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Biosimilar e-Learning Modules

Summary of key points, learning objectives, and selected references

With three UEMS-EACCME-accredited eLearning modules, learners can dive into the topic of biosimilars, increasing their understanding and knowledge for improved practical applications and outcomes.

Each eLearning module takes 45 minutes to complete and is worth 1 credit. The modules are accompanied by three freely downloadable slide decks that learners can share with peers (non-CME accredited). Up to five new peer-reviewed articles are added every month to complement the content.

Three expert guest editors act as independent expert reviewers, in line with UEMS guidelines, and curate the content of the three eLearning modules.

After completing the modules, learners will understand the definition of biosimilars, the regulatory pathways for biosimilars, and the clinical impact of biosimilars compared with originator biologic medicines.

Module 1: Putting the “bio” in “biotherapeutics”: differentiating between generics and biosimilars

Key content

  • Overview of small molecules and biologics, and the differences between generics and biosimilars
  • Manufacturing processes for biologics/biosimilars

After completing Module 1, the participants will understand:

  • The scientific differences between generics and biosimilars
  • The scientific differences between biosimilars and the reference biopharmaceuticals, including aspects such as immunogenicity

Key articles  / references for Module 1:

  • Bui LA, et al. Drug Discov Today. 2015;20 Suppl 1:3-15.
  • Mellstedt H, et al. Ann Oncol. 2008;19:411-9.
  • Ramanan S, Grampp G. BioDrugs. 2014;28:363-72.
  • Schiestl M, et al. Nat Biotechnol. 2011;29:310-2.
  • Tebbey PW, et al. MAbs. 2015;7:805-11.

Module 2: Checkpoints for biosimilars: insights into the regulatory framework 

Key content

  • Regulatory pathways and key international differences
  • International regulatory guidelines
  • Nomenclature and pharmacovigilance 

After completing Module 2, the participants will understand:

  • The legal framework for biosimilar approval
  • The importance of nomenclature in traceability and pharmacovigilance

Key articles  / references for Module 2:

  • Ahmed I, et al. Clin Ther. 2012;34:400-19.
  • Castañeda-Hernández G, et al. Joint Bone Spine. 2014;471-7.
  • Declerck P, et al. Curr Med Res Opin. 2015 Sep 23 [Epub ahead of print].
  • EMA Questions and answers on biosimilar medicines, 27 Sept 2012. EMA/837805/2011.Krishnan A, et al. Biosimilars. 2015;5:19-32.
  • WHO guidelines on the evaluation of similar biotherapeutic products (SBPs). Available here.

Module 3: Application of biosimilars: key considerations for healthcare professionals

Key contents:

  • Extrapolation, interchangeability, switching, and substitution of biologics and biosimilars

  • Safety and efficacy issues associated with extrapolation, interchangeability, and switching

  • Practical implications for healthcare professionals

After completing Module 3, the participants will understand:

  • Key considerations in data extrapolation, interchangeability, and substitution (non-medical switching)

  • The clinical implication of differences between biosimilars and reference biopharmaceuticals with regard to efficacy and safety

  • Practical implications for healthcare professionals

Key articles  / references for Module 3 (in alphabetical order):

  • BPCI Act. Biologics Price Competition and Innovation Act of 2009. Federal Register 2010; H.R. 3590-686-702.
  • Lucio SD, et al. Am J Health Syst Pharm. 2013;70:2004-17.
  • Puig L, et al. Actas Dermosfiliogr. 2015;106:550-4.
  • Scott BJ, et al. J Clin Pharmacol. 2015;55:S123-32.
  • WHO guidelines on the evaluation of similar biotherapeutic products (SBPs). Available here.

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