recommend that generic drug-controlled release products may be eligible for alternative regulatory programs.
新药批准的规定要求进行严格的安全性测试和疗效试验方案。然而，仿制药的审批程序大大简化。生物利用度数据可以替代新的疗效试验，从而缩短批准时间并降低新研究所需的成本。当以皮下储库、透皮贴剂或植入物等控制释放形式提供仿制药时，这种监管选择是不可用的。本文的目的是建议，在惰性控制释放包中批准仿制药应符合类似的监管缓解。这一概念的证据来自众多控制释放丁丙诺啡产品的例子。丁丙诺啡是一种自 20 世纪 80 年代以来以片剂形式用于治疗疼痛和治疗阿片类药物成瘾的通用类阿片药物。该药物的长效、惰性输送载体已可用于相同的适应症。长效产品的安全性和生物利用度与母体产品相同或有所改善。对长效药物的审查提供了令人信服的证据，建议将仿制药控制释放产品有资格获得替代监管方案。
