Targeted development of biosimilar pharmaceutical products

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Biosimilar Guidelines – Overview Defines principles General guidelines Quality / Safety Efficacy Product class specific data requirements Overarching Guideline (CHMP/437/04). „Guideline on Similar Biological Medicinal Products.“ Biotechnology – derived proteins Quality Nonclinical Clinical Insulin Somatropin GCSF Epoetin IFN-a LMWH Nonclinical Clinical Nonclinical Clinical Nonclinical Clinical Nonclinical Clinical 10 | Thomas Stangler | EAPB SIG Regulatory Aspects for Biopharmaceuticals | October 4th, 2010 | Business use only Nonclinical Clinical Nonclinical Clinical mAbs under discussion
Quality: A full quality dossier supplemented by the demonstration of comparability. Full CTD M3 E.g. 3.2.S DS -Manufacture -description MP -control of materials .control of critical steps .process validation .manufacturing PD -Control DS -Reference standard -Container closure system -Stability Quality CTD M3+ Comparability vs. Reference -Not expected PQA are identical -Stepwise approach justifying differences in PQA -Differences PQA can impact requirements (non)clinical package -Reference product description 11 | Thomas Stangler | EAPB SIG Regulatory Aspects for Biopharmaceuticals | October 4th, 2010 | Business use only • EMEA/CHMP/BWP/49348/2005 Analytical Methods & Specifications -Use of state-of-the-art analytical methods -Physicochemical properties -Biological activity -Purity and impurities -Specifications defined and justified
Page 1 and 2: Targeted development of biosimilar
Page 3 and 4: Sandoz and Novartis have cutting ed
Page 5 and 6: …and are produced from geneticall
Page 7 and 8: Biosimilars development is a hybrid
Page 9: Biosimilars: The Regulatory Landsca
Page 13 and 14: Biosimilars are recognized around t
Page 15 and 16: Target-directed product development
Page 17 and 18: Starting a biosimilar development p
Page 19 and 20: ICH Q8, Q9 and Q10 19 | Thomas Stan
Page 21 and 22: Elements of QbD Pharmaceutical Deve
Page 23 and 24: Typical product quality attributes
Page 25 and 26: Factors Impacting Quality: Curse or
Page 27 and 28: Targeted cell line development: Dri
Page 29 and 30: Charge variant (%) 80 60 40 20 0 Ta
Page 31 and 32: QbD for Biosimilars and novel Bioph
Page 33 and 34: Final remarks! � Biosimilars are

Targeted development of biosimilar pharmaceutical products

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