Reference
- Research and Markets. Biologics outsourcing global market. 2018 https://www.researchandmarkets.com/research/2d8jbq/global_biologics?w=12 accessed on 2020 Aug 15
- Report Linker. Biosimilars Market by Product, Manufacturing & Indication, Region – global Forecast to 2025. 2020 https://www.reportlinker.com/p04604343/Biosimilars-Market-by-Product-Manufacturing-Application-Global-Forecast-to.html?utm_source=GNW accessed on 2020 Aug 15
- Rathore AS, Bhargava A. Biosimilars in Developed Economies: overview, Status and Regulatory Considerations. Regulat Toxicol Pharmacol. 2020;110;104525 (1-10).
- European Medicines Agency. Guideline on similar biological medicinal products. 2014 [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf
- World Health Organization. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). 2009. [cited 202O Aug 15]. Available from: https://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
- US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. 2015. [cited 202O Aug 15]. Available from: https://www.fda.gov/media/82647/download
- European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance : quality issues Rev 1 2014. [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-0.pdf
- US Food and Drug Administration. Development of Therapeutic Protein Biosimilars: comparative Analytical Assessment and Other Quality-Related Considerations. 2019. [cited 202O Aug 15]. Available from: https://www.fda.gov/media/125484/download
- European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2014. [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf
- US Food and Drug Administration. Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. 2016. [cited 202O Aug 15]. Available from: https://www.fda.gov/media/88622/download
- US Food and Drug Administration. Considerations in Demonstrating Interchangeability With a Reference Product-Guidance for Industry. 2019. [cited 202O Aug 15]. Available from: https://www.fda.gov/media/124907/download
- US Food and Drug Administration. Labeling for Biosimilar Products. 2018. [cited 202O Aug 15]. Available from: https://www.fda.gov/media/96894/download
- US Food and Drug Administration. Reference Product Exclusivity for Biological Product Filed Under Section 351(a) of the PHS Act. 2014. [cited 202O Aug 15]. Available from: https://www.fda.gov/media/89049/download
- Rathore AS. Follow-on protein products: scientific issues, developments and challenges. Trends Biotechnol. 2009;27(12):698–705.
- Guttman A, Rathore AS, Krull IS. Bioanalytical tools for the characterization of biologics and biosimilars. LCGC N Am. 2012;30(5):415–421.
- European Medicines Agency. Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor. 2006. [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/annex-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins_en.pdf
- European Medicines Agency. Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins. 2016. [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-clinical-development-similar-biological-medicinal-products-containing-low_en.pdf
- European Medicines Agency. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. 2015. [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-clinical-development-similar-biological-medicinal-products-containing_en-0.pdf
- European Medicines Agency. Guideline on similar biological medicinal products containing interferon beta. 2013. [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-interferon-beta_en.pdf
- European Medicines Agency. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH) 2013. [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-clinical-development-similar-biological-medicinal-products-containing_en.pdf
- European Medicines Agency. Guideline on similar medicinal products containing somatropin. 2018.[cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/annex-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins_en-1.pdf
- European Medicines Agency. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins. 2018. [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-clinical-develop ment-similar-biological-medicinal-products-containing_en-1.pdf
- European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies- non clinical and clinical issues. 2012. [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf
- Krendyukov A, Schiestl M. Extrapolation concept at work with biosimilar: a decade of experience in oncology. ESMO Open. 2018;3:e000319.
- European Medicines Agency. Withdrawal Assessment Report for Insulin Human Long Marvel. 2008. [cited 202O Aug 15]. Available from: https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-insulin-human-long-marvel_en.pdf
- European Medicines Agency. Withdrawal Assessment Report For Insulin Human Rapid Marvel. 2008. [cited 202O Aug 20]. Available from: https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-insulin-human-rapid-marvel_en.pdf
- US Food and Drug Administration and Center for Drug Evaluation and Research Application Number: 761045Orig1s000 Clinical Review(s) 2019. [cited 202O Aug 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761045Orig1s000MedR.pdf
- US Food and Drug Administration and Center for Drug Evaluation and Research Approval Package for: application Number:761045Orig1s000. 2019. [cited 202O Aug 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761045Orig1s000Approv.pdf
- Rathore AS, Chhabra H, Bhargava A. Approval of Biosimilars: A review of unsuccessful regulatory filings. Expert Opin Biol Ther. 2020. DOI:10.1080/14712598.2020.1793954.
- European Medicines Agency. Refusal assessment report for Alpheon. 2006. [cited 202O Aug 20]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/alpheon-epar-refusal-public-assessment-report_en.pdf
- European Medicines Agency. Withdrawal Assessment Report Efgratin. 2016. [cited 202O Aug 20]. Available from: https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-efgratin_en.pdf
- European Medicines Agency. Withdrawal Assessment Report Isomarv medium. 2013 [cited 202O Aug 20]. Available from: https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-isomarv-medium_en.pdf
- European Medicines Agency. Withdrawal Assessment Report Zioxtenzo. 2016. [cited 202O Aug 20]. Available from: https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-zioxtenzo_en.pdf
- US Food and Drug Administration and Center for Drug Evaluation and Research. Application Number 761071 Orig1s000 Clinical Pharmacology and Biopharmaceutics review. 2017. [cited 202O Aug 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761071Orig1s000ClinPharmR.pdf
- US Food and Drug Administration. Questions and Answers on Biosimilar Development and the BPCI Act. 2018. [cited 202O Aug 15]. Available from: https://www.fda.gov/media/119258/download