The US Biosimilars Act

  title={The US Biosimilars Act},
  author={Cecil Nick},
  journal={Pharmaceutical Medicine},
  • C. Nick
  • Published 1 June 2012
  • Medicine
  • Pharmaceutical Medicine
Ever since the signing of the US healthcare reform legislation, the Patient Protection and Affordable Care Act (PPAC), speculation as to what a US FDA biosimilar programme might look like has been rife. Now the FDA has published guidance documents on biosimilar product development, which has been described by Dr Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research, as “an innovative approach to supporting the development of biosimilars at every step of the process… 
The objective of this report is to facilitate regulatory requirements for the approval process of Biosimilars and the need for Bi osimilar product class-specific guidelines in Regul ated and emerging markets.
Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development.
It is demonstrated that any differences observed during the physiochemical characterization of the biosimilar candidate do not result in meaningful biological or clinical differences in the performance of the candidate to ensure safety and efficacy.
Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community
Development of biosimilars is focused on the minimization of potential differences between the proposed biosimilar and reference product and the establishment of a robust manufacturing process to consistently produce a high-quality biosimilar product.
Biosimilar insulins are coming: what they are, what you need to know
The biosimilar insulins being developed have the potential to provide clinical benefits that are similar to current insulin analogs at a more affordable price, thereby allowing more patients greater access to these effective therapies.
Biosimilars: part 1: proposed regulatory criteria for FDA approval.
  • C. L. Ventola
  • Medicine, Political Science
    P & T : a peer-reviewed journal for formulary management
  • 2013
The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.
Review and results of a survey about biosimilars prescription and challenges in the Middle East and North Africa region
Only few physicians are aware of biosimilars presence in the market and do prescribe them in Lebanon and the Arab region, which could be mainly explained by lack of confidence in efficacy, safety, manufacturing process and price of these products, and lack of clear legislation.
Biotherapeutics and its applications in Microbiology
Comparative BPs (SBPs) are discussed here, also called biosimilars, including the assembly process and administrative viewpoints used.
Estimation and Approximation Approaches for Biosimilar Index Based on Reproducibility Probability
An estimate method for a biosimilar index and the related lower bound based on the concept of reproducibility probability by assessing power is proposed and some approximations are proposed and compared in regard to simplicity and accuracy.


Developing the nation's biosimilars program.
To improve access to biologic drugs, Congress authorized the FDA to create an abbreviated pathway for approving biologics that are “biosimilar” to approved products. Reconciling the science of
Guideline on Similar Biological Medicinal Products
Comments on this guideline submitted for public consultation are provided by PDA, a non-profit international professional association of more than 10,000 individual member scientists having an interest in the fields of pharmaceutical, biological, and device manufacturing and quality.
OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Evaluated results and behaviors and sexual activities will be used to examine experiences of participants in the RCT.
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The worldwide clamour for truth and justice, for human rights for all, has never been louder. But so is the cry of those subjected to the ever-growing range of abuses
From industry
Lieferant: Colora MeBtechnik GmbH, BarbarossastraBe 3, W-7073 Lorch Der programmierbare Thermoblock bietet die Annehmlichkeiten eines programmierbaren Mikroprozessors in Verbindung mit einem
Patient Protection and Affordable Care Act HR3590/Pub. L. No. 111–148
  • Patient Protection and Affordable Care Act HR3590/Pub. L. No. 111–148
  • 2010
BioCentury interview [online]. Available from URL: http://www. The+Pathway/924495749001
  • 2012
Available from URL: http://www
  • Available from URL: http://www
  • 2012
Guidance for industry: quality considerations in demonstrating biosimilarity to a reference protein product [online]. Available from URL:
  • Guidance for industry: quality considerations in demonstrating biosimilarity to a reference protein product [online]. Available from URL:
Guidance for industry : quality considerations in demonstrating Regulatory Challenges for US Biosimilars 151 Adis a 2012 Springer International Publishing AG . All rights reserved
  • Pharm Med
  • 2012