Biosimilars Connect
  • Saved
Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

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.

  • Saved
Adalimumab

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...

  • Saved
Uptake and Competition Among Biosimilar Biological Products in the US Medicare Fee-for-Service Poplation - Journal of General Internal Medicine

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.

  • Saved
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

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.

  • Saved
Usefulness of Prophylactic Administration of Pegfilgrastim for Esophageal Cancer Chemotherapy: A Single-center Retrospective Study

Usefulness of Prophylactic Administration of Pegfilgrastim for Esophageal Cancer Chemotherapy: A Single-center Retrospective Study

Source : https://ar.iiarjournals.org/content/42/5/2783.long

Background/Aim: To evaluate the impact of prophylactic administration of pegfilgrastim in esophageal cancer (EC) patients treated with chemotherapy consisted of docetaxel, cisplatin, and fluorouracil (DCF). Patients and Methods: Among 102...


Conclusion: Prophylactic pegfilgrastim in DCF may relieve adverse events and improve the oncologic outcome of EC patients.