FDA to Release Long-Awaited Guidance on CMO Agreements, Biosimilars in 2013

By Zachary Brennan

- Last updated on GMT

Related tags Pharmacology

FDA to Release Long-Awaited Guidance in 2013
Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US Food and Drug Administration (FDA).

Quality agreements for CMOs are important to the FDA as each one is unique. The lack of such agreements or variability in what they entail can also cause shortages. Recently revised GMP guidance​ from the European Commission also includes provisions whereby quality agreements need to be discussed and agreed on by the manufacturer and the supplier.

Stephanie Wilkins, president of PharmaConsult Us, told in-Pharmatechnologist that industry will be most eagerly anticipating the quality agreement guidance, as well as GMP guidance on the control of highly potent compounds.

Other GMP-related guidance this year will include documents on:

  • Quality systemsrelated to cGMP regulation;
  • Uniformity of in-process mixtures;
  • Submission of field alert reports and biologic deviation reports;
  • Pre-launch activities related to importation requests.


In terms of new guidance on the chemistry and APIs of drugs, the FDA is also planning to release more on comparability protocols for approved drugs, specifically on the chemistry, manufacturing and controls information; elemental impurities; liposome drug products and immunogenicity considerations for low molecular weight heparins (LMWH).

The agency’s focus on securing the supply chain will also be on full display when the FDA releases guidance on the standards for the tracking and tracing of drug packages.


In addition, the FDA plans to release highly anticipated guidance in 2013 on the submission of clinical pharmacology data as evidence of biosimilarity for biologics and protein products. Formal meetings between the FDA and biosimilar sponsors or applicants will also be outlined in a guidance document.

The focus on biosimilars guidance from the FDA comes as the European Medicines Agency also recently released guidance​ on the non-clinical and clinical development of biosimilars containing LMWHs.

In vivo studies are no longer required as part of the comparability exercise if physicochemical and biological characterisation of the biosimilar and the reference LMWH has been performed with a high level of resolution and have demonstrated close similarity convincingly, according to the revised non-clinical section of the guideline. However, separate repeated-dose toxicity studies may be required in specific cases, for example when novel or less-well-studied excipients are introduced.

In terms of clinical studies, a comparative efficacy trial “is usually required as part of the comparability exercise,” but an efficacy study may be waived in exceptional situations, such as if similar efficacy of the biosimilar and the reference product can be convincingly deduced from the comparison of their physicochemical characteristics, biological activity, potency and pharmacodynamic fingerprint profiles, based on the use of highly sensitive and specific methods.

Comments on the EMA guideline are due July 31.

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