Conhecimento altamente especializado
A Amgen aplica sua ampla experiência com medicamentos
biológicos aos seus biossimilares
A próxima geração na produção de biossimilares
O desenvolvimento de medicamentos biológicos é um processo altamente especializado com múltiplas etapas.1 A Amgen possui Profunda experiência em todas as fases, do desenvolvimento à produção, para ajudar a garantir o fornecimento contínuo de medicamentos.
O desenvolvimento de biossimilares é igualmente complexo,1 e nosso conhecimento de medicamentos biológicos, acumulado ao longo de mais de quatro décadas, significa que estamos preparados para a tarefa. Usamos os mesmos processos, padrões científicos e sistemas de qualidade na produção dos nossos medicamentos biológicos e dos nossos biossimilares.
References: 1. Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014;3:889-899. 2. Aspirin prescribing information, Bayer. 3. Insulin product information, Sigma-Aldrich, 2014. 4. Online Mendelian Inheritance in Man. Growth Hormone 1; GH1. www.omim.org/entry/139250. Accessed January 10, 2019. 5. Charles D, Chapman MA. Institute for Patient Access. What is indication extrapolation and should it be allowed with biological medications? 1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2013/08/TPP_IndicationExtrapolation0914Final.pdf. Accessed January 10, 2019. 6. European Medicines Agency. Q&A on biosimiliar medicines. www.medicinesforeurope.com/wp-content/uploads/2016/03/WC500020062.pdf. Accessed January 23, 2019. 7. Berkowitz SA, Engen JR, Mazzeo JR, Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov. 2012;11:527-540. 8. Lipman NS, Jackson LR, Trudel LJ, Weis-Garcia F. Monoclonal versus polyclonal antibodies: distinguishing characteristics, applications, and information resources. ILAR J. 2005;46:258-268. 9. McKinsey & Company. From science to operations: Questions, choices and strategies for success in biopharma. www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/from-science-to-operations-questions-choices-and-strategies-for-success-in-biopharma. Published March 2014. Accessed January 10, 2019. 10. US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity of a Therapeutic Protein to a Reference Product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Published April 2015. Accessed January 10, 2019.