Last week’s round-up, 14 – 18 October 2019

By Tessa Fiorini-Cohen and Marthese Mifsud


Updated product-specific bioequivalence guidance

18 Oct 2019

The EMA has finalised product-specific bioequivalence guidance for seven drug substances.

The substances affected are alectinib, apixaban, cabozantinib, colchicine, ezetimibe, gefitinib, and palbociclib. All guidances were adopted on 15 October 2019. Those for apixaban and gefitinib will become legally effective on 1st February 2020, whereas the remaining guidances will become legally effective on 1st April 2020.We have collated links to all seven guidances here: http://bit.ly/RealGenerics-2Mt20Au


Citizen Petitions Delaying Approvals: FDA Finalizes Guidance

17 Oct 2019

Citizen petitions are delaying approval of generic drugs and biosimilars in the US, so the FDA has finalized guidance to help tackle this.

Last February, the FDA explained that citizen petitions and petitions for a stay of agency action are often submitted to delay the approval of competing drug products and do not raise valid scientific issues. The finalised guidance lists considerations that the agency will use from now on when assessing each petition, and supersedes previous guidance from 2014.

Considerations include submission of a petition close in time to a known first date upon which an abbreviated new drug application (ANDA) could be approved, substantial similarity to previous petitions, and serial petitions by the same petitioner. Requests that other applicants meet standards for testing, data, or labelling that are more rigorous than the standards the FDA has determined are necessary for the applicable drug are also included amongst the considerations. Final action on a petition will be taken within 150 days from submission, and this deadline will not be extended for any reason: http://bit.ly/RealGenerics-2BlLV97


Have FDA’s Generic Approvals Helped With Competition? Researchers Say Too Early to Tell

16 Oct 2019

The FDA’s efforts to promote generic drug competition have yet to make a noticeable impact, according to recent research published last week.

Over the past couple of years, the FDA has taken steps to promote generic drug development in areas where competition is lacking or where drugs are shortage-prone. However, although the number of abbreviated new drug applications (ANDAs) has trended upwards over the same time period, there hasn’t been the same effect in relation to the products particularly targeted by the FDA.

ANDAs take time for manufacturers to prepare, and another 6 to 12 months for regulatory review, so the measurable impact may soon grow. In fact, a number of applications are currently pending FDA action under both its priority ANDA and competitive generic therapy schemes: http://bit.ly/RealGenerics-2oA2lIt


European Pharmacopoeia has published three recent updates

15 Oct 2019

The EDQM has published three recent updates, related to Pharmeuropa 31.4 and European Pharmacopoeia Supplement 10.1.

CEP users have been invited to provide comments on draft monographs published in Pharmeuropa 31.4 before 31st December 2019. Monographs affected include ones for microcrystalline cellulose, zinc stearate, croscarmellose sodium and calcium stearate. A draft harmonised monograph on determination of elemental impurities has also been published, which is similarly open for comment until 31st December 2019.

CEP holders have also been invited to update their applications according to the revised monographs that will be implemented within supplement 10.1 of the European Pharmacopoeia. Implementation will take place on the 1st April 2020, and 27 monographs have been affected, including ones for rosuvastatin calcium, testosterone and benzocaine: http://bit.ly/RealGenerics-31fXDwJ


Can a molecule be classified as a dietary supplement just because it occurs in plants?

14 Oct 2019

The US District Court recently ruled that it cannot be classified as such, supporting the FDA’s previous decision on the matter. DMAA was sold by a particular pharmaceutical company as a dietary supplement in products marketed to bodybuilders. The company claimed that DMAA is a constituent of geraniums.

However, the FDA seized these products, classifying DMAA as a food additive rather than a dietary supplement. As a food additive, the product would have required premarket approval from the FDA. The main reasons that both the court and the FDA classified DMAA as a food additive is that the compound is not generally recognized as safe and has only been shown to be present in trace amounts in geraniums, rather than extractable or derivable from the plant. The same company has a similar ongoing lawsuit for another dietary supplement called DMHA (2-Aminoisopheptane HCI) which it claims naturally occurs in walnut trees, so further developments are expected: http://bit.ly/RealGenerics-2VEqedX


Image: pills, CC BY 2.0

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