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Biosimilar medical products – licensing, pharmacovigilance and interchangeability

REFERENCES 1. Dolinar RO, Reilly MS. The future of biological therapy: a pathway forward for biosimilars. GaBI Journal. 2013; 2(1): 36–40. 2. Berkowitz SA, Engen JR, Mazzeo JR, Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov. 2012; 11 (7): 527–540. 3. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al. Biosimilars: what clinicians should know. Blood 2012; 120 (26): 5111–5117. 4. Fineberg SE, Kawabata TT, Finco-Kent D, Fountaine RJ, Finch GL, Krasner

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Biosimilar medicines and patient registries – expectations, limitations, and opportunities

, Nejdkova A, Pajerchin D, Pec J jr., Pec M, Rasochova E, Stracenska J, Vrtikova E, Zaujec L. Liecba psoriazy acitretinom. 1. vydanie. Bratislava: Univerzita Komenského; 2007. 3. European Medicines Agency, “ http://www.ema.europa.eu ,” [Online]. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf . [Accessed 28 november 2017]. 4. U.S. Food and drug administration, “ www.fda.gov ,” [Online]. Available: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars

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Current regulatory and market environment for biosimilars in Serbia

References 1. Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC. Safety-related regulatory actions for biologicals approved in the United States and the European Union. J Am Med Assoc 2008; 300: 1887-96. 2. EvaluatePharma® World Preview to 2012, 6 June 2008. 3. Kresse GB. Biosimilars - science, status and strategic perspective. Eur J Pharm Biopharm 2009; 72: 479-86. 4. Grabowski HG, Ridley DB, Schulman KA. Entry and competition in generic biologics

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Stosowanie leków biopodobnych w hematoonkologii – stanowisko Polskiego Towarzystwa Hematologów i Transfuzjologów

). Definicja Leki biopodobne a generyki Leki biopodobne ( biosimilars , „ follow-on pharmaceuticals ”, subsequent entry biologics , biocomparables ) są produktami medycznymi zawierającymi substancję czynną podobną, choć nie identyczną z referencyjną substancją oryginalną, wytwarzaną w komórkach żywych organizmów. Dopuszczalne są niewielkie różnice w budowie cząsteczki, które zgodnie z założeniem nie powinny powodować klinicznie istotnych różnic pomiędzy referencyjnym lekiem biologicznym a lekiem biopodobnym. Lekami biopodobnymi mogą być hormony, małe cząsteczki

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Biological therapies in psoriasis - revisited

Medicines: Biosimilars. [Accessed 22.06.2017]. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_001832.jsp&mid=WC0b01ac0580bb8fda 68. MAZUR M, OLEK-HRAB K, KARCZEWSKI J, et al . Biosimilars in dermatology . Advances in Dermatology and Allergology/Postẹpy Dermatologii i Alergologii. 2015; 32 (5):384. 69. RADTKE MA, AUGUSTIN M. Biosimilars in psoriasis: what can we expect? JDDG: Journal der Deutschen Dermatologischen Gesellschaft. 2014; 12 (4):306-12. 70. NAST A, ROSUMECK S, SEIDENSCHNUR K

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EULAR recommendations for the management of rheumatoid arthritis: what is new in 2017 and its applicability in our local setting

remission, especially if treatment is combined with a csDMARD No recommendation All approved bsDMARDs have similar efficacy and safety as the respective boDMARDs, and should be preferred if the cost is lower. No recommendation MTX = methotrexate; csDMARD = conventional synthetic disease modifying anti-rheumatic drugs; bDMARD = biologic DMARD; tsDMARD = targeted synthetic DMARD; bsDMARD = biosimilar DMARD; boDMARD = biological originator DMARD; T2T = treat-to-target; GC = glucocorticoid 2 Use of csDMARDs at phase I of the therapeutic

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The Hong Kong Society of Rheumatology Biologics Registry: Updated Report (Nov 2018)

(0.4) 8 (0.4) Ustekinumab 16 (0.3) 6 (0.3) Pamidronate 11 (0.2) 0 (0.0) Remsima 1 (0.02) 1 (0.05) (biosimilar of Infliximab) Total 4848 (100) 2106 (100) Figure 1 Use of b/tsDMARDs in rheumatoid arthritis (up to Nov 2018) Figure 2 Use of bDMARDs in spondyloarthritis (up to Nov 2018) Figure 3 Use of bDMARDs in Psoriatic arthritis (up to Nov 2018) The number of patients who withdrew from treatment at different time points is shown in Table 3 . The three most commonly reported reasons

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The Trans-Pacific Partnership

, supra note 185, at 22 n. 7. For a certain period of time, data protection precludes the regulator from using data submitted by the developer of an innovative pharmaceutical in order to receive marketing approval, such as clinical trial results, to grant approval to a generic form of the same medicine. See e.g ., TPP, supra note 24, art. 18.50. Once the data protection period expires, the regulator may use the information provided by the innovator to allow for faster approval of generic or biosimilar versions, avoiding the unnecessary duplication of some human or

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