geoscience.net logo
+ Resolve Article
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter

+ Translate
+ Subscribe to Site Feed
GeoScience Most Shared ContentMost Shared Content

Biosimilars: a regulatory perspective from America


, : Biosimilars: a regulatory perspective from America. Arthritis Research & Therapy 13(3): 112-112

Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source products and recombinant proteins have been approved as generic drugs under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. However, because the complexity of large biopharmaceuticals makes it difficult to demonstrate that a biosimilar is structurally identical to an already approved biopharmaceutical, this Act does not apply to biosimilars of large biopharmaceuticals. Section 7002 of the Patient Protection and Affordable Care Act of 2010, which is referred to as the Biologics Price Competition and Innovation Act of 2009, amends Section 351 of the Public Health Service Act to create an abbreviated pathway that permits a biosimilar to be evaluated by comparing it with only a single reference biological product. This paper reviews the processes for approval of biosimilars in the US and the European Union and highlights recent changes in federal regulations governing the approval of biosimilars in the US.

US$19.90

PMID: 21586106

DOI: 10.1186/ar3310


Other references

Prata, Aízio.; Ruiz-Guevara, R.; Antunes, C.Mauricio.de.Figueiredo.; Marinho, C.Coimbra.; Queiroz, L.Campos.; Voieta, I.; Lambertucci, Jé.Roberto., 2010: Comparison between clinical and ultrasonographic findings in cases of periportal fibrosis in an endemic area for schistosomiasis mansoni in Brazil. Abdominal palpation and ultrasound findings among patients from an endemic area for schistosomiasis in Brazil who had been followed up for 27 years were compared. In 2004, 411 patients from Brejo do Espírito Santo, in the State of Bahia, were sel...

Lauber, A.; Deetjen, W.; Jehle, J.; Pölitz, B.; Schmiel, F.K.; Spiller, P., 1984: Digital subtraction angiocardiography: accuracy of measuring left ventricular wall thickness and wall volume during intravenous contrast media injection. A comparison of left ventricular wall thickness and wall volume determined by intravenous digital subtraction angiocardiography and by conventional left ventricular angiocardiography was performed by linear regression analysis: wall thickness: WDD...

Mincher, D.J.; Shaw, G., 1984: Anthracyclinones 2. the use of 1 2 5 6 di o isopropylidene alpha d glucofuranose as a chiral template precursor in an anthracyclinone synthesis. Reaction of 3-O-benzyl-1,2-O-isopropylidene-.alpha.-D-xylo-pentodialdofuranose-(1,4) with leuco-quinizarin in alkaline solution at 0.degree. C, followed by aerial oxidation, gave a good yield of (5S)-3-O-benzyl-1,2-O-isopropylidene-5-(quinizarin-2...

Katayama, T.; Yano, K.; Nakashima, H.; Takagi, C.; Honda, Y.; Suzuki, S.; Iwasaki, Y., 2005: Clinical significance of acute-phase endothelin-1 in acute myocardial infarction patients treated with direct coronary angioplasty. Background The aim of the present study was to investigate the relationship between plasma concentrations of endothelin (ET)-1 and clinical outcome (including mortality) and left ventricular (LV) systolic function in acute myocardial infarction (A...

Eriksson H.; Taylor W.; Sjovall J., 1977: Sex differences in sulfation and excretion of 5 alpha cholanoic acids in rats. Paumgartner, G And A Stiehl (Ed ) Falk Symposium, No 24 Bile Acid Metabolism in Health And Disease Proceedings Of The Iv Bile Acid Meeting, Basel, Switzerland, Oct 11-12, 1976 Xvii+297p Illus University Park Press: Baltimore, Md , Usa; Mtp Press: Lancaster, Engl Isbn 0-8391-1143-6 75-81

Kropp, RK., 1987: Descriptions of some endolithic habitats for snapping shrimp (Alpheidae) in Micronesia. Bulletin of Marine Science, 412: 204-213

Weltman A.; Seip R.; Rutt R.; Tran Z.V., 1988: Estimation of body composition changes with weight loss. Medicine & Science in Sports & Exercise 20(2 SUPPL): S41

Hoffmann, D.E.; Fortenberry, J.Dennis.; Ravel, J., 2014: Are changes to the common rule necessary to address evolving areas of research? A case study focusing on the human microbiome project. This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a "reference catalogue" of the micro-organisms present in the human body and determine how changes in those micro-organisms...

Dunhill, T.P., 1925: An Address ON DUODENAL AND GASTRIC ULCERATION: SOME PERSONAL EXPERIENCES. British Medical Journal 1(3363): 1069-1073

Walden, J., 2005: Students should get a taste of life on the wards before they train. NlmCategory="UNASSIGNED">Many people do not realise what nursing is really like and may decide, for a number of reasons, it is not for them the minute they go on to a ward (news February 9). However, there are other issues to be addre...