-
1
-
-
77955597659
-
Addressing the health technology assessment of biosimilar pharmaceuticals
-
10.1185/03007995.2010.505137 20649394
-
Addressing the health technology assessment of biosimilar pharmaceuticals. Stewart A, Aubrey P, Belsey J, Curr Med Res Opin 2010 26 2119 2126 10.1185/03007995.2010.505137 20649394
-
(2010)
Curr Med Res Opin
, vol.26
, pp. 2119-2126
-
-
Stewart, A.1
Aubrey, P.2
Belsey, J.3
-
3
-
-
84871380050
-
Generics and Biosimilars Initiative
-
Available from
-
Generics and Biosimilars Initiative. GaBI Online, Current status of biosimilar development Available from: http://www.gabionline.net/Biosimilars/ General/Current-status-of-biosimilar-development
-
Current Status of Biosimilar Development
-
-
Online, G.1
-
4
-
-
84872387851
-
Quantitative evaluation of bioequivalence/biosimilarity
-
Available from
-
Quantitative evaluation of bioequivalence/biosimilarity. Chow SC, J Bioequiv Availab 2011 Available from: http://www.gabionline.net/Biosimilars/ Research/Quantitative-evaluation-of-bioequivalence
-
(2011)
J Bioequiv Availab
-
-
Chow, S.C.1
-
5
-
-
77951028492
-
Biosimilars: Controversies as illustrated by rhGH
-
10.1185/03007991003719642 20302553
-
Biosimilars: controversies as illustrated by rhGH. Declerck PJ, Darendeliler F, Gáth M, Kolouskova S, Micle I, Noordam C, et al. Curr Med Res Opin 2010 26 1219 29 10.1185/03007991003719642 20302553
-
(2010)
Curr Med Res Opin
, vol.26
, pp. 1219-1229
-
-
Declerck, P.J.1
Darendeliler, F.2
Gáth, M.3
Kolouskova, S.4
Micle, I.5
Noordam, C.6
-
6
-
-
42049123626
-
Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues
-
Available from
-
Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. European Medicines Agency, Guidance on similar medicinal products containing somatropin 2006 Available from: http://www.ema.europa.eu/pdfs/human/ biosimilar/9452805en.pdf
-
(2006)
Guidance on Similar Medicinal Products Containing Somatropin
-
-
Medicines Agency, E.1
-
7
-
-
80053573414
-
WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24-26 August, 2010
-
10.1016/j.biologicals.2011.08.009 21906959
-
WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24-26 August, 2010. Wadhwa M, Kang HN, Knezevic I, Thorpe R, Griffiths E, Biologicals 2011 39 349 357 10.1016/j.biologicals.2011.08.009 21906959
-
(2011)
Biologicals
, vol.39
, pp. 349-357
-
-
Wadhwa, M.1
Kang, H.N.2
Knezevic, I.3
Thorpe, R.4
Griffiths, E.5
-
9
-
-
74049092678
-
Clinical comparability and European biosimilar regulations
-
10.1038/nbt0110-28 20062035
-
Clinical comparability and European biosimilar regulations. Schellekens H, Moors E, Nat Biotechnol 2010 28 28 31 10.1038/nbt0110-28 20062035
-
(2010)
Nat Biotechnol
, vol.28
, pp. 28-31
-
-
Schellekens, H.1
Moors, E.2
-
10
-
-
79952744875
-
Worldwide experience with biosimilar development
-
10.4161/mabs.3.2.15005 21441787
-
Worldwide experience with biosimilar development. McCamish M, Woollert G, MAbs 2011 3 209 17 10.4161/mabs.3.2.15005 21441787
-
(2011)
MAbs
, vol.3
, pp. 209-217
-
-
McCamish, M.1
Woollert, G.2
-
11
-
-
19044374719
-
Biosimilar epoetins: How similar are they?
-
Biosimilar epoetins: how similar are they? Schellekens H, Eur J Hosp Pharm 2004 10 243 7
-
(2004)
Eur J Hosp Pharm
, vol.10
, pp. 243-247
-
-
Schellekens, H.1
-
12
-
-
70049109465
-
Binocrit: Assemssment of quality, safety and efficacy of biopharmaceuticals
-
Binocrit: assemssment of quality, safety and efficacy of biopharmaceuticals. Brockmeyer C, Seidl A, Eur J Hosp Pharm Prac 2009 15 34 40
-
(2009)
Eur J Hosp Pharm Prac
, vol.15
, pp. 34-40
-
-
Brockmeyer, C.1
Seidl, A.2
-
13
-
-
79952973241
-
Biosimilar medicines and cost-effectiveness
-
21935330
-
Biosimilar medicines and cost-effectiveness. Simoens S, Clinicoecon Outcomes Res 2011 3 29 36 21935330
-
(2011)
Clinicoecon Outcomes Res
, vol.3
, pp. 29-36
-
-
Simoens, S.1
-
14
-
-
84871364687
-
The EGAs thoughts on how to improve the legal and regulatory framework for generic and biosimilar medicines
-
Available from Generic Medicines Association E.
-
The EGAs thoughts on how to improve the legal and regulatory framework for generic and biosimilar medicines. European Generic Medicines Association, Vision 2015 2010 Available from: http://www.egagenerics.com/doc/EGA-Vision-2015. pdf
-
(2010)
Vision 2015
-
-
-
15
-
-
84871384692
-
Generics and biosimilars initiative
-
Available from: http://www.gabionline.net/Biosimilars/News/Sandoz- announces-biosimilar-rituximab
-
Generics and biosimilars initiative. GaBI Online, Sandoz announces biosimilar Available from: http://www.gabionline.net/Biosimilars/News/Sandoz- announces-biosimilar-rituximab
-
Sandoz Announces Biosimilar
-
-
Online, G.1
-
16
-
-
84871371575
-
Generics and biosimilars initiative
-
Available from: http://www.gabionline.net/Biosimilars/News/Biosimilars- boost-for-South-Korea
-
Generics and biosimilars initiative. GaBI Online, Biosimilars boost for South Korea Available from: http://www.gabionline.net/Biosimilars/News/ Biosimilars-boost-for-South-Korea
-
Biosimilars Boost for South Korea
-
-
Online, G.1
-
17
-
-
80053573760
-
Current regulatory and scientific considerations for approving biosimilars in Iran
-
10.1016/j.biologicals.2011.06.019 21873077
-
Current regulatory and scientific considerations for approving biosimilars in Iran. Hadavand N, Valadkhani M, Zarbakhsh A, Biologicals 2011 39 325 327 10.1016/j.biologicals.2011.06.019 21873077
-
(2011)
Biologicals
, vol.39
, pp. 325-327
-
-
Hadavand, N.1
Valadkhani, M.2
Zarbakhsh, A.3
-
19
-
-
69749106377
-
New national drug policy in Iran leading to expanded pharmaceutical market and extended access of public to medicines
-
New national drug policy in Iran leading to expanded pharmaceutical market and extended access of public to medicines. Dinarvand R, Iran J Publ Health 2009 38 S1 158 161
-
(2009)
Iran J Publ Health
, vol.38
, Issue.1
, pp. 158-161
-
-
Dinarvand, R.1
-
20
-
-
79960441546
-
Pharmaceutical market and health system in the Middle Eastern and Central Asian countries: Time for innovations and changes in policies and actions
-
Pharmaceutical market and health system in the Middle Eastern and Central Asian countries: Time for innovations and changes in policies and actions. Abdollahiasl A, Nikfar S, Abdollahi M, Arch Med Sci 2011 3 365 367
-
(2011)
Arch Med Sci
, vol.3
, pp. 365-367
-
-
Abdollahiasl, A.1
Nikfar, S.2
Abdollahi, M.3
|