NCCN biosimilars white paper: Regulatory, scientific, and patient safety perspectives Journal Article
| Authors: | Zelenetz, A. D.; Ahmed, I.; Braud, E. L.; Cross, J. D.; Davenport-Ennis, N.; Dickinson, B. D.; Goldberg, S. E.; Gottlieb, S.; Johnson, P. E.; Lyman, G. H.; Markus, R.; Matulonis, U. A.; Reinke, D.; Li, E. C.; DeMartino, J.; Larsen, J. K.; Hoffman, J. M. |
| Article Title: | NCCN biosimilars white paper: Regulatory, scientific, and patient safety perspectives |
| Abstract: | Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The potential for biosimilars to reduce the cost of biologics, which are often high-cost components of oncology care, was the impetus behind the Biologics Price Competition and Innovation Act of 2009, a part of the 2010 Affordable Care Act. In March 2011, NCCN assembled a work group consisting of thought leaders from NCCN Member Institutions and other organizations, to provide guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars in health care practice. The work group identified challenges surrounding biosimilars, including health care provider knowledge, substitution practices, pharmacovigilance, naming and product tracking, coverage and reimbursement, use in off-label settings, and data requirements for approval. © JNCCN-Journal of the National Comprehensive Cancer Network. |
| Keywords: | cancer chemotherapy; cancer survival; protein expression; neutropenia; review; bevacizumab; doxorubicin; interferon; drug safety; antineoplastic agents; drug approval; united states; gemcitabine; paclitaxel; cancer patient; rituximab; topotecan; neoplasms; bortezomib; patient education; bendamustine; practice guideline; food and drug administration; cetuximab; cancer therapy; docetaxel; panitumumab; temsirolimus; europe; health care policy; leuprorelin; cost control; health care cost; law; prescription; health policy; standardization; molecular cloning; b cell lymphoma; protein purification; protein synthesis; patient safety; health care personnel; medical practice; consensus development; world health organization; 5 aza 2' deoxycytidine; large cell lymphoma; biological therapy; trastuzumab; recombinant granulocyte colony stimulating factor; oxaliplatin; pemetrexed; recombinant erythropoietin; azacitidine; fulvestrant; ixabepilone; government regulation; drug indication; european union; novel erythropoiesis stimulating protein; off label drug use; biosimilars; follow-on biologics; biosimilar pharmaceuticals; drugs, generic |
| Journal Title: | Journal of the National Comprehensive Cancer Network |
| Volume: | 9 |
| Issue: | SUPPL. 4 |
| ISSN: | 1540-1405 |
| Publisher: | Harborside Press |
| Date Published: | 2011-09-01 |
| Start Page: | S1 |
| End Page: | S22 |
| Language: | English |
| PROVIDER: | scopus |
| PUBMED: | 21976013 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 9 December 2011" - "Source: Scopus" |
