Efficacy, Safety, and Immunogenicity of Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 Compared with Originator Insulin Aspart Mix 70/30 in Adults with Diabetes (GEMELLI M): A Subgroup Analysis by Prior Type of Premix Insulin - Diabetes Therapy
Source : https://link.springer.com/article/10.1007/s13300-022-01279-z
Introduction We compared the efficacy, safety, and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (70% intermediate SAR341402 protamine and 30% rapid SAR341402 solution) (SARAsp-Mix) with its originator NovoMix...
Conclusions: Efficacy, safety, and immunogenicity profiles of SARAsp-Mix are similar to NN-Mix over 26 weeks in adults with diabetes irrespective of prior type of premix insulin.
Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis
Source : https://www.frontiersin.org/articles/10.3389/fimmu.2021.638444/full
Adalimumab, as a TNF inhibitor biologic for the treatment of rheumatoid arthritis, is one of the top-selling drugs worldwide. As its various patents have gradually expired, experiments on its biosimilars...
Conclusion: Overall, these biosimilars showed similar efficacy, safety, and immunogenicity to adalimumab. All biosimilar switching trials indicated that switching from adalimumab to a biosimilar does not have a significant impact on efficacy, safety, and immunogenicity.
Adalimumab
Source : https://www.ncbi.nlm.nih.gov/books/NBK501392/
Limited information indicates that maternal adalimumab injections produce low levels in breastmilk and do not adversely affect the nursing infant. Because adalimumab is a large protein molecule with a molecular...
Summary: Limited information indicates that maternal adalimumab injections produce low levels in breastmilk and do not adversely affect the nursing infant. Because adalimumab is a large protein molecule with a molecular weight of about 148,000 Da, it is likely to be partially destroyed in the infant's gastrointestinal tract and absorption by...
Uptake and Competition Among Biosimilar Biological Products in the US Medicare Fee-for-Service Poplation - Journal of General Internal Medicine
Source : https://link.springer.com/article/10.1007/s11606-022-07670-7
The Biologics Price Competition and Innovation Act of 2009 created an abbreviated US approval pathway for biosimilar and interchangeable biological products. Biological products are usually large, complex molecules, in contrast...
Relevance: Our study evaluated factors that may influence biosimilar uptake, including market order entry, clinical setting, and initial publicized pricing discounts.
HLX11, a Proposed Pertuzumab Biosimilar: Pharmacokinetics, Immunogenicity, and Safety Profiles Compared to Three Reference Biologic Products (US-, EU-, and CN-Approved Pertuzumab) Administered to Healthy Male Subjects - PubMed
Source : https://pubmed.ncbi.nlm.nih.gov/35594017/
1 Department of Clinical Pharmacology, The Second Hospital of Anhui Medical University, Hefei, Anhui, People's Republic of China. 2 Anhui Provincial Institute of Translational Medicine, Hefei, Anhui, People's Republic of...
Conclusion: The PK, safety, and immunogenicity of HLX11 were highly similar to those of reference pertuzumab (US-, EU-, CN-approved products). The established bioequivalence supports further clinical trials of HLX11 in cancer treatment.