Pharmaceutical Technology - May 2019

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50 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 P h a r mTe c h . c o m lack of progress (21). In Europe, there may be 70 biosimilars by 2020, and then a second wave of patent expirations will widen the available armamentarium. With the biosimilars marketed in Europe and the US, the record of safety and efficacy has been excellent thus far. It can be surmised that so far, the regulatory process has appeared to be robust enough to prevent clinical issues, even across use of biosimilars by millions of patients. This bodes well for the future of biosimilars. References 1. FDA, Biosimilar and Interchangeable Products, FDA.gov, Up- dated October 2017, www.fda.gov/Drugs/DevelopmentApprov- a lProcess/HowDr ugsa reDevelopeda nd Approved /Approva- lApplications/TherapeuticBiologicApplications/Biosimilars/ ucm580419.htm#biosimilar, accessed October 16, 2018. 2. Jacoby Rob, Biosimilars: Tapping the Potential of Emerging Markets, Deloitte Blog, Aug. 24, 2015, http://blogs.deloitte.com/ centerforhealthsolutions/biosimilars-tapping-the-potential-of- emerging-markets/, Accessed June 21, 2018. 3. E M A , E u r o p e a n P u b l i c A s s e s s m e nt R e p or t s , E M A . E u - ropa .eu., w w w.ema .eu ropa .eu /med ici nes/f ield _ ema _web_ c at e gor ie s%2 53A n a me _ f ie ld / Hu m a n /e m a _ g roup_ t y p e s / ema_medicine/field_ema_med_status/authorised-36/ema_medi- cine_types/field_ema_med_biosimilar/search_api_aggregation_ ema_medicine_types/field_ema_med_biosimilar, Accessed 13 February 2019. 4. O. Kwon, et al., Biologicals 48 pp .101-108 (2017). 5. FDA, FDA-Approved Biosimilar Products, FDA.gov, www.fda. gov/drugs/developmentapprovalprocess/howdrugsaredeveloped- andapproved/approvalapplications/therapeuticbiologicapplica- tions/biosimilars/ucm580432.htm, accessed July 5, 2018. 6. AG Vulto and OA Jaquez, Rheumatology, 56 (4) pp. iv14-19 (2017). doi:10.1093/rheumatology/kex278 7. SK Singh, D. Kumar, and A.S. Rathore, AAPS, 19 (6) pp.1826-1841 (2017), doi:10.1208/s12248-017-0139-8. 8. GaBI, Comparison of EPARs for G-CSF Biosimilars Approved in Europe, GaBI Journal. Generics And Biosimilar Initiative, Feb. 22, 2013, http://gabi-journal.net/news/comparison-of-epars-for- g-csf-biosimilars-approved-in-europe, accessed June 21, 2018. 9. M. McCamish and G. Woollett, Clinical Pharmacology & Thera- peutics, 93 (4) pp. 315–317 (2013). doi:10.1038/clpt.2013.17 10. B. Sharma, Biotechnol. Advances, 25 (3) pp. 325-331 (2007). 11. AJ Chirino and A. Mire-Sluis, Nat Biotechnol, 22 (11) pp.1383- 1391 (2004), doi:10.1038/nbt1030 12. N. Nupur et al., MAbs, 10 (1) pp. 143-158 (2018), doi:10.1080/194 20862.2017.1402996 13. N. Nupur et a l., J Chromatog r B, 1032 pp. 165-171 (2016), doi:10.1016/j.jchromb.2016.05.027 14 . A. Covic and MK Kuhlmann, Int Urol Nephrol, 39 (1) (2007), pp.261-266. doi:10.1007/s11255-006-9167-5 15. C.L. Bennett, et al. N Engl J Med. 351 (14) pp. 1403-1408 (2004), doi:10.1056/NEJMoa040528 16. EMA, Pharmacovigilance–EudraVigilance, www.ema.europa. eu, www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/ general/general_content_000679.jsp., accessed June 21, 2018. 17. FDA, MedWatch: The FDA Safety Information and Adverse Event Reporting Program, www.fda.gov/Safety/MedWatch/default.htm, accessed June 21, 2018. 18. FDA, Nonproprietary Naming of Biological Products, Guidance for Industry (CDER, 2017). 19. D. Tomaszewski, J Manag Care Spec Pharm, 22 (8) pp. 919-926 (2016), www.jmcp.org/doi/pdf/10.18553/jmcp.2016.22.8.919, Ac- cessed June 21, 2018. 20. Eu ropea n Com mission, Interna l Ma rket, Indust r y, Ent re- preneu rsh ip a nd SM E s , Fou r t h St a keholder C on ferenc e on Biosimilars, ht tp://ec.europa.eu/research/hea lt h/index. cfm?pg=policy&policyname=global_forum, accessed April 29, 2019. 21. J. Wechsler, "FDA's Gottlieb Hits Innovators, Insurers for Block- ing Biosimilar Uptake," PharmExec.com, March 8, 2018, www. pharmexec.com/fda-s-gottlieb-hits-innovators-insurers-block- ing-biosimilar-uptake. 22. E. Moorkens et al., PLoS ONE, 12 pp.1-17 (2017), https://doi. org/10.1371/journal.pone.0190147 23. V. Razanskaite et al., Journal of Crohn's and Colitis, 11 pp.690– 696 (2017), https://doi.org/10.1093/ecco-jcc/jjw216 24. L.E., Kristensen et al., Biodrugs, 32 pp.397-404 (2018), https:// link.springer.com/article/10.1007%2Fs40259-018-0306-1 25. EMA, What I need to know about Biosimilar Medicines–In- formation for patients, http://ec.europa.eu/DocsRoom/docu- ments/26643, accessed July 5, 2018. PT Biosimilars AMRI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 CATALENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 CONTEC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 EMERGENT BIOSOLUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 LONZA BIOLOGICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 PATHEON PHARMACEUTICAL SERVICES INC . . . . . . . . . . . . . . . . . . . . 25 PERFEX CORP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 SARTORIUS STEDIM NA INC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 VELTEK ASSOCIATES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Ad Index COMPANY PAGE

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