相关临床试验
23
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1994
已完成
21
91.3%
招募中
1
4.3%
Unknown
1
4.3%
暂无批准数据
- The European Commission granted centralised marketing authorisation for Zandoriah (teriparatide), a biosimilar to Forsteo, for treating osteoporosis in adults across all 27 EU member states plus Iceland, Liechtenstein, and Norway. - This marks the first-ever European marketing authorisation for an Iranian pharmaceutical company, representing a historic milestone for Iran's pharmaceutical industry. - Zandoriah demonstrated comparable quality, safety, and efficacy to the reference product through comparability studies conducted in accordance with EMA biosimilar requirements. - The approval addresses a significant treatment gap, with an estimated 71% of eligible women remaining untreated for osteoporosis, a condition that caused 4.3 million fragility fractures and over €56 billion in healthcare costs across Europe in 2019.
- A phase III crossover study in Iran demonstrated that biosimilar laronidase (CinnaGen) maintained stable urinary GAG levels comparable to reference Aldurazyme in 12 MPS I patients over 24 weeks. - Both treatments showed similar enzyme activity profiles and safety outcomes, with no clinically meaningful differences in 6-minute walking test or forced vital capacity results. - The biosimilar maintained therapeutic efficacy without significant clinical deterioration, supporting its potential as a more affordable alternative to the reference enzyme replacement therapy. - A separate Chinese phase IV study of 12 MPS I patients confirmed laronidase's established safety profile, with 64.61% reduction in urinary GAG levels after 26 weeks of treatment.
